prompt,id,instruction,output,Train "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03809988,"{'Official Title': 'International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.', 'Brief Summary': 'Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)', 'Condition': 'Breast Cancer\nAdvanced Breast Cancer\nHormone Receptor Positive Tumor\nHuman Epidermal Growth Factor 2 Negative Carcinoma of Breast', 'Detailed Description': 'Pre- and post-menopausal women age ≥ 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH)', 'Inclusion Criteria': ""Inclusion Criteria:\n\nFemale patients over 18 years of age.\nPre-menopausal women provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/Follicle-stimulating hormone (FSH) must be confirmed analytically) prior to study entry or post- menopausal women as defined by any of the following criteria:\n\nAge ≥60 years;\nAge <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory's reference range for postmenopausal females;\nDocumented bilateral oophorectomy.\nEastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1.\nLife expectancy greater or equal to 12 weeks.\nHistologically proven diagnosed of ABC not amenable to curative treatment.\nDocumented recurrent ER-positive and/or progesterone receptor (PgR)-positive (with ≥1% positive stained cells (according to NCCN National Comprehensive Cancer Network and ASCO American Society of Clinical Oncology guidelines) and HER2-negative (0-1+ by immunohistochemistry (IHC) or 2+ and negative by in situ hybridization (ISH) test) breast cancer in the advanced setting.\nRadiological or clinical evidence of disease progression on first- line combination of palbociclib plus endocrine therapy (aromatase inhibitor (AI) or fulvestrant). Patients previously treated with the combination of palbociclib and tamoxifen will be excluded.\nPatients have achieved clinical benefit criteria to a first-line palbociclib-based endocrine regimen (defined as at least stable disease ≥ 24 weeks or partial or complete response confirmed or unconfirmed).\nPatients must have been treated with a stable minimum dose of 75 mg palbociclib during the last 2 cycles of the prior palbociclib-based regimen.\nLast dose of palbociclib administered not later than 8 weeks and not earlier than 7 days from study entry, with the exception of patients relapsing on a palbociclib-based regimen in the adjuvant setting.\nPatients should not have been treated in the advanced setting with at least one of these endocrine therapy options: either fulvestrant or AI.\nPatients must have measurable disease or evaluable disease according to RECIST criteria v.1.1. Patients with only bone lesions are eligible.\nWillingness and ability to provide tumor biopsy (if feasible) both at the time of the inclusion and after disease progression in order to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee.\nPatients agree to collection of blood samples (liquid biopsy) at the time of inclusion, after 2 weeks of treatment, and upon progression or study termination.\nAdequate organ function: (Hematological, hepatic and renal)\nPatients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\nPatients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.\nResolution of all acute toxic effects of prior anti-cancer therapy to grade 1""}",{'Arm - Disease - Indication': 'HR-Positive HER2-Negative Advanced Breast Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03809988,"{'Official Title': 'International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.', 'Brief Summary': 'Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)', 'Condition': 'Breast Cancer\r\nAdvanced Breast Cancer\r\nHormone Receptor Positive Tumor\r\nHuman Epidermal Growth Factor 2 Negative Carcinoma of Breast', 'Detailed Description': 'Pre- and post-menopausal women age ≥ 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH)', 'Inclusion Criteria': ""Inclusion Criteria:\n\nFemale patients over 18 years of age.\nPre-menopausal women provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/Follicle-stimulating hormone (FSH) must be confirmed analytically) prior to study entry or post- menopausal women as defined by any of the following criteria:\n\nAge ≥60 years;\nAge <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory's reference range for postmenopausal females;\nDocumented bilateral oophorectomy.\nEastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1.\nLife expectancy greater or equal to 12 weeks.\nHistologically proven diagnosed of ABC not amenable to curative treatment.\nDocumented recurrent ER-positive and/or progesterone receptor (PgR)-positive (with ≥1% positive stained cells (according to NCCN National Comprehensive Cancer Network and ASCO American Society of Clinical Oncology guidelines) and HER2-negative (0-1+ by immunohistochemistry (IHC) or 2+ and negative by in situ hybridization (ISH) test) breast cancer in the advanced setting.\nRadiological or clinical evidence of disease progression on first- line combination of palbociclib plus endocrine therapy (aromatase inhibitor (AI) or fulvestrant). Patients previously treated with the combination of palbociclib and tamoxifen will be excluded.\nPatients have achieved clinical benefit criteria to a first-line palbociclib-based endocrine regimen (defined as at least stable disease ≥ 24 weeks or partial or complete response confirmed or unconfirmed).\nPatients must have been treated with a stable minimum dose of 75 mg palbociclib during the last 2 cycles of the prior palbociclib-based regimen.\nLast dose of palbociclib administered not later than 8 weeks and not earlier than 7 days from study entry, with the exception of patients relapsing on a palbociclib-based regimen in the adjuvant setting.\nPatients should not have been treated in the advanced setting with at least one of these endocrine therapy options: either fulvestrant or AI.\nPatients must have measurable disease or evaluable disease according to RECIST criteria v.1.1. Patients with only bone lesions are eligible.\nWillingness and ability to provide tumor biopsy (if feasible) both at the time of the inclusion and after disease progression in order to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee.\nPatients agree to collection of blood samples (liquid biopsy) at the time of inclusion, after 2 weeks of treatment, and upon progression or study termination.\nAdequate organ function: (Hematological, hepatic and renal)\nPatients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\nPatients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.\nResolution of all acute toxic effects of prior anti-cancer therapy to grade 1""}",{'Arm - Disease - Indication': 'HR-Positive HER2-Negative Advanced Breast Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04158440,"{'Official Title': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.', 'Condition': 'Stage II-III Non-small Cell Lung Cancer', 'Detailed Description': 'Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below:\nDisease stage: II vs IIIA vs IIIB\nPD-L1 status: PD-L1 expression ≥1% vs. PD-L1 <1% or not evaluable\nPlanned surgical operation: pneumonectomy vs. lobectomy\nPathological type: non-squamous cell carcinoma vs. squamous cell carcinoma Neoadjuvant therapy should be started within 3 days after randomization. Toripalimab IV 240 mg Q3W /plaecbo will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group; Every 3 weeks of treatment is regarded as one cycle, in which combined therapy is given in the first day of every cycle.\nAll the subjects will receive preoperative radiological and surgical evaluation 3-5 weeks after neoadjuvant therapy.\nAfter 3 cycles of preoperative neoadjuvant therapy, all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy. The pTNM will be staged in accordance with AJCC Cancer Staging Manual (version 8). All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research.\nAll the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy, i.e., Toripalimab IV 240 mg/placebo + platinum-based doublet drug chemotherapy in 30 days after the operation. If there is no adjuvant radiotherapy plan, it will proceed to consolidation treatment period three weeks after adjuvant therapy; if adjuvant radiotherapy is planned then the consolidation treatment period will start 30 days after adjuvant radiotherapy. In the consolidation treatment period, Toripalimab IV 240 mg/placebo is given in each cycle of every 3 weeks for a total of 13 cycles . Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study.', 'Inclusion Criteria': 'Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);\nAged 18-70 years, male or female;\nTreatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as eligible for radical resection evaluated by a qualified thoracic surgeon; resectable stage III is defined as the resectable and potential resectable according to the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019)in which resectable includes IIIA(N0-1), partial N2 with single-station mediastinal lymph node metastasis and the short diameter of lymph node<2 cm， partial T4 (satellite nodules in the adjacent lobe) N1 and potential resectable includes partial stage IIIA and IIIB with the short diameter of single-station N2 mediastinal lymph node<3 cm, other potentially resectable T3 or T4 central tumor ; Any suspected lesions which could change the TNM stage, such as contralateral mediastinal lymph node, supraclavicular lymph mode, solid/sub-solid pulmonary node and non-isolated ground glass opacity (GGO), pathological confirmation is strongly recommended.\nMeasurable lesions based on the response evaluation criteria in solid tumors version 1.1;\nTumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment; tumor tissue specimens must be the samples of histological category, including but not limited to the tissue punctured by core needle and hollow needle, tissue acquired by bronchoscopic clamp, surgically resected samples; the samples acquired by fine needle puncture and bronchial brushing are not acceptable);\nECOG score 0-1;\nGood organ function:\nBeing willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;\npulmonary function test being able to withstand the planned pneumonectomy evaluated by surgeons; Women of childbearing potential must undergo serum pregnancy test within 3 hours prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug.\nWomen of childbearing potential must undergo serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug'}",{'Arm - Disease - Indication': 'Treatment-naive Resectable Stage II-III Non Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04158440,"{'Official Title': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.', 'Condition': 'Stage II-III Non-small Cell Lung Cancer', 'Detailed Description': 'Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below:\nDisease stage: II vs IIIA vs IIIB\nPD-L1 status: PD-L1 expression ≥1% vs. PD-L1 <1% or not evaluable\nPlanned surgical operation: pneumonectomy vs. lobectomy\nPathological type: non-squamous cell carcinoma vs. squamous cell carcinoma Neoadjuvant therapy should be started within 3 days after randomization. Toripalimab IV 240 mg Q3W /plaecbo will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group; Every 3 weeks of treatment is regarded as one cycle, in which combined therapy is given in the first day of every cycle.\nAll the subjects will receive preoperative radiological and surgical evaluation 3-5 weeks after neoadjuvant therapy.\nAfter 3 cycles of preoperative neoadjuvant therapy, all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy. The pTNM will be staged in accordance with AJCC Cancer Staging Manual (version 8). All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research.\nAll the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy, i.e., Toripalimab IV 240 mg/placebo + platinum-based doublet drug chemotherapy in 30 days after the operation. If there is no adjuvant radiotherapy plan, it will proceed to consolidation treatment period three weeks after adjuvant therapy; if adjuvant radiotherapy is planned then the consolidation treatment period will start 30 days after adjuvant radiotherapy. In the consolidation treatment period, Toripalimab IV 240 mg/placebo is given in each cycle of every 3 weeks for a total of 13 cycles . Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study.', 'Inclusion Criteria': 'Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);\nAged 18-70 years, male or female;\nTreatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as eligible for radical resection evaluated by a qualified thoracic surgeon; resectable stage III is defined as the resectable and potential resectable according to the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019)in which resectable includes IIIA(N0-1), partial N2 with single-station mediastinal lymph node metastasis and the short diameter of lymph node<2 cm， partial T4 (satellite nodules in the adjacent lobe) N1 and potential resectable includes partial stage IIIA and IIIB with the short diameter of single-station N2 mediastinal lymph node<3 cm, other potentially resectable T3 or T4 central tumor ; Any suspected lesions which could change the TNM stage, such as contralateral mediastinal lymph node, supraclavicular lymph mode, solid/sub-solid pulmonary node and non-isolated ground glass opacity (GGO), pathological confirmation is strongly recommended.\nMeasurable lesions based on the response evaluation criteria in solid tumors version 1.1;\nTumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment; tumor tissue specimens must be the samples of histological category, including but not limited to the tissue punctured by core needle and hollow needle, tissue acquired by bronchoscopic clamp, surgically resected samples; the samples acquired by fine needle puncture and bronchial brushing are not acceptable);\nECOG score 0-1;\nGood organ function:\nBeing willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;\npulmonary function test being able to withstand the planned pneumonectomy evaluated by surgeons; Women of childbearing potential must undergo serum pregnancy test within 3 hours prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug.\nWomen of childbearing potential must undergo serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug'}",{'Arm - Disease - Indication': 'Treatment-naive Resectable Stage II-III Non Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02853331,"{'Official Title': 'A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC).\nThe primary hypotheses of this study are:\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features\nHas locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease\nHas measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist\nHas received no prior systemic therapy for advanced RCC.\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.\nHas Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to randomization.\nIf receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.\nDemonstrates adequate organ function.\nFemale participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.\nMale participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.'}",{'Arm - Disease - Indication': 'First-line Locally Advanced or Advanced or Metastatic Clear Cell Renal Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02853331,"{'Official Title': 'A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC).\nThe primary hypotheses of this study are:\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features\nHas locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease\nHas measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist\nHas received no prior systemic therapy for advanced RCC.\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.\nHas Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to randomization.\nIf receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.\nDemonstrates adequate organ function.\nFemale participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.\nMale participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.'}",{'Arm - Disease - Indication': 'First-line Locally Advanced or Advanced or Metastatic Clear Cell Renal Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04744831,"{'Official Title': 'A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)', 'Brief Summary': 'This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).', 'Condition': 'Advanced Colorectal Cancer', 'Detailed Description': 'This 2-stage study will evaluate participants with locally advanced, unresectable, or metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC 2+/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor type, previously treated with standard therapy. In the first stage, participants will be randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further eligible participants will be registered to T-DXd administered IV in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.', 'Inclusion Criteria': 'KEY Inclusion Criteria:\nParticipants must meet all of the following criteria to be eligible for randomization/registration into the study:\nAdults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥18 years in other countries, at the time the Informed Consent Forms (ICFs) are signed.\nPathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status identified in primary or metastatic site.\nThe following therapies should be included in prior lines of therapy:\nFluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated\nAnti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type and if clinically indicated\nAnti-vascular endothelial growth factor (VEGF) treatment, if clinically indicated\nAnti-programmed death ligand 1 (PD-(L)-1) therapy, if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high, if clinically indicated\nConfirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ hybridization (ISH) +.\nPresence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.\nEastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\nHas left ventricular ejection fraction (LVEF) ≥50% within 28 days before randomization/registration.'}",{'Arm - Disease - Indication': 'HER2-Overexpressing BRAF Wild-type Locally Advanced or Advanced Recurrent Unresectable or Metastatic Colorectal Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04744831,"{'Official Title': 'A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)', 'Brief Summary': 'This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).', 'Condition': 'Advanced Colorectal Cancer', 'Detailed Description': 'This 2-stage study will evaluate participants with locally advanced, unresectable, or metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC 2+/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor type, previously treated with standard therapy. In the first stage, participants will be randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further eligible participants will be registered to T-DXd administered IV in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.', 'Inclusion Criteria': 'KEY Inclusion Criteria:\nParticipants must meet all of the following criteria to be eligible for randomization/registration into the study:\nAdults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥18 years in other countries, at the time the Informed Consent Forms (ICFs) are signed.\nPathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status identified in primary or metastatic site.\nThe following therapies should be included in prior lines of therapy:\nFluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated\nAnti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type and if clinically indicated\nAnti-vascular endothelial growth factor (VEGF) treatment, if clinically indicated\nAnti-programmed death ligand 1 (PD-(L)-1) therapy, if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high, if clinically indicated\nConfirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ hybridization (ISH) +.\nPresence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.\nEastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\nHas left ventricular ejection fraction (LVEF) ≥50% within 28 days before randomization/registration.'}",{'Arm - Disease - Indication': 'HER2-Overexpressing BRAF Wild-type Locally Advanced or Advanced Recurrent Unresectable or Metastatic Colorectal Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02998528,"{'Official Title': 'Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC', 'Brief Summary': ""The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.\nThis study has multiple primary endpoints."", 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nEarly stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\nLung function capacity capable of tolerating the proposed lung surgery\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\nAvailable tissue of primary lung tumor'}",{'Arm - Disease - Indication': 'Early Stage IB-IIIA Resectable Non Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02998528,"{'Official Title': 'Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC', 'Brief Summary': ""The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.\nThis study has multiple primary endpoints."", 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nEarly stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\nLung function capacity capable of tolerating the proposed lung surgery\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\nAvailable tissue of primary lung tumor'}",{'Arm - Disease - Indication': 'Early Stage IB-IIIA Resectable Non Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02998528,"{'Official Title': 'Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC', 'Brief Summary': ""The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.\nThis study has multiple primary endpoints."", 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nEarly stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\nLung function capacity capable of tolerating the proposed lung surgery\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\nAvailable tissue of primary lung tumor'}",{'Arm - Disease - Indication': 'Early Stage IB-IIIA Resectable Non Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04334941,"{'Official Title': 'Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination With Talazoparib in Patients With SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'Brief Summary': ""This phase II trial studies whether atezolizumab in combination with talazoparib works better than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body's instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control, but PARP inhibitors like talazoparib may keep PARP from working, so tumor cells can't repair themselves, and they stop growing. Giving atezolizumab in combination with talazoparib may help lower the chance of extensive-stage small cell lung cancer growing and spreading compared to atezolizumab alone."", 'Condition': 'Extensive Stage Lung Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare progression free survival (PFS) among participants with Schlafen family member 11 (SLFN11) positive extensive stage small cell lung cancer (ES-SCLC) randomized to atezolizumab or atezolizumab plus talazoparib as maintenance therapy.\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) between the arms. II. To compare objective response rate (ORR) among participants with measurable disease between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\nIII. To evaluate the frequency and severity of adverse events within each treatment arm.\nTRANSLATIONAL MEDICINE OBJECTIVE:\nI. To bank specimens for future correlative studies.\nOUTLINE: Patients are screened for SLFN11 biomarker during Step 1: Screening Registration by submitting tumor tissue to MDACC. Patients with SLFN11 biomarker are registered to Step 2: Randomization and are randomized to 1 or 2 arms.\nARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1 and talazoparib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nPatients may undergo magnetic resonance imaging (MRI) during screening. Patients undergo tumor biopsy while on study. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.', 'Inclusion Criteria': 'STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible\nSTEP 1: SCREENING REGISTRATION: Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab\nNOTE: Participants may be screened while receiving consolidation thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and/or PCI per the discretion of their treating investigator\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must be >= 18 years of age at the time of Step 1 Screening Registration\nSTEP 1: SCREENING REGISTRATION: Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as:\nAt least two (3-5 microns) (three slides preferred) unstained slides, or;\nOne (3-5 microns) (two slides preferred) unstained slide plus one H&E stained slide\nParticipants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing. Note: A histologic review will be performed at MDACC to confirm adequate cellularity for the testing. If inadequate cellularity, additional unstained slides from the same participant may be submitted if it doesn\'t exceed the window of starting maintenance therapy\nSTEP 1: SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 1: SCREENING REGISTRATION: As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 1: SCREENING REGISTRATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\nSTEP 2: RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) that the participant\'s tumor sample is SLFN11 positive\nSTEP 2: RANDOMIZATION: Participants must have their disease assessed either by computed tomography (CT) of chest/abdomen/pelvis (with contrast, unless contraindicated) within 28 days prior to Step 2 Registration for measurable disease or by positron emission tomography (PET)PET/CT of chest/abdomen/pelvis (with contrast, unless contraindicated) within 42 days prior to Step 2 Registration for non-measurable disease. Participants may have a complete response to induction therapy. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Study participants will not be considered eligible if a non-diagnostic PET/CT of chest/abdomen/pelvis is used to assess measurable disease prior to Step 2 Registration\nSTEP 2: RANDOMIZATION: Patients must have a CT or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 randomization. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to Step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must not have had disease progression based on post induction imaging in the opinion of treating investigator\nSTEP 2: RANDOMIZATION: Participants must be registered to Step 2 Randomization prior to the start of maintenance atezolizumab\nSTEP 2: RANDOMIZATION: Participants must have received no fewer than 2 cycles and no more than 4 cycles of induction treatment with platinum/etoposide/atezolizumab\nSTEP 2: RANDOMIZATION: Participant must not have received radiation treatment (RT) or prophylactic cranial irradiation (PCI) within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be taking strong P-glycoprotein (P-gp) inhibitors (e.g., dronedarone, quinidine, ranolazine), P-gp inducers (e.g., rifampin), or breast cancer resistance protein (BCRP) inhibitors (e.g., elacridar) within 7 days prior to randomization. Participants must not plan to receive the therapies listed above while on protocol treatment)\nSTEP 2: RANDOMIZATION: Participants must not have experienced the following during induction treatment:\nAny grade 3 or worse immune-related adverse event (irAE) in the opinion of the treating investigator. Exception: asymptomatic nonbullous/nonexfoliative rash\nAny unresolved grade 2 irAE\nAny toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy. Exception to the above: Toxicities of any grade that require replacement therapy and have stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed\nSTEP 2: RANDOMIZATION: History and physical exam must be obtained within 28 days prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function and be considered class 2B or better on the New York Heart Association Functional Classification\nSTEP 2: RANDOMIZATION: Participants must have Zubrod performance status 0-2 documented within 28 days prior to Step 2 Randomization.\nSTEP 2: RANDOMIZATION: Leukocytes >= 3 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Absolute neutrophil count >= 1.5 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Platelets >= 100 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Creatinine =< institutional ULN OR estimated creatinine clearance > 30 mL/min (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be able to swallow capsule whole\nSTEP 2: RANDOMIZATION: Participants with known diabetes must not have uncontrolled diabetes. (Uncontrolled diabetes is defined as glycosylated hemoglobin [HgA1C] > 7%)\nSTEP 2: RANDOMIZATION: Participants must not have any known clinically significant liver disease, including cirrhosis, fatty liver, or inherited liver disease\nSTEP 2: RANDOMIZATION: Participants must not have end stage renal or other serious medical illness that may limit survival or the ability to participate in this study\nSTEP 2: RANDOMIZATION: Participants must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\nSTEP 2: RANDOMIZATION: Participants must not have known active tuberculosis (TB)\nSTEP 2: RANDOMIZATION: Participants must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation\nSTEP 2: RANDOMIZATION: Participants must not have history of allergic reaction attributed to compounds of similar chemical or biological composition to atezolizumab and/or talazoparib\nSTEP 2: RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\nSTEP 2: RANDOMIZATION: Participants must not be on corticosteroids at doses greater than prednisone 10 mg daily or equivalent within 7 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not receive any live attenuated vaccines within 28 days prior to Step 2 Randomization or at any time during the study and until 5 months after the last dose of protocol treatment\nSTEP 2: RANDOMIZATION: Participants must not have severe infections in the form of severe sepsis or septic shock including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 7 months after the last dose of protocol treatment. A woman is considered to be of ""reproductive potential"" if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, ""effective contraception"" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\nSTEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 2: RANDOMIZATION: As a part of the OPEN registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 2: RANDOMIZATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)'}",{'Arm - Disease - Indication': 'SLFN11-Positive Extensive-Stage Small Cell Lung Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04334941,"{'Official Title': 'Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination With Talazoparib in Patients With SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'Brief Summary': ""This phase II trial studies whether atezolizumab in combination with talazoparib works better than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body's instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control, but PARP inhibitors like talazoparib may keep PARP from working, so tumor cells can't repair themselves, and they stop growing. Giving atezolizumab in combination with talazoparib may help lower the chance of extensive-stage small cell lung cancer growing and spreading compared to atezolizumab alone."", 'Condition': 'Extensive Stage Lung Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare progression free survival (PFS) among participants with Schlafen family member 11 (SLFN11) positive extensive stage small cell lung cancer (ES-SCLC) randomized to atezolizumab or atezolizumab plus talazoparib as maintenance therapy.\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) between the arms. II. To compare objective response rate (ORR) among participants with measurable disease between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\nIII. To evaluate the frequency and severity of adverse events within each treatment arm.\nTRANSLATIONAL MEDICINE OBJECTIVE:\nI. To bank specimens for future correlative studies.\nOUTLINE: Patients are screened for SLFN11 biomarker during Step 1: Screening Registration by submitting tumor tissue to MDACC. Patients with SLFN11 biomarker are registered to Step 2: Randomization and are randomized to 1 or 2 arms.\nARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1 and talazoparib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nPatients may undergo magnetic resonance imaging (MRI) during screening. Patients undergo tumor biopsy while on study. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.', 'Inclusion Criteria': 'STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible\nSTEP 1: SCREENING REGISTRATION: Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab\nNOTE: Participants may be screened while receiving consolidation thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and/or PCI per the discretion of their treating investigator\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must be >= 18 years of age at the time of Step 1 Screening Registration\nSTEP 1: SCREENING REGISTRATION: Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as:\nAt least two (3-5 microns) (three slides preferred) unstained slides, or;\nOne (3-5 microns) (two slides preferred) unstained slide plus one H&E stained slide\nParticipants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing. Note: A histologic review will be performed at MDACC to confirm adequate cellularity for the testing. If inadequate cellularity, additional unstained slides from the same participant may be submitted if it doesn\'t exceed the window of starting maintenance therapy\nSTEP 1: SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 1: SCREENING REGISTRATION: As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 1: SCREENING REGISTRATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\nSTEP 2: RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) that the participant\'s tumor sample is SLFN11 positive\nSTEP 2: RANDOMIZATION: Participants must have their disease assessed either by computed tomography (CT) of chest/abdomen/pelvis (with contrast, unless contraindicated) within 28 days prior to Step 2 Registration for measurable disease or by positron emission tomography (PET)PET/CT of chest/abdomen/pelvis (with contrast, unless contraindicated) within 42 days prior to Step 2 Registration for non-measurable disease. Participants may have a complete response to induction therapy. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Study participants will not be considered eligible if a non-diagnostic PET/CT of chest/abdomen/pelvis is used to assess measurable disease prior to Step 2 Registration\nSTEP 2: RANDOMIZATION: Patients must have a CT or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 randomization. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to Step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must not have had disease progression based on post induction imaging in the opinion of treating investigator\nSTEP 2: RANDOMIZATION: Participants must be registered to Step 2 Randomization prior to the start of maintenance atezolizumab\nSTEP 2: RANDOMIZATION: Participants must have received no fewer than 2 cycles and no more than 4 cycles of induction treatment with platinum/etoposide/atezolizumab\nSTEP 2: RANDOMIZATION: Participant must not have received radiation treatment (RT) or prophylactic cranial irradiation (PCI) within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be taking strong P-glycoprotein (P-gp) inhibitors (e.g., dronedarone, quinidine, ranolazine), P-gp inducers (e.g., rifampin), or breast cancer resistance protein (BCRP) inhibitors (e.g., elacridar) within 7 days prior to randomization. Participants must not plan to receive the therapies listed above while on protocol treatment)\nSTEP 2: RANDOMIZATION: Participants must not have experienced the following during induction treatment:\nAny grade 3 or worse immune-related adverse event (irAE) in the opinion of the treating investigator. Exception: asymptomatic nonbullous/nonexfoliative rash\nAny unresolved grade 2 irAE\nAny toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy. Exception to the above: Toxicities of any grade that require replacement therapy and have stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed\nSTEP 2: RANDOMIZATION: History and physical exam must be obtained within 28 days prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function and be considered class 2B or better on the New York Heart Association Functional Classification\nSTEP 2: RANDOMIZATION: Participants must have Zubrod performance status 0-2 documented within 28 days prior to Step 2 Randomization.\nSTEP 2: RANDOMIZATION: Leukocytes >= 3 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Absolute neutrophil count >= 1.5 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Platelets >= 100 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Creatinine =< institutional ULN OR estimated creatinine clearance > 30 mL/min (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be able to swallow capsule whole\nSTEP 2: RANDOMIZATION: Participants with known diabetes must not have uncontrolled diabetes. (Uncontrolled diabetes is defined as glycosylated hemoglobin [HgA1C] > 7%)\nSTEP 2: RANDOMIZATION: Participants must not have any known clinically significant liver disease, including cirrhosis, fatty liver, or inherited liver disease\nSTEP 2: RANDOMIZATION: Participants must not have end stage renal or other serious medical illness that may limit survival or the ability to participate in this study\nSTEP 2: RANDOMIZATION: Participants must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\nSTEP 2: RANDOMIZATION: Participants must not have known active tuberculosis (TB)\nSTEP 2: RANDOMIZATION: Participants must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation\nSTEP 2: RANDOMIZATION: Participants must not have history of allergic reaction attributed to compounds of similar chemical or biological composition to atezolizumab and/or talazoparib\nSTEP 2: RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\nSTEP 2: RANDOMIZATION: Participants must not be on corticosteroids at doses greater than prednisone 10 mg daily or equivalent within 7 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not receive any live attenuated vaccines within 28 days prior to Step 2 Randomization or at any time during the study and until 5 months after the last dose of protocol treatment\nSTEP 2: RANDOMIZATION: Participants must not have severe infections in the form of severe sepsis or septic shock including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 7 months after the last dose of protocol treatment. A woman is considered to be of ""reproductive potential"" if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, ""effective contraception"" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\nSTEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 2: RANDOMIZATION: As a part of the OPEN registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 2: RANDOMIZATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)'}",{'Arm - Disease - Indication': 'SLFN11-Positive Extensive-Stage Small Cell Lung Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01957436,"{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': ""Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials.""}",{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01957436,"{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': ""Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials.""}",{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01957436,"{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': ""Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials.""}",{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01957436,"{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': ""Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials.""}",{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04482309,"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}",{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Biliary Tract Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04482309,"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}",{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Bladder Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04482309,"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}",{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Cervical Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04482309,"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}",{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04482309,"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}",{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Ovarian Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04482309,"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}",{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Pancreatic Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04482309,"{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}",{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Rare Tumor'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03635567,"{'Official Title': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.\nThe primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)\nNot pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab\nHas measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization\nHas adequate organ function'}",{'Arm - Disease - Indication': 'Adult First-Line Persistent Recurrent or Metastatic Cervical Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03635567,"{'Official Title': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.\nThe primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)\nNot pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab\nHas measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization\nHas adequate organ function'}",{'Arm - Disease - Indication': 'Adult First-Line Persistent Recurrent or Metastatic Cervical Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03907488,"{'Official Title': 'A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma', 'Brief Summary': ""This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back."", 'Condition': 'Ann Arbor Stage III Hodgkin Lymphoma\nAnn Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Hodgkin Lymphoma\nAnn Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nClassic Hodgkin Lymphoma\nLymphocyte-Rich Classic Hodgkin Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin hydrochloride [doxorubicin], vinblastine sulfate [vinblastine], dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.\nII. To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.\nIII. To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.\nIV. To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.\nV. To compare patient-reported symptoms using selected Patient Reported Outcome Common Toxicity Criteria for Adverse Events (PRO-CTCAE) items between arms stratified by age groups.\nVI. To compare the safety and tolerability of N-AVD versus that of BV-AVD.\nQUALITY OF LIFE OBJECTIVE:\nI. To compare between arms patient-reported fatigue, neuropathy and health-related quality of life over time (baseline, beginning of cycle 3, 4-8 weeks after the last dose of protocol therapy [following last dose of study drug or radiation therapy, whichever is later], and 1 and 3 years after randomization) using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and the PROMIS Global, respectively.\nBANKING OBJECTIVES:\nI. To bank specimens for future correlative studies. II. To bank positron emission tomography (PET)-computed tomography (CT) images for future correlative studies.\nOUTLINE: Patients are randomized to 1 of 2 arms.\nARM I: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim subcutaneously (SC) on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and/or magnetic resonance imaging (MRI) on study.\nARM II: Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.\nAfter completion of study treatment and prior to disease progression, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration. Patients are followed up at the time of progression and then annually until 10 years after registration. Patients who receive radiation therapy are followed up at 8-12 weeks after completion of radiation therapy.', 'Inclusion Criteria': 'Inclusion Criteria:\nAll patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible.\nPatients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave.\nPatients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, MRI or MR-PET is acceptable in event that PET-CT is contra-indicated, however if it is later possible to administer a PET-CT, then PET-CT is strongly preferred for the interim scan (after cycle 2) (if performed) and the EOT assessment. Otherwise, if PET-CT is not subsequently possible, then the same modality as baseline must be used throughout the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted.\nPatients must be >= 12 years of age.\nPatients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted.\nPatients must not have had prior solid organ transplant.\nPatients must not have had prior allogeneic stem cell transplantation.\nPatients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid).\nAt registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator\'s intent-to-treat with residual PET RT.\nAll pediatric patients (< 18 years of age) will be considered intent-to-treat with Residual PET RT at time of registration.\nPatients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients =< 17 years of age. *The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only.\nAdults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight.\nPediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration:\nMeasured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or\nSerum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows:\nAge < 13 maximum serum creatinine: Male 1.2 mg/dL; Female 1.2 mg/dL\nAge 13 to < 16 maximum serum creatinine: Male 1.5 mg/dL; Female 1.4 mg/dL\nAge 16-17 maximum serum creatinine: Male 1.7 mg/dL; Female 1.4 mg/dL\nTotal bilirubin =< 2 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nPatients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction >= 50% or a shortening fraction of >= 27%. For all patients, the ECHO, MUGA, or functional cardiac imaging scan must be performed within 42 days prior to registration.\nPatients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable or unquantifiable viral load at their most recent viral load test within 6 months prior to registration.\nPatients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load within 6 months prior to registration and no residual hepatic impairment are eligible.\nPatients must not have any known central nervous system lymphoma.\nPatients must not have a history of or active interstitial pneumonitis or interstitial lung disease.\nPatients must not have had a diagnosis of inherited or acquired immunodeficiency.\nPatients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\nPatients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1.\nPatients with peripheral neuropathy must have < grade 2 at date of registration.\nPatients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn\'s disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener\'s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.\nNo second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years.\nFemales of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of ""reproductive potential"" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, ""effective contraception"" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.\nPatients must have one formalin-fixed paraffin embedded (FFPE) diagnostic tumor block or at least 1 diagnostic, 4-5 micron, hematoxylin and eosin (H&E) slide collected prior to registration and available for submission.\nPatients must be offered participation in banking for planned translational medicine and future research. With patient consent, any residuals from the mandatory tissue submission will also be banked for future research.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must complete the PROMIS Fatigue, the FACT/GOG-Ntx, and the PROMIS Global prior to registration.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must also agree to complete the PROMIS Fatigue, the FACT/GOG-Ntx, the PROMIS Global, and the PRO-CTCAE (or Pediatric [Ped] PRO-CTCAE) at the scheduled on-study assessment timepoints.\nPatients must be informed of the investigational nature of this study and all patients and/or their parents or legal guardians (for patients < 18 years of age) must sign and give informed consent and assent (where appropriate) in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board Initiative (CIRB) regulations.'}",{'Arm - Disease - Indication': 'Newly Diagnosed Previously Untreated Advanced Stage III Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Classical Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Lymphocyte-Rich Classic Hodgkin Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03907488,"{'Official Title': 'A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma', 'Brief Summary': ""This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back."", 'Condition': 'Ann Arbor Stage III Hodgkin Lymphoma\nAnn Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Hodgkin Lymphoma\nAnn Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nClassic Hodgkin Lymphoma\nLymphocyte-Rich Classic Hodgkin Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin hydrochloride [doxorubicin], vinblastine sulfate [vinblastine], dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.\nII. To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.\nIII. To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.\nIV. To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.\nV. To compare patient-reported symptoms using selected Patient Reported Outcome Common Toxicity Criteria for Adverse Events (PRO-CTCAE) items between arms stratified by age groups.\nVI. To compare the safety and tolerability of N-AVD versus that of BV-AVD.\nQUALITY OF LIFE OBJECTIVE:\nI. To compare between arms patient-reported fatigue, neuropathy and health-related quality of life over time (baseline, beginning of cycle 3, 4-8 weeks after the last dose of protocol therapy [following last dose of study drug or radiation therapy, whichever is later], and 1 and 3 years after randomization) using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and the PROMIS Global, respectively.\nBANKING OBJECTIVES:\nI. To bank specimens for future correlative studies. II. To bank positron emission tomography (PET)-computed tomography (CT) images for future correlative studies.\nOUTLINE: Patients are randomized to 1 of 2 arms.\nARM I: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim subcutaneously (SC) on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and/or magnetic resonance imaging (MRI) on study.\nARM II: Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.\nAfter completion of study treatment and prior to disease progression, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration. Patients are followed up at the time of progression and then annually until 10 years after registration. Patients who receive radiation therapy are followed up at 8-12 weeks after completion of radiation therapy.', 'Inclusion Criteria': 'Inclusion Criteria:\nAll patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible.\nPatients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave.\nPatients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, MRI or MR-PET is acceptable in event that PET-CT is contra-indicated, however if it is later possible to administer a PET-CT, then PET-CT is strongly preferred for the interim scan (after cycle 2) (if performed) and the EOT assessment. Otherwise, if PET-CT is not subsequently possible, then the same modality as baseline must be used throughout the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted.\nPatients must be >= 12 years of age.\nPatients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted.\nPatients must not have had prior solid organ transplant.\nPatients must not have had prior allogeneic stem cell transplantation.\nPatients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid).\nAt registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator\'s intent-to-treat with residual PET RT.\nAll pediatric patients (< 18 years of age) will be considered intent-to-treat with Residual PET RT at time of registration.\nPatients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients =< 17 years of age. *The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only.\nAdults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight.\nPediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration:\nMeasured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or\nSerum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows:\nAge < 13 maximum serum creatinine: Male 1.2 mg/dL; Female 1.2 mg/dL\nAge 13 to < 16 maximum serum creatinine: Male 1.5 mg/dL; Female 1.4 mg/dL\nAge 16-17 maximum serum creatinine: Male 1.7 mg/dL; Female 1.4 mg/dL\nTotal bilirubin =< 2 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nPatients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction >= 50% or a shortening fraction of >= 27%. For all patients, the ECHO, MUGA, or functional cardiac imaging scan must be performed within 42 days prior to registration.\nPatients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable or unquantifiable viral load at their most recent viral load test within 6 months prior to registration.\nPatients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load within 6 months prior to registration and no residual hepatic impairment are eligible.\nPatients must not have any known central nervous system lymphoma.\nPatients must not have a history of or active interstitial pneumonitis or interstitial lung disease.\nPatients must not have had a diagnosis of inherited or acquired immunodeficiency.\nPatients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\nPatients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1.\nPatients with peripheral neuropathy must have < grade 2 at date of registration.\nPatients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn\'s disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener\'s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.\nNo second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years.\nFemales of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of ""reproductive potential"" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, ""effective contraception"" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.\nPatients must have one formalin-fixed paraffin embedded (FFPE) diagnostic tumor block or at least 1 diagnostic, 4-5 micron, hematoxylin and eosin (H&E) slide collected prior to registration and available for submission.\nPatients must be offered participation in banking for planned translational medicine and future research. With patient consent, any residuals from the mandatory tissue submission will also be banked for future research.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must complete the PROMIS Fatigue, the FACT/GOG-Ntx, and the PROMIS Global prior to registration.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must also agree to complete the PROMIS Fatigue, the FACT/GOG-Ntx, the PROMIS Global, and the PRO-CTCAE (or Pediatric [Ped] PRO-CTCAE) at the scheduled on-study assessment timepoints.\nPatients must be informed of the investigational nature of this study and all patients and/or their parents or legal guardians (for patients < 18 years of age) must sign and give informed consent and assent (where appropriate) in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board Initiative (CIRB) regulations.'}",{'Arm - Disease - Indication': 'Newly Diagnosed Previously Untreated Advanced Stage III Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Classical Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Lymphocyte-Rich Classic Hodgkin Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03391466,"{'Official Title': 'A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma', 'Brief Summary': 'The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).', 'Condition': 'Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)', 'Detailed Description': 'This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy. After completing the treatment period, all subjects will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, subjects who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968.', 'Inclusion Criteria': 'Key Inclusion Criteria:\nHistologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016)\nDLBCL not otherwise specified (ABC/GCB)\nHGBL with or without MYC and BCL2 and/or BCL6 rearrangement\nDLBCL arising from FL\nT-cell/histiocyte rich large B-cell lymphoma\nDLBCL associated with chronic inflammation\nPrimary cutaneous DLBCL, leg type\nEpstein-Barr virus (EBV) + DLBCL\nRelapsed or refractory disease after first-line chemoimmunotherapy\nRefractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded.\nProgressive disease (PD) as best response to first-line therapy\nStable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\nPartial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 12 months of therapy\nRelapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy\nIndividuals must have received adequate first-line therapy including at a minimum:\nAnti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\nAn anthracycline containing chemotherapy regimen\nNo known history or suspicion of central nervous system involvement by lymphoma\nEastern cooperative oncology group (ECOG) performance status of 0 or 1\nAdequate bone marrow function as evidenced by:\nAbsolute neutrophil count (ANC) ≥ 1000/uL\nPlatelet ≥ 75,000/uL\nAbsolute lymphocyte count ≥ 100/uL\nAdequate renal, hepatic, cardiac, and pulmonary function as evidenced by:\nCreatinine clearance (Cockcroft Gault) ≥ 60 mL/min\nSerum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN)\nTotal bilirubin ≤ 1.5 mg/dl\nCardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\nNo clinically significant pleural effusion\nBaseline oxygen saturation > 92% on room air'}",{'Arm - Disease - Indication': 'Adult Second-Line Relapsed/Refractory Diffuse Large B Cell Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03391466,"{'Official Title': 'A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma', 'Brief Summary': 'The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).', 'Condition': 'Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)', 'Detailed Description': 'This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy. After completing the treatment period, all subjects will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, subjects who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968.', 'Inclusion Criteria': 'Key Inclusion Criteria:\nHistologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016)\nDLBCL not otherwise specified (ABC/GCB)\nHGBL with or without MYC and BCL2 and/or BCL6 rearrangement\nDLBCL arising from FL\nT-cell/histiocyte rich large B-cell lymphoma\nDLBCL associated with chronic inflammation\nPrimary cutaneous DLBCL, leg type\nEpstein-Barr virus (EBV) + DLBCL\nRelapsed or refractory disease after first-line chemoimmunotherapy\nRefractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded.\nProgressive disease (PD) as best response to first-line therapy\nStable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\nPartial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 12 months of therapy\nRelapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy\nIndividuals must have received adequate first-line therapy including at a minimum:\nAnti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\nAn anthracycline containing chemotherapy regimen\nNo known history or suspicion of central nervous system involvement by lymphoma\nEastern cooperative oncology group (ECOG) performance status of 0 or 1\nAdequate bone marrow function as evidenced by:\nAbsolute neutrophil count (ANC) ≥ 1000/uL\nPlatelet ≥ 75,000/uL\nAbsolute lymphocyte count ≥ 100/uL\nAdequate renal, hepatic, cardiac, and pulmonary function as evidenced by:\nCreatinine clearance (Cockcroft Gault) ≥ 60 mL/min\nSerum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN)\nTotal bilirubin ≤ 1.5 mg/dl\nCardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\nNo clinically significant pleural effusion\nBaseline oxygen saturation > 92% on room air'}",{'Arm - Disease - Indication': 'Adult Second-Line Relapsed/Refractory Diffuse Large B Cell Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03936270,"{'Official Title': 'Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer.', 'Brief Summary': 'The primary objective of this study is to evaluate 12 weeks progression-free survival (PFS) rate of Palbociclib plus Letrozole in ER/PR positive endometrioid or high-grade serous ovarian cancer who have disease progression on second-line chemotherapy.', 'Condition': 'Ovarian Cancer', 'Detailed Description': 'Letrozole (Femara®) is an oral non-steroidal aromatase inhibitor that is approved worldwide for the treatment of postmenopausal women with breast cancer. It is administered orally on a continuous 2.5 mg daily dosing regimen and has a good toxicity profile. Palbociclib (Ibrance®) is an active potent and highly selective reversible inhibitor of cyclin- dependent kinases 4 and 6 (CDK4/6). Palbociclib was approved by the United States Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor based on a randomized, double-blind, placebo-controlled, international clinical trial PALOMA-2. It is administered orally on a dose of 125 mg per day in 4-week cycles (3 weeks of treatment followed by 1 week off). This trial was based on preclinical studies that showed a synergistic effect between targeting the ER and cyclin-D-CDK4/6-Rb pathway. The principal toxicity was myelotoxicity but it was managed with appropriate supportive care and dose reductions13.\n\nBased on the results of phase 1 and 2 clinical trials of CDK4/6 inhibitors used as monotherapy to treat patients with recurrent ovarian cancer, we hypothesized that, as Palbociclibe is active in this population and many ovarian cancer show ER/PR expression, its combination with Letrozole can improve outcomes in ER/PR positive endometrioid or high-grade serous Ovarian Cancer who have disease progression on second-line chemotherapy, similar to what is seen in breast cancer studies.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nEvidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;\nSubject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;\n18 years of age or older;\nPatient agrees not to participate in another interventional study while on treatment;\nHistology confirmed ovarian cancer serous or endometrioid high degree, fallopian tube or with locoregional recurrence peritoneum (not amenable to curative treatment) or metastatic;\nEstrogen (ER) and/or progesterone (RP) receptor positive tumor, defined as > 10% by immunohistochemical examination in the local laboratory;\nAvailability of tumor sample from the primary tumor or metastasis, fixed in formalin and embedded in paraffin, for confirmation of positivity for ER and/or RP in a central laboratory;\nDisease measurable by RECIST 1.1 as assessed by the local investigator or radiologist;\nPatients must have chemotherapy application for recurrence locoregional or metastatic according to the following criteria:\n\nat least one platinum-based chemotherapy regimen;\nhave confirmed no more than 3 chemotherapy regimens for locally advanced or metastatic disease\nPatient must have radiographic disease progression to last treatment;\nFunctional capacity by the Eastern Cooperative Oncology Group (ECOG) ≤ 2;\nAdequate bone marrow function:\n\nAbsolute neutrophil count (CAN) ≥ 1,500/mm3 (≥ 1.5x109/L)\nPlates ≥ 100,000/mm3 or ≥ 100 x 109/L\nHemoglobin ≥ 9.0 g/dL;\n12. Adequate liver function:\n\nTotal serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 3.0 x ULN if there is Gilbert's Syndrome)\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (≤ 5.0 x ULN if liver tumor was involved)\nAlkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if any liver tumor involvement); 13. Adequate kidney function:\nEstimated creatinine clearance ≥ 15 mL/min; 14. Evidence of lack of potential to become pregnant:\nPost-menopause (defined as at least 1 year without menstruation) before selection, or\nRadiotherapy-induced oophorectomy with the last menstruation > 1 year ago, or\nSurgical sterilization (bilateral oophorectomy or hysterectomy).""}",{'Arm - Disease - Indication': 'PR-Positive ER-Positive Previously Treated Metastatic High Grade Serous Ovarian Cancer\nPR-Positive ER-Positive Previously Treated Metastatic Endometrioid Ovarian Cancer\nPR-Positive ER-Positive Previously Treated Metastatic Fallopian Tube Cancer\nPR-Positive ER-Positive Previously Treated Metastatic Locoregionally Recurrent Peritoneal Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04626791,"{'Official Title': 'A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma', 'Brief Summary': 'This phase II trial investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Modified VR-CAP is a combination of drugs used as standard first line treatment for mantle cell lymphoma. Chemotherapy drugs, such as bortezomib, cyclophosphamide, doxorubicin hydrochloride, and cytarabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that binds and depletes malignant B cells, by inducing immune responses and direct toxicity. Acalabrutinib blocks a key enzyme which is needed for malignant cell growth in mantle cell lymphoma. Combining modified VR-CAP and acalabrutinib as first line therapy may be more useful against mantle cell lymphoma compared to the usual treatment.', 'Condition': 'Mantle Cell Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\r\n\r\nI. To determine the proportion of complete metabolic responses according to Lugano criteria at the end of study therapy.\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To evaluate the safety of this regimen. II. To determine the proportion of subjects proceeding to autologous stem cell transplant (ASCT).\r\n\r\nIII. To determine the feasibility and results of stem cell mobilization and successful collection.\r\n\r\nIV. To determine the progression-free survival (PFS) and overall survival (OS) (event monitoring phase), assessed up to 2 years after registration.\r\n\r\nCORRELATIVE RESEARCH OBJECTIVE:\r\n\r\nI. To assess minimal residual disease level after 3 and 6 cycles of therapy using the ClonoSEQ (Adaptive Biotechnologies, Seattle, Washington [WA]), and to explore the relationship between radiographic complete response (CR) rate and baseline features.\r\n\r\nOUTLINE:\r\n\r\nCYCLES 1, 3, AND 5: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-21. Patients also receive bortezomib subcutaneously (SC) on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) intravenously (IV), cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5.\r\n\r\nCYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2.\r\n\r\nTreatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\r\n\r\nAfter completion of study treatment, patients are followed up every 6 months for up to 2 years after registration.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nAge 18-75 years\r\nNo prior therapy for mantle cell lymphoma (MCL)\r\nMCL in need of systemic therapy, and potentially eligible for ASCT as assessed by the treating physician\r\nDocumented histological confirmation of MCL by local institutional review\r\nDocumented, fludeoxyglucose F-18 (FDG)-avid measurable disease (at least 1 lesion >= 1.5 cm in diameter) as detected by positron emission tomography (PET)/computed tomography (CT) and as defined and includes measurable nodal and extranodal disease sites, or splenomegaly measuring more than 13 cm in vertical length\r\nEastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2\r\nAbsolute neutrophil count (ANC) >= 1000/mm^3 or >= 500/mm^3 if due to lymphomatous marrow or spleen involvement (obtained =< 30 days prior to registration)\r\nPlatelet count >= 100,000/mm^3 or >= 75,000/mm^3 if due to lymphomatous marrow or spleen involvement (obtained =< 30 days prior to registration)\r\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which total bilirubin =< 3 x upper limit of normal [ULN] is permitted) (obtained =< 30 days prior to registration)\r\nAspartate transaminase (AST) =< 3 x ULN (obtained =< 30 days prior to registration)\r\nProthrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) =< 2 x ULN, unless elevated due to a lupus anticoagulant (obtained =< 30 days prior to registration)\r\nCalculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula (obtained =< 30 days prior to registration)\r\nNegative pregnancy test done within =< 14 days prior to registration for women of childbearing potential only\r\nFor women of childbearing potential (WOCBP, defined as premenopausal women capable of becoming pregnant): Must agree to use of highly effective method of birth control during study therapy and until 12 months after last dose of study therapy. NOTE: 'Acceptable' methods are not adequate. Highly effective methods are defined by Clinical Trials Facilitation and Coordination Group [CTFG] as having a failure rate of < 1% per year\r\nMen must agree to use barrier contraception starting with the first dose of study therapy and through 180 days after completion of study therapy\r\nProvide informed written consent\r\nWilling to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\r\nHematologic labs must be obtained within =< 14 days of registration\r\nWilling and able to participate in all required evaluations and procedures in this study protocol\r\nAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information""}",{'Arm - Disease - Indication': 'First-Line Mantle Cell Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03627728,"{'Official Title': 'Phase II Randomized Study of Maintenance Regorafenib vs Placebo in no Progression Patients After First-line Platinum and Fluoropyrimidines Based Chemotherapy in HER2 Negative Locally Advanced/Metastatic Gastric or Gastroesophagel Junction Cancer (a-MANTRA Study)', 'Brief Summary': 'Randomized, double-blind, placebo-controlled, multicenter Phase-II study.\r\n\r\nApproximately 120 subjects with CR/PR/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups:\r\n\r\nArm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale of female ≥ 18 years of age\r\nHave an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment\r\nDiagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\r\nHER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -)\r\nLocally advanced/metastatic gastric or gastroesophageal junction cancer\r\nCR/PR/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy\r\nMeasurable disease according to RECIST 1.1 criteria\r\nHave adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:\r\nTotal bilirubin 1.5 times the upper limit of normal (ULN)\r\nAlanine aminotransferase and aspartate aminotransferase 3 times the ULN\r\nLipase 1.5 times the ULN\r\nSerum creatinine 1.5 times the ULN\r\nGlomerular filtration rate 30 mL/min/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula\r\nInternational normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.\r\nPlatelet count 100,000 /mm3, hemoglobin 9 g/dL, absolute neutrophil count 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors\r\nAlkaline phosphatase ≤ 2.5 times the ULN\r\nUnderstand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure.\r\nIf female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.\r\nIf female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.'}",{'Arm - Disease - Indication': 'Locally advanced metastatic gastric or gastroesophageal junction cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03627728,"{'Official Title': 'Phase II Randomized Study of Maintenance Regorafenib vs Placebo in no Progression Patients After First-line Platinum and Fluoropyrimidines Based Chemotherapy in HER2 Negative Locally Advanced/Metastatic Gastric or Gastroesophagel Junction Cancer (a-MANTRA Study)', 'Brief Summary': 'Randomized, double-blind, placebo-controlled, multicenter Phase-II study.\r\n\r\nApproximately 120 subjects with CR/PR/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups:\r\n\r\nArm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale of female ≥ 18 years of age\r\nHave an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment\r\nDiagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\r\nHER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -)\r\nLocally advanced/metastatic gastric or gastroesophageal junction cancer\r\nCR/PR/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy\r\nMeasurable disease according to RECIST 1.1 criteria\r\nHave adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:\r\nTotal bilirubin 1.5 times the upper limit of normal (ULN)\r\nAlanine aminotransferase and aspartate aminotransferase 3 times the ULN\r\nLipase 1.5 times the ULN\r\nSerum creatinine 1.5 times the ULN\r\nGlomerular filtration rate 30 mL/min/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula\r\nInternational normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.\r\nPlatelet count 100,000 /mm3, hemoglobin 9 g/dL, absolute neutrophil count 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors\r\nAlkaline phosphatase ≤ 2.5 times the ULN\r\nUnderstand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure.\r\nIf female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.\r\nIf female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.'}",{'Arm - Disease - Indication': 'Locally advanced metastatic gastric or gastroesophageal junction cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04590599,"{'Official Title': 'A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy', 'Brief Summary': 'This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy', 'Condition': 'Advanced Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nThe subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.\r\nAged ≥18 years and ≤75 years.\r\nDiagnosed with cervical cancer by histology/cytology.\r\nPatients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).\r\nThe subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue).""}",{'Arm - Disease - Indication': 'Advanced Relapsed or Metastatic Cervical Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04590599,"{'Official Title': 'A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy', 'Brief Summary': 'This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy', 'Condition': 'Advanced Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nThe subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.\r\nAged ≥18 years and ≤75 years.\r\nDiagnosed with cervical cancer by histology/cytology.\r\nPatients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).\r\nThe subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue).""}",{'Arm - Disease - Indication': 'Advanced Relapsed or Metastatic Cervical Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05608785,"{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.\r\n\r\nEvaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.\r\n\r\nRECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).\r\n\r\nPer-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.\r\n\r\nSafety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.\r\n\r\nStatistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.\r\n\r\nSafety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.\r\n\r\nTreatment protocol:\r\n\r\nAll subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.\r\n\r\nGroup 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.\r\n\r\nPrincipal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer\r\nGastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVoluntarily sign the informed consent form for this study.\r\nMale or female patients aged 18-75 years.\r\nunresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.\r\n>6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence\r\nat least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)\r\nECOG score: 0 to 1.\r\nLife expectancy ≥ 3 months.\r\nAdequate organ function, with the following laboratory test values required at screening.\r\nRoutine blood test criteria to be met. Hemoglobin level (HB) ≥ 90 g/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelet count (PLT) ≥100×109/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) ≥4.0×109/L (no granulocyte stimulating factor within 14 days).\r\nBiochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). ALT and AST ≤ 2.5 ULN. Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min, (Cockcroft-Gault formula).\r\nSerum albumin ≥ 25 g/L (2.5 g/dL). For subjects with liver metastases, AST and ALT must be ≤ 5 x ULN, leukocytes ≥ 4 x 109/L, untransfused platelets ≥ 100 x 109/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L\r\n\r\nDoppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).\r\nAdequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.\r\nWomen of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration.\r\nIf local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.'}",{'Arm - Disease - Indication': 'First-Line Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05608785,"{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.\r\n\r\nEvaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.\r\n\r\nRECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).\r\n\r\nPer-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.\r\n\r\nSafety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.\r\n\r\nStatistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.\r\n\r\nSafety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.\r\n\r\nTreatment protocol:\r\n\r\nAll subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.\r\n\r\nGroup 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.\r\n\r\nPrincipal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer\r\nGastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVoluntarily sign the informed consent form for this study.\r\nMale or female patients aged 18-75 years.\r\nunresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.\r\n>6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence\r\nat least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)\r\nECOG score: 0 to 1.\r\nLife expectancy ≥ 3 months.\r\nAdequate organ function, with the following laboratory test values required at screening.\r\nRoutine blood test criteria to be met. Hemoglobin level (HB) ≥ 90 g/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelet count (PLT) ≥100×109/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) ≥4.0×109/L (no granulocyte stimulating factor within 14 days).\r\nBiochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). ALT and AST ≤ 2.5 ULN. Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min, (Cockcroft-Gault formula).\r\nSerum albumin ≥ 25 g/L (2.5 g/dL). For subjects with liver metastases, AST and ALT must be ≤ 5 x ULN, leukocytes ≥ 4 x 109/L, untransfused platelets ≥ 100 x 109/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L\r\n\r\nDoppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).\r\nAdequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.\r\nWomen of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration.\r\nIf local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.'}",{'Arm - Disease - Indication': 'First-Line Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05608785,"{'Official Title': 'Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes', 'Brief Summary': 'Abstract Study title: Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No: GC-MATCH Initiator: Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective: To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advanced/advanced gastric or combined gastroesophageal adenocarcinoma with different gene/protein types.\r\n\r\nEvaluation criteria: To evaluate the adverse effects of drugs using the NCI CTCAE V5.0 criteria.\r\n\r\nRECIST1.1 criteria were used to evaluate drug efficacy Study endpoints: Primary indicators Objective Response Rate (ORR) Secondary indicators 1. drug safety. 2. disease control rate DCR (CR+PR+SD). 3. duration of remission DoR. 4. disease-free survival (PFS) and overall survival time (OS). 5. R0/R1 surgical resection rate Study design: Single-center umbrella clinical trial Planned number of enrollment: Total 39-45 cases Sample size estimation: This is an exploratory study and sample size was not calculated Statistical methods: Selection of data for statistical analysis Full Analysis Set (FAS): The efficacy analysis was performed on all patients who were enrolled and used the drug at least once, according to the principle of intentional analysis (ITT).\r\n\r\nPer-protocol Set: Cases with at least one oncologic efficacy assessment, compliance with the trial protocol, good compliance, no prohibited drugs during the trial, and completion of the case report form.\r\n\r\nSafety Analysis Set: All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set.\r\n\r\nStatistical analysis plan Validity analysis: for the efficacy index PFS, the Kaplan-Meier method will be used to estimate its median time and column Statistical methods: Out of two-sided 95% confidence intervals. Disease control rate (DCR = CR+PR+SD) and objective remission rate (ORR = CR+PR) were calculated using Fisher exact probability and bilateral 95% confidence intervals were presented.\r\n\r\nSafety analysis: descriptive statistical analysis was used to tabulate the AEs that occurred in this trial. laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred.\r\n\r\nTreatment protocol:\r\n\r\nAll subjects in this study were first tested for genes/proteins (HER2 protein, HER2FISH, PD-L1 protein 22C3, Claudin18.2, MMR) and received treatment in different groups according to gene/protein expression.\r\n\r\nGroup 1 HER protein positive 3+ or FISH amplification or HER protein 2+ but FISH amplification Initial treatment (4-6 cycles): IBI315 injection, oxaliplatin, capecitabine Group 2 Claudin18.2 protein-positive Initial treatment (4-6 cycles): PD-L1 monoclonal antibody, TST001 injection, oxaliplatin, capecitabine Group 3 Her protein and Claudin18.2 protein were negative Initial treatment (4-6 cycles): TQB2450 injection, Anrotinib, Oxaliplatin, Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery + local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation. The duration of maintenance treatment was 2 years from the time of enrollment.\r\n\r\nPrincipal Investigator: Luo Suxia, Li Ning Group leader unit: Henan Cancer Hospital', 'Condition': 'Gastric Cancer\r\nGastroesophageal-junction Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVoluntarily sign the informed consent form for this study.\r\nMale or female patients aged 18-75 years.\r\nunresectable advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction (including indolent cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) confirmed by pathological (histological or cytological) examination.\r\n>6 months from the end of prior (neo)adjuvant chemotherapy/adjuvant radiotherapy to the time of disease recurrence\r\nat least one measurable lesion or evaluable lesion according to RECIST version 1.1; measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be optional targets if progression is confirmed and they meet RECIST 1.1 criteria)\r\nECOG score: 0 to 1.\r\nLife expectancy ≥ 3 months.\r\nAdequate organ function, with the following laboratory test values required at screening.\r\nRoutine blood test criteria to be met. Hemoglobin level (HB) ≥ 90 g/L (no blood transfusion within 14 days). Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelet count (PLT) ≥100×109/L (no interleukin 11 or TPO within 14 days). White blood cell count (WBC) ≥4.0×109/L (no granulocyte stimulating factor within 14 days).\r\nBiochemical tests are required to meet the following criteria. Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN). ALT and AST ≤ 2.5 ULN. Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min, (Cockcroft-Gault formula).\r\nSerum albumin ≥ 25 g/L (2.5 g/dL). For subjects with liver metastases, AST and ALT must be ≤ 5 x ULN, leukocytes ≥ 4 x 109/L, untransfused platelets ≥ 100 x 109/L, absolute neutrophil value (ANC) without granulocyte-stimulating factor treatment ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L\r\n\r\nDoppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).\r\nAdequate coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN.\r\nWomen of childbearing potential are required to use highly effective contraception for the duration of the study, and for the period after the last dose and for at least 180 days after chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration; non-sterile men are required to use highly effective contraception for the duration of the study and for at least 180 days after both the last dose and chemotherapy. It is recommended that contraception be initiated at least 3 months prior to study drug administration.\r\nIf local treatment of metastases, such as radiotherapy or ablation, is performed, they may also be enrolled after 14 days of washout as long as an assessable lesion is still present and the local treatment is not followed by anti-tumor therapy such as targeted, chemotherapy or immunotherapy.'}",{'Arm - Disease - Indication': 'First-Line Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03505554,"{'Official Title': 'A Phase 2 Open Label Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma Previously Treated With ALK Inhibitors (CRU3)', 'Brief Summary': 'The purpose of this study is to define the objective response rates (ORR) of Lorlatinib in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.', 'Condition': 'Anaplastic Large Cell Lymphoma, ALK-Positive', 'Detailed Description': 'Lorlatinib is a selective and potent tyrosine kinase inhibitor of ALK and ROS1 that pre-clinically demonstrated dose-dependent inhibition of mutations that confer resistance to other ALK inhibitors; it is also a brain-penetrant thus it might be active in patients with CNS metastases.\r\n\r\nStudy Objectives Primary Define the objective response rates (ORR) of PF-06463922 in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.\r\n\r\nSecondary\r\n\r\nDefine the Progression Free Survival (PFS) in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.\r\nDefine the overall survival (OS) in ALK+ lymphoma patients treated with Lorlatinib, that are resistant or refractory to ALK inhibitors.\r\nDetermine the toxicity profile of Lorlatinib in ALK+ lymphoma patients resistant or refractory to ALK inhibitors.\r\nDetermine the Quality of Life (QoL) in this population of patients using the EORTC-C30 Quality of Life questionnaire.\r\nStudy the mutational status of ALK pre/post Lorlatinib treatment through next-generation sequencing (NGS).\r\nStudy design This is a phase 2 study open to 12 eligible patients with lymphoma with a confirmed ALK rearrangement. All patients must have been pretreated with at least one line of standard cytotoxic chemotherapy and at least one ALK inhibitor and they must have demonstrated progression (regardless of initial response) or resistance on the last treatment.\r\n\r\nThe study begins with a screening period to assess eligibility, up to and including 28 days prior to the first dose of Lorlatinib. Treatment will continue until patient experiences unacceptable toxicity or progressive disease (PD), starts a new anti-cancer therapy or dies.\r\n\r\nThe study will remain open until all patients have completed 3 years from the enrollment.\r\n\r\nStudy treatment Patients will receive an oral administration of Lorlatinib at a dose of 100mg QD. In case of toxicity, it is possible to proceed to a dose reduction (75mg or 50mg QD) or a temporary interruption of Lorlatinib.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nSigned and dated Informed Consent approved by Local Ethical Committee before any protocol-specific screening procedures.\r\nALK+ Lymphoma diagnosed by IHC or FISH.\r\nRefractory disease or relapse after at least one prior chemotherapy regimen (typically a minimum of 6 cycles of CHOP) and at least one ALK inhibitor; presence of measurable disease by physical examination, CT or CT-PET scan.\r\nAny prior antitumor medical treatment or major surgeries must have been completed at least 14 days prior to initiation of study medication. This could not be respected if there is clear evidence of disease progression, manifested as growing pain attributable to the tumour, fever, growing tumour lesions, increasing LDH values. Systemic anti-cancer therapy completed within a minimum of 5 half-lives of study entry.\r\nAble to take oral therapy.\r\nFemale or male, 18 years of age or older.\r\nECOG performance status 0-3.\r\nAdequate organ function as defined by the following criteria:\r\n\r\nSerum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin 1.5 x ULN (except patients with documented Gilbert's syndrome Creatinine ≤ 1.5 x ULN.\r\n\r\nAdequate bone marrow function:\r\n\r\nAbsolute neutrophil count (ANC) ≥ 1000/µL Platelets ≥ 50.000/µL Hemoglobin ≥ 9.0 g/dL The hematological values will not be considered in case of bone marrow involvement.\r\n\r\nWillingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\r\nFemale and male patients who are of childbearing potential must agree to use an effective form of contraception (2 forms of contraception) with their partners throughout participation in this study and for at least 90 days after the last dose of treatment.""}",{'Arm - Disease - Indication': 'Relapsed ALK Positive Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05715840,"{'Official Title': 'A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.', 'Condition': 'Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)', 'Detailed Description': 'The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study.\r\n\r\nThe primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nAge ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study.\r\nHas histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).\r\n(Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI.\r\nHas provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose.\r\nEastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose.\r\nHas a predicted survival period ≥ 3 months assessed by investigators.\r\nAdverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0.\r\nAdequate organ function as defined below:\r\n\r\nBlood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100 ×10^9/L; Hemoglobin (HGB)≥9 g/dL;\r\nSerum biochemical indexs: Serum creatinine ≤1.5 × ULN or >1.5 × ULN with creatinine clearance (CCr) ≥ 60 mL/min; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Patients with Gilbert's syndrome can be up to 3 × ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 X ULN for patients with liver metastases;\r\nCoagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)≤1.5 × ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy).""}","{'Arm - Disease - Indication': 'Recurrent, or Metastatic PD-L1 Positive Cervical Cancer'}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05715840,"{'Official Title': 'A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.', 'Condition': 'Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)', 'Detailed Description': 'The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study.\r\n\r\nThe primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nAge ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study.\r\nHas histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).\r\n(Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI.\r\nHas provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose.\r\nEastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose.\r\nHas a predicted survival period ≥ 3 months assessed by investigators.\r\nAdverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0.\r\nAdequate organ function as defined below:\r\n\r\nBlood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100 ×10^9/L; Hemoglobin (HGB)≥9 g/dL;\r\nSerum biochemical indexs: Serum creatinine ≤1.5 × ULN or >1.5 × ULN with creatinine clearance (CCr) ≥ 60 mL/min; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Patients with Gilbert's syndrome can be up to 3 × ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 X ULN for patients with liver metastases;\r\nCoagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)≤1.5 × ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy).""}","{'Arm - Disease - Indication': 'Recurrent, or Metastatic PD-L1 Positive Cervical Cancer'}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05529667,"{'Official Title': 'An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Safety and Efficacy of INCB054828 in Combination With Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer With FGFs/FGFRs Genetic Aberration.', 'Brief Summary': 'This study was conducted as a second-line treatment of recurrent / progressive gastric cancer patients with FGFs / FGFRs genetic mutations in the Ib / II clinical trial. The maximum maximal tolerated dose (MTD) and 2-phase recommended dose in combination with INCB054828 and paclitaxel (recommended phase II dose, RP2D), and evaluate the safety and clinical efficacy of this combination therapy. This study consists of two steps: Phase 1 is a dose escalation study to determine the maximum tolerated dose and 2-phase recommended dose of weekly paclitaxel and INCB054828 combination therapy, and Phase 2 is the dose escalation study in combination with INCB054828 and paclitaxel Assess safety and tolerability and identify antitumor effects in stomach cancer with FGFs / FGFRs genetic mutations.', 'Condition': 'Fibroblast Growth Factors (FGFs)/Fibroblast Growth Factor Receptors (FGFRs) Genetic Aberration Gastric Cancer, INCB054828, Paclitaxel', 'Detailed Description': 'phase>\r\n\r\n- Approximately 3-12 patients will be enrolled. The dose escalation will be three patients registered for each cohort until the first dose-limiting toxicity appears during the four weeks of treatment and observation. 13.5mg, once a day begins to take. The paclitaxel is administered once a week for three consecutive weeks and then for one week, followed by a total of four weeks in one cycle.\r\n\r\nphase> Phase 2 studies will be extended to a total of 30 patients with a two-phase recommended dose. Patients will be treated until the time of disease progression, intolerable toxicity, rejection of the patient, or withdrawal of consent. In its pre-screening phase, its next generation sequencing (NGS) is performed. Patients with FGFs / FGFRs genetic abnormalities may be enrolled in this study. If a patient has multiple genetic abnormalities, he or she will first be enrolled in a treatment group that targets a rare genetic abnormality. Registered patients will be treated on a continuous basis every four weeks.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients who agreed in writing to the clinical study consent\r\nHistologically or cytologically confirmed advanced gastric adenocarcinoma. Patients must have experienced objective radiological or disease progress with evidence during or after primary therapy with fluoropyrimidine and platinum.\r\nFGFs / FGFRs have genetic variation on NGS.\r\nPatients whose life expectancy is at least 3 months\r\nIf the Eastern Cooperative Oncology Group (ECOG) is 0 or 1\r\nMeasurable or assessable lesion based on RECIST 1.1 scale\r\nMust be swallowed, should be able to take oral medication\r\nPossible long-term function to receive chemotherapy.\r\nPatients receiving anti-HER2 therapy for HER2 negative or HER2-positive primary treatment'}",{'Arm - Disease - Indication': 'Second-Line Progressive or Advanced or Recurrent FGF Aberrated or FGFR Aberrated Gastric Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04269200,"{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\r\n\r\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}",{'Arm - Disease - Indication': 'First-Line Newly Diagnosed Advanced or Recurrent Stage III or Stage IV Endometrial Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04269200,"{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAge ≥18 years at the time of screening and female.\r\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\r\nPatient must have endometrial cancer in one of the following categories:\r\n\r\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\r\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\r\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\r\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\r\nFPPE tumor sample must be available for MMR evaluation.\r\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}",{'Arm - Disease - Indication': 'First-Line Newly Diagnosed Advanced or Recurrent Stage III or Stage IV Endometrial Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04269200,"{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\r\n\r\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}",{'Arm - Disease - Indication': 'First-Line Newly Diagnosed Advanced or Recurrent Stage III or Stage IV Endometrial Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03617679,"{'Official Title': 'A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer', 'Brief Summary': 'This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.', 'Condition': 'Metastatic Endometrial Cancer ', 'Detailed Description': 'This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nProvision to sign and date the consent form.\nStated willingness to comply with all study procedures and be available for the duration of the study.\nBe a female aged 18-89.\nPatients with a primary Stage III/IV or recurrent endometrial cancer.\nPatients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).\nPrimary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.\nPrevious cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.\nPatients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.\nECOG performance status of 0, 1 or 2.\nANC > or = 1500 cells/microliters\nPlatelet count > 100,000 microliters\nHemoglobin > or = 9.0 g/dL\nSerum albumin > or = 2.5 g/dL\nTotal bilirubin ≤ 1.5 x ULN\nAST and ALT ≤ 3.0 x ULN\nSerum Creatinine ≤ 1.5x ULN""}",{'Arm - Disease - Indication': 'First line Primary Stage III/IV or Recurrent Metastatic Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03617679,"{'Official Title': 'A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer', 'Brief Summary': 'This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.', 'Condition': 'Metastatic Endometrial Cancer ', 'Detailed Description': 'This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\r\n\r\nProvision to sign and date the consent form.\r\nStated willingness to comply with all study procedures and be available for the duration of the study.\r\nBe a female aged 18-89.\r\nPatients with a primary Stage III/IV or recurrent endometrial cancer.\r\nPatients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).\r\nPrimary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.\r\nPrevious cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.\r\nPatients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug.\r\nECOG performance status of 0, 1 or 2.\r\nANC > or = 1500 cells/microliters\r\nPlatelet count > 100,000 microliters\r\nHemoglobin > or = 9.0 g/dL\r\nSerum albumin > or = 2.5 g/dL\r\nTotal bilirubin ≤ 1.5 x ULN\r\nAST and ALT ≤ 3.0 x ULN\r\nSerum Creatinine ≤ 1.5x ULN""}",{'Arm - Disease - Indication': 'First line Primary Stage III/IV or Recurrent Metastatic Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05422911,"{'Official Title': 'A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer', 'Brief Summary': 'The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent, uniform across the US and indifferent to race. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.\n\nBut with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, African Americans with prostate cancer fared as well if not better than Caucasians and importantly had better outcomes with abiraterone, an observation needing further exploration as these therapies move up front.', 'Condition': 'Metastatic Cancer\nNeoplasm, Prostate', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nVeterans must meet the following to be eligible to participate:\n\nBe willing and able to provide written informed consent for the trial.\n\nAge ≥18 years of age on day of signing informed consent.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).\n\nHistologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet-cell features, or small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.\n\nHave been receiving or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).\n\nHigh risk for the development of progression of disease/metastasis, defined as (i) a minimum of three rising PSA values (PSA1 < PSA2 < PSA3) at an interval of at least 1 week apart; (ii) a PSA level of 2 ng per milliliter (2 μg/L) or greater; and (iii) a PSA doubling time of 9 months or less during continuous androgen-deprivation therapy (bilateral orchiectomy or treatment with gonadotropin-releasing hormone analogue agonists or antagonists) as calculated with the use of the method of Pound et al.\n\nHas not received abiraterone acetate, enzalutamide, or apalutamide at the time of enrollment.\n\nHave a predicted life expectancy of >12 months.\nFor patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization.\n\nAble to swallow the study drug and comply with study requirements.\n\nLaboratory tests meet minimum safety requirements:\n\nHepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN\nRenal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl\nHematological: Absolute neutrophil count ≥1000/mm3, Platelet count ≥100,000/mm3; Hemoglobin >9 g/dL Note: The presence of metastatic disease as assessed by any modality is not a contraindication for enrollment.'}",{'Arm - Disease - Indication': 'First-Line Castrate-sensitive Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05422911,"{'Official Title': 'A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer', 'Brief Summary': 'The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent, uniform across the US and indifferent to race. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.\r\n\r\nBut with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, African Americans with prostate cancer fared as well if not better than Caucasians and importantly had better outcomes with abiraterone, an observation needing further exploration as these therapies move up front.', 'Condition': 'Metastatic Cancer\nNeoplasm, Prostate', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nVeterans must meet the following to be eligible to participate:\n\nBe willing and able to provide written informed consent for the trial.\n\nAge ≥18 years of age on day of signing informed consent.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).\n\nHistologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet-cell features, or small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.\n\nHave been receiving or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).\n\nHigh risk for the development of progression of disease/metastasis, defined as (i) a minimum of three rising PSA values (PSA1 < PSA2 < PSA3) at an interval of at least 1 week apart; (ii) a PSA level of 2 ng per milliliter (2 μg/L) or greater; and (iii) a PSA doubling time of 9 months or less during continuous androgen-deprivation therapy (bilateral orchiectomy or treatment with gonadotropin-releasing hormone analogue agonists or antagonists) as calculated with the use of the method of Pound et al.\n\nHas not received abiraterone acetate, enzalutamide, or apalutamide at the time of enrollment.\n\nHave a predicted life expectancy of >12 months.\nFor patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization.\n\nAble to swallow the study drug and comply with study requirements.\n\nLaboratory tests meet minimum safety requirements:\n\nHepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN\nRenal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl\nHematological: Absolute neutrophil count ≥1000/mm3, Platelet count ≥100,000/mm3; Hemoglobin >9 g/dL Note: The presence of metastatic disease as assessed by any modality is not a contraindication for enrollment.'}",{'Arm - Disease - Indication': 'First-Line Castrate-sensitive Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04442022,"{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\n\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\nMaintenance therapy will not be counted as a separate line of systemic therapy.\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\nAdequate bone marrow function at screening, defined as:\n\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\nAdequate liver and kidney function, defined as:\n\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\nAn estimated life expectancy of >3 months at Screening.\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}",{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04442022,"{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\r\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\r\n\r\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\r\nMaintenance therapy will not be counted as a separate line of systemic therapy.\r\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\r\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\r\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\r\nAdequate bone marrow function at screening, defined as:\r\n\r\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\r\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\r\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\r\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\r\nAdequate liver and kidney function, defined as:\r\n\r\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\r\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\r\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\r\nAn estimated life expectancy of >3 months at Screening.\r\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\r\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\r\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\r\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}",{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04442022,"{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\r\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\r\n\r\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\r\nMaintenance therapy will not be counted as a separate line of systemic therapy.\r\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\r\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\r\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\r\nAdequate bone marrow function at screening, defined as:\r\n\r\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\r\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\r\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\r\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\r\nAdequate liver and kidney function, defined as:\r\n\r\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\r\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\r\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\r\nAn estimated life expectancy of >3 months at Screening.\r\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\r\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\r\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\r\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}",{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04442022,"{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\r\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\r\n\r\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\r\nMaintenance therapy will not be counted as a separate line of systemic therapy.\r\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\r\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\r\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\r\nAdequate bone marrow function at screening, defined as:\r\n\r\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\r\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\r\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\r\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\r\nAdequate liver and kidney function, defined as:\r\n\r\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\r\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\r\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\r\nAn estimated life expectancy of >3 months at Screening.\r\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\r\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\r\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\r\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}",{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04442022,"{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\r\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\r\n\r\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\r\nMaintenance therapy will not be counted as a separate line of systemic therapy.\r\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\r\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\r\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\r\nAdequate bone marrow function at screening, defined as:\r\n\r\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\r\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\r\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\r\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\r\nAdequate liver and kidney function, defined as:\r\n\r\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\r\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\r\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\r\nAn estimated life expectancy of >3 months at Screening.\r\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\r\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\r\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\r\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}",{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04442022,"{'Official Title': 'A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)', 'Brief Summary': 'The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.', 'Condition': 'Relapsed/Refractory Diffuse Large B-cell Lymphoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHave pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\r\nHave received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\r\n\r\nSalvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\r\nMaintenance therapy will not be counted as a separate line of systemic therapy.\r\nRadiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\r\nPositron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.\r\nNot intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent [%] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\r\nAdequate bone marrow function at screening, defined as:\r\n\r\nAbsolute neutrophil count (ANC) ≥1*10^9 per liter (/L).\r\nPlatelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior to Cycle 1 Day 1 [C1D1]).\r\nHemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).\r\nCirculating lymphocytes less than or equal to (≤) 50*10^9/L.\r\nAdequate liver and kidney function, defined as:\r\n\r\nAspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.\r\nSerum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\r\nCalculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based on Cockcroft-Gault formula.\r\nEastern Cooperative Oncology Group (ECOG) performance status of ≤2.\r\nAn estimated life expectancy of >3 months at Screening.\r\nPatients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\r\nAgree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\r\nFemale patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\r\nMale patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.'}",{'Arm - Disease - Indication': 'Previously Treated Relapsed or Refractory Diffuse Large B-cell Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04934722,"{'Official Title': 'A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)', 'Brief Summary': 'This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).\r\n\r\nAs of Amendment 4, the study is being stopped for futility. All the prespecified interim analyses after interim analysis 1 (IA1) and final analysis of the study described in the statistical analysis plan (SAP) will not be performed. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.', 'Condition': 'Metastatic Hormone-Sensitive Prostate Cancer', 'Detailed Description': 'The China extension study will include participants previously enrolled in China in the global study for MK-3475-991 (NCT04191096) plus those enrolled during the China extension enrollment period. A total of approximately 186 Chinese participants will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\r\nHas metastatic disease assessed by investigator and verified by BICR by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI)\r\nWilling to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy\r\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization\r\nParticipants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization\r\nHas adequate organ function\r\nHas provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample\r\nMale participants must agree to the following during the intervention period and for at least 120 days after the last dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR agree to use contraception, unless confirmed to be azoospermic\r\nMale participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex'}",{'Arm - Disease - Indication': 'Metastatic Hormone-Sensitive Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04934722,"{'Official Title': 'A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)', 'Brief Summary': 'This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).\r\n\r\nAs of Amendment 4, the study is being stopped for futility. All the prespecified interim analyses after interim analysis 1 (IA1) and final analysis of the study described in the statistical analysis plan (SAP) will not be performed. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.', 'Condition': 'Metastatic Hormone-Sensitive Prostate Cancer', 'Detailed Description': 'The China extension study will include participants previously enrolled in China in the global study for MK-3475-991 (NCT04191096) plus those enrolled during the China extension enrollment period. A total of approximately 186 Chinese participants will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\r\nHas metastatic disease assessed by investigator and verified by BICR by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI)\r\nWilling to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy\r\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization\r\nParticipants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization\r\nHas adequate organ function\r\nHas provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample\r\nMale participants must agree to the following during the intervention period and for at least 120 days after the last dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR agree to use contraception, unless confirmed to be azoospermic\r\nMale participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex'}",{'Arm - Disease - Indication': 'Metastatic Hormone-Sensitive Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05201352,"{'Official Title': 'Multicentric Randomized Phase I/II Study to Evaluate Efficacy of Trifluridine/Tipiracil Plus XB2001 (Anti-IL-1α True Human Antibody) Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine', 'Brief Summary': 'Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Recently, trifluridine/tipiracil has also shown efficacy in phase 3 with an overall survival of around 7 months. Trifluridine/tipiracil has become the standard of care for advanced mCRC in most western countries. However, the objective response rate remains very low and the survival gain remains moderate (+2 months). Therefore, new strategies are needed to ensure that mCRC patients who have received multiple lines of therapy can receive more effective treatments.\r\n\r\nBased on previous clinical trials on IL-1 inhibition and our preclinical data, IL-1 inhibition may increase the efficacy of trifluridine/tipiracil. The goal is to test whether the addition of XB2001 to trifluridine/tipiracil could be synergistic.', 'Condition': 'Metastatic Colorectal Cancer', 'Detailed Description': 'This project proposes to evaluate trifluridine/tipiracil plus XB2001 in patients with metastatic colorectal cancer previously treated with oxaliplatin, fluoropyrimidine and irinotecan in combination or not with an anti-angiogenic and an anti-EGFR for RAS Wild type tumor.\r\n\r\nThe project will consist of a randomized (1:1 ratio), double-blind, non-comparative, multi-center Phase II study with two treatment arms:\r\n\r\nExperimental arm: trifluridine/tipiracil + XB2001\r\nControl arm: trifluridine/tipiracil + placebo', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nMale or female that must have signed a written informed consent prior to any study specific procedures\r\nAged ≥ 18 years at randomization\r\nPatient with histologically proven metastatic colorectal cancer previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, fluoropyrimidine, antiangiogenic (anti-VEGF: bevacizumab or aflibercept) and anti-EGFR (cetuximab or panitumumab) if indicated (MSI tumor could be included if previously pretreated with anti PD1/PDL1 therapy)\r\nHave a performance status of 0 or 1 according to the WHO Easter Cooperative Oncology Group (ECOG)\r\nKnowledge of RAS, BRAF, Microsatellite status\r\nBaseline tumoral evaluation (thoraco-abdomino-pelvic computed tomography) perfromed within 21 days before randomization with at least one measurable lesion according to RECIST 1.1 criteria.\r\nPatient willing and able to comply with protocol for the duration of the study including: scheduled visits and exams, visits during the follow-up and treatment compliance.\r\nAdequat hepatic, renal and bone marrow function within the following limits:\r\nTotal bilirubin ≤ 1,5 times the upper limit of normal (ULN) (unless documented Gilbert's syndrome);\r\nASAT et ALAT ≤ 5 times ULN;\r\nMeasured Creatinine clearance (Cockcroft and Gault) > 30 ml / min\r\nAbsolute Neutrophil Count (ANC) > 1,5. 109 / L;\r\nPlatelet count ≥ 150. 109 / L;\r\nHaemoglobin ≥ 9 g / dL (patients can be included even if they have been transfused)\r\nAlbuminemia ≥ 30 g / L;\r\nNegative Hepatitis B, C and HIV serologies, or absence of active B or C hepatitis\r\nUrea protein, urine dipstick should be less than 2 crossese or <1g/kg\r\nAvailability of tumor material dated less than 2 years with sufficient quantity (15 to 20 whithe slides)\r\nPatient must be affiliated to a social health insurance\r\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (urine within 72h or serum pregnancy within 14 days prior to inclusion).\r\nWomen of childbearing potential willing to use adequate contraception method (including the use of a mechanical method of contraception in the event of hormonal contraceptive treatment) during the treatment period and 6 months following the end of treatment.\r\nMale patients with a partner of childbearing potential should use effective contraception during treatment and for up to 6 months after stopping treatment.\r\nNormal ECG or ECG without clinically significant findings with QTc < 470 ms.""}",{'Arm - Disease - Indication': 'Previously Treated Metastatic Colorectal Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05201352,"{'Official Title': 'Multicentric Randomized Phase I/II Study to Evaluate Efficacy of Trifluridine/Tipiracil Plus XB2001 (Anti-IL-1α True Human Antibody) Versus Trifluridine/Tipiracil Plus Placebo in Metastatic Colorectal Cancer Patients After Failure of Oxaliplatin, Irinotecan, Fluoropyrimidine', 'Brief Summary': 'Unresectable metastatic colorectal cancer (mCRC) remains an incurable disease. After failure of conventional treatments involving fluoropyrimidines, oxaliplatin and irinotecan in combination or not with biotherapies targeting EGFR and VEGF; regorafenib shows a modest improvement in overall survival. Recently, trifluridine/tipiracil has also shown efficacy in phase 3 with an overall survival of around 7 months. Trifluridine/tipiracil has become the standard of care for advanced mCRC in most western countries. However, the objective response rate remains very low and the survival gain remains moderate (+2 months). Therefore, new strategies are needed to ensure that mCRC patients who have received multiple lines of therapy can receive more effective treatments.\n\nBased on previous clinical trials on IL-1 inhibition and our preclinical data, IL-1 inhibition may increase the efficacy of trifluridine/tipiracil. The goal is to test whether the addition of XB2001 to trifluridine/tipiracil could be synergistic.', 'Condition': 'Metastatic Colorectal Cancer', 'Detailed Description': 'This project proposes to evaluate trifluridine/tipiracil plus XB2001 in patients with metastatic colorectal cancer previously treated with oxaliplatin, fluoropyrimidine and irinotecan in combination or not with an anti-angiogenic and an anti-EGFR for RAS Wild type tumor.\r\n\r\nThe project will consist of a randomized (1:1 ratio), double-blind, non-comparative, multi-center Phase II study with two treatment arms:\r\n\r\nExperimental arm: trifluridine/tipiracil + XB2001\r\nControl arm: trifluridine/tipiracil + placebo', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nMale or female that must have signed a written informed consent prior to any study specific procedures\r\nAged ≥ 18 years at randomization\r\nPatient with histologically proven metastatic colorectal cancer previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, fluoropyrimidine, antiangiogenic (anti-VEGF: bevacizumab or aflibercept) and anti-EGFR (cetuximab or panitumumab) if indicated (MSI tumor could be included if previously pretreated with anti PD1/PDL1 therapy)\r\nHave a performance status of 0 or 1 according to the WHO Easter Cooperative Oncology Group (ECOG)\r\nKnowledge of RAS, BRAF, Microsatellite status\r\nBaseline tumoral evaluation (thoraco-abdomino-pelvic computed tomography) perfromed within 21 days before randomization with at least one measurable lesion according to RECIST 1.1 criteria.\r\nPatient willing and able to comply with protocol for the duration of the study including: scheduled visits and exams, visits during the follow-up and treatment compliance.\r\nAdequat hepatic, renal and bone marrow function within the following limits:\r\nTotal bilirubin ≤ 1,5 times the upper limit of normal (ULN) (unless documented Gilbert's syndrome);\r\nASAT et ALAT ≤ 5 times ULN;\r\nMeasured Creatinine clearance (Cockcroft and Gault) > 30 ml / min\r\nAbsolute Neutrophil Count (ANC) > 1,5. 109 / L;\r\nPlatelet count ≥ 150. 109 / L;\r\nHaemoglobin ≥ 9 g / dL (patients can be included even if they have been transfused)\r\nAlbuminemia ≥ 30 g / L;\r\nNegative Hepatitis B, C and HIV serologies, or absence of active B or C hepatitis\r\nUrea protein, urine dipstick should be less than 2 crossese or <1g/kg\r\nAvailability of tumor material dated less than 2 years with sufficient quantity (15 to 20 whithe slides)\r\nPatient must be affiliated to a social health insurance\r\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients (urine within 72h or serum pregnancy within 14 days prior to inclusion).\r\nWomen of childbearing potential willing to use adequate contraception method (including the use of a mechanical method of contraception in the event of hormonal contraceptive treatment) during the treatment period and 6 months following the end of treatment.\r\nMale patients with a partner of childbearing potential should use effective contraception during treatment and for up to 6 months after stopping treatment.\r\nNormal ECG or ECG without clinically significant findings with QTc < 470 ms.""}",{'Arm - Disease - Indication': 'Previously Treated Metastatic Colorectal Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03875235,"{'Official Title': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers', 'Brief Summary': 'Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)', 'Condition': 'Biliary Tract Neoplasms', 'Detailed Description': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.\nPatients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.\nPatient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.\nWHO/ECOG PS of 0 or 1'}",{'Arm - Disease - Indication': 'First-Line Previously Untreated Unresectable Advanced or Metastatic Biliary Tract Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03875235,"{'Official Title': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers', 'Brief Summary': 'Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)', 'Condition': 'Biliary Tract Neoplasms', 'Detailed Description': 'A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine Plus Cisplatin Versus Placebo in Combination with Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.\nPatients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.\nPatient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.\nWHO/ECOG PS of 0 or 1'}",{'Arm - Disease - Indication': 'First-Line Previously Untreated Unresectable Advanced or Metastatic Biliary Tract Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01972217,"{'Official Title': 'A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel', 'Brief Summary': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.', 'Condition': 'Metastatic Castration-resistant Prostate Cancer', 'Detailed Description': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and PK of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo-controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo in addition to abiraterone.\r\n\r\nAbiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg bid will be administered with the abiraterone in this study, but throughout this protocol the treatment will be referred to simply as abiraterone.\r\n\r\nFor Part A of the study, 15 to 18 evaluable patients (Cohorts 1 and 2) are planned to be enrolled from approximately 4 sites in approximately 1 or 2 countries, and a further 12 patients may be recruited into a 3rd cohort if necessary.\r\n\r\nFor Part B of the study, approximately 140 patients who have received prior chemotherapy containing docetaxel will be randomised from approximately 40 sites in North America and Europe. Patients who have been dosed in Part A of the study may not participate in Part B.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nProvision of signed and dated written informed consent prior to any study specific procedures.\r\nMale aged 18 years and older.\r\nHistologically or cytologically proven diagnosis of prostate cancer.\r\nCandidate for abiraterone therapy with documented evidence of metastatic castration-resistant prostate cancer. Metastatic status is defined as at least one documented metastatic lesion on either bone scan or CT/MRI scan. Castration resistant prostate cancer is defined as rising PSA or other signs of disease progression despite treatment with androgen deprivation therapy and the presence of a castrate level of testosterone (≤50 ng/dL).\r\nEastern Cooperative Oncology Group (ECOG) performance status 0 to 2 with no deterioration over the previous 2 weeks.\r\nPatients must have a life expectancy ≥12 weeks.\r\nPatients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, and completing PRO instruments.\r\nPatients must be on a stable concomitant medication regimen, defined as no changes in medication or in dose within 2 weeks prior to start of olaparib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least 4 weeks prior to start of olaparib dosing.\r\nFor the randomised phase only, patients must have received chemotherapy in the form of docetaxel treatment for metastatic castration-resistant prostate cancer. Note: patients who discontinued docetaxel for toxicity reasons and without completing the full course will still be eligible to enter this study provided they received at least 2 cycles of chemotherapy.\r\nProvide informed consent for the pharmacogenetic sampling and analyses.'}",{'Arm - Disease - Indication': 'Previously Treated Metastatic Castration-Resistant Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01972217,"{'Official Title': 'A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel', 'Brief Summary': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.', 'Condition': 'Metastatic Castration-resistant Prostate Cancer', 'Detailed Description': 'This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and PK of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo-controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo in addition to abiraterone.\r\n\r\nAbiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg bid will be administered with the abiraterone in this study, but throughout this protocol the treatment will be referred to simply as abiraterone.\r\n\r\nFor Part A of the study, 15 to 18 evaluable patients (Cohorts 1 and 2) are planned to be enrolled from approximately 4 sites in approximately 1 or 2 countries, and a further 12 patients may be recruited into a 3rd cohort if necessary.\r\n\r\nFor Part B of the study, approximately 140 patients who have received prior chemotherapy containing docetaxel will be randomised from approximately 40 sites in North America and Europe. Patients who have been dosed in Part A of the study may not participate in Part B.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nProvision of signed and dated written informed consent prior to any study specific procedures.\r\nMale aged 18 years and older.\r\nHistologically or cytologically proven diagnosis of prostate cancer.\r\nCandidate for abiraterone therapy with documented evidence of metastatic castration-resistant prostate cancer. Metastatic status is defined as at least one documented metastatic lesion on either bone scan or CT/MRI scan. Castration resistant prostate cancer is defined as rising PSA or other signs of disease progression despite treatment with androgen deprivation therapy and the presence of a castrate level of testosterone (≤50 ng/dL).\r\nEastern Cooperative Oncology Group (ECOG) performance status 0 to 2 with no deterioration over the previous 2 weeks.\r\nPatients must have a life expectancy ≥12 weeks.\r\nPatients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations, and completing PRO instruments.\r\nPatients must be on a stable concomitant medication regimen, defined as no changes in medication or in dose within 2 weeks prior to start of olaparib dosing, except for bisphosphonates, denosumab and corticosteroids, which should be stable for at least 4 weeks prior to start of olaparib dosing.\r\nFor the randomised phase only, patients must have received chemotherapy in the form of docetaxel treatment for metastatic castration-resistant prostate cancer. Note: patients who discontinued docetaxel for toxicity reasons and without completing the full course will still be eligible to enter this study provided they received at least 2 cycles of chemotherapy.\r\nProvide informed consent for the pharmacogenetic sampling and analyses.'}",{'Arm - Disease - Indication': 'Previously Treated Metastatic Castration-Resistant Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05797831,"{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}",{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05797831,"{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}",{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05797831,"{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}",{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05797831,"{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}",{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05797831,"{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}",{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05797831,"{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}",{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05797831,"{'Official Title': 'A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy', 'Brief Summary': 'This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.\r\n\r\nThe study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.', 'Condition': 'Endometrial Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nECOG 0-1\r\nHistologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT\r\nSubjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1\r\nAdequate hematologic, hepatic and renal function (within 14 days)'}",{'Arm - Disease - Indication': 'TP53WT Advanced or Recurrent Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01120249,"{'Official Title': 'EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study', 'Brief Summary': 'RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.\r\n\r\nPURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.', 'Condition': 'Kidney Cancer', 'Detailed Description': 'OBJECTIVES:\r\n\r\nPrimary\r\n\r\nto compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy.\r\nSecondary\r\n\r\nTo compare the overall survival of patients treated with everolimus vs placebo.\r\nTo compare qualitative and quantitative toxicity between the two study arms.\r\nTo bank tissue and biologic specimens for future study of molecular biomarkers relevant to the AKT/mTOR and other pathways implicated in the pathogenesis of renal carcinoma and to investigate their potential predictive and prognostic value.\r\nTo bank blood specimens for the future study of the relationship between steady-state trough levels of everolimus and relevant side effects (lymphopenia, infection, hyperglycemia, hypercholesterolemia, hypertriglyceridemia) in patients treated on this study with everolimus.\r\nOUTLINE: This is a multicenter study.\r\n\r\nPatients are stratified according to pathologic stage (intermediate high-risk vs very high-risk), histologic subtype (clear cell vs non-clear cell), and performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.\r\n\r\nArm I: Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.\r\nArm II: Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.\r\nArchived tumor tissue, plasma, and whole blood samples may be collected periodically for biomarker analysis and other translational studies.\r\n\r\nAfter completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 8 years.', 'Inclusion Criteria': 'DISEASE CHARACTERISTICS:\r\n\r\nHistologically or cytologically confirmed renal cell carcinoma\r\n\r\nClear cell or non-clear cell allowed\r\n\r\nNo disease of the collecting duct or medullary carcinoma\r\nConsidered pathologically either intermediate high-risk or very high-risk disease\r\nNo history of distant metastases\r\nPatients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible\r\nHave undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes\r\n\r\nSurgical margins must be negative\r\n\r\nPatients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)\r\nPatients must be registered within 84 days after the date of the first surgical resection of the first tumor\r\nNo evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration\r\n\r\nMRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT scan of the chest may be substituted if the patient is not able to have CT scans with IV contrast\r\nPATIENT CHARACTERISTICS:\r\n\r\nZubrod performance status 0-1\r\nANC ≥ 1,500/mm^3\r\nPlatelet count ≥ 100,000/mm^3\r\nSerum creatinine ≤ 2.0 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 30 mL/min\r\nBilirubin ≤ 1.5 times ULN\r\nSGOT and SGPT ≤ 2.5 times ULN\r\nNot pregnant or nursing\r\nFertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment\r\nAble to take oral medications\r\nPatients must not have any of the following:\r\n\r\nNYHA class III-IV cardiac disease (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort)\r\nUnstable angina pectoris\r\nMyocardial infarction within the past 6 months\r\nSerious uncontrolled cardiac arrhythmia\r\nPatients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)\r\nHBV and HCV testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection\r\nMust be able to take oral medications\r\nNo impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\r\nNo known history of HIV seropositivity\r\nNo known uncontrolled, underlying pulmonary disease (spirometry and DLCO ≤ 50% of predicted OR oxygen saturation ≤ 88% at rest on room air)\r\nNo uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 times ULN) obtained within 28 days prior to registration\r\n\r\nOptimal lipid control must be achieved before registration and monitored during protocol treatment\r\nNo uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 times ULN) obtained within 28 days prior to registration.\r\n\r\nOptimal glucose control must be achieved before registration and monitored during protocol treatment\r\nNo prior malignancies except for any of the following:\r\n\r\nAdequately treated basal cell or squamous cell skin cancer\r\nIn situ cervical cancer\r\nAdequately treated stage I or stage II cancer from which the patient is currently in complete remission\r\nAny other cancer from which the patient has been disease-free for 5 years\r\nNo known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients\r\nNo contraindications to receiving either IV iodine-based contrast or gadolinium\r\nPRIOR CONCURRENT THERAPY:\r\n\r\nSee Disease Characteristics\r\nPatients must have recovered from any surgery-related complications\r\nNo prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy\r\nMore than 14 days since prior and no concurrent strong CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, voriconazole, posaconazole, fluvoxamine, nefazodone, nelfinavir, or ritonavir) or strong CYP3A4 inducers (i.e., phenytoin, rifampin, or rifabutin)\r\nMore than 7 days since prior and no concurrent live vaccines\r\nNo other concurrent anticancer agents including investigational agents\r\nNo concurrent chronic treatment with systemic steroids or another immunosuppressive agent\r\n\r\nTopical or inhaled corticosteroids are allowed'}",{'Arm - Disease - Indication': 'Intermediate high-risk or very high-risk Postoperative Renal Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01120249,"{'Official Title': 'EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study', 'Brief Summary': 'RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.\r\n\r\nPURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.', 'Condition': 'Kidney Cancer', 'Detailed Description': 'OBJECTIVES:\r\n\r\nPrimary\r\n\r\nto compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy.\r\nSecondary\r\n\r\nTo compare the overall survival of patients treated with everolimus vs placebo.\r\nTo compare qualitative and quantitative toxicity between the two study arms.\r\nTo bank tissue and biologic specimens for future study of molecular biomarkers relevant to the AKT/mTOR and other pathways implicated in the pathogenesis of renal carcinoma and to investigate their potential predictive and prognostic value.\r\nTo bank blood specimens for the future study of the relationship between steady-state trough levels of everolimus and relevant side effects (lymphopenia, infection, hyperglycemia, hypercholesterolemia, hypertriglyceridemia) in patients treated on this study with everolimus.\r\nOUTLINE: This is a multicenter study.\r\n\r\nPatients are stratified according to pathologic stage (intermediate high-risk vs very high-risk), histologic subtype (clear cell vs non-clear cell), and performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.\r\n\r\nArm I: Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.\r\nArm II: Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.\r\nArchived tumor tissue, plasma, and whole blood samples may be collected periodically for biomarker analysis and other translational studies.\r\n\r\nAfter completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 8 years.', 'Inclusion Criteria': 'DISEASE CHARACTERISTICS:\r\n\r\nHistologically or cytologically confirmed renal cell carcinoma\r\n\r\nClear cell or non-clear cell allowed\r\n\r\nNo disease of the collecting duct or medullary carcinoma\r\nConsidered pathologically either intermediate high-risk or very high-risk disease\r\nNo history of distant metastases\r\nPatients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible\r\nHave undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes\r\n\r\nSurgical margins must be negative\r\n\r\nPatients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)\r\nPatients must be registered within 84 days after the date of the first surgical resection of the first tumor\r\nNo evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration\r\n\r\nMRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT scan of the chest may be substituted if the patient is not able to have CT scans with IV contrast\r\nPATIENT CHARACTERISTICS:\r\n\r\nZubrod performance status 0-1\r\nANC ≥ 1,500/mm^3\r\nPlatelet count ≥ 100,000/mm^3\r\nSerum creatinine ≤ 2.0 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 30 mL/min\r\nBilirubin ≤ 1.5 times ULN\r\nSGOT and SGPT ≤ 2.5 times ULN\r\nNot pregnant or nursing\r\nFertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment\r\nAble to take oral medications\r\nPatients must not have any of the following:\r\n\r\nNYHA class III-IV cardiac disease (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort)\r\nUnstable angina pectoris\r\nMyocardial infarction within the past 6 months\r\nSerious uncontrolled cardiac arrhythmia\r\nPatients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)\r\nHBV and HCV testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection\r\nMust be able to take oral medications\r\nNo impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\r\nNo known history of HIV seropositivity\r\nNo known uncontrolled, underlying pulmonary disease (spirometry and DLCO ≤ 50% of predicted OR oxygen saturation ≤ 88% at rest on room air)\r\nNo uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 times ULN) obtained within 28 days prior to registration\r\n\r\nOptimal lipid control must be achieved before registration and monitored during protocol treatment\r\nNo uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 times ULN) obtained within 28 days prior to registration.\r\n\r\nOptimal glucose control must be achieved before registration and monitored during protocol treatment\r\nNo prior malignancies except for any of the following:\r\n\r\nAdequately treated basal cell or squamous cell skin cancer\r\nIn situ cervical cancer\r\nAdequately treated stage I or stage II cancer from which the patient is currently in complete remission\r\nAny other cancer from which the patient has been disease-free for 5 years\r\nNo known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients\r\nNo contraindications to receiving either IV iodine-based contrast or gadolinium\r\nPRIOR CONCURRENT THERAPY:\r\n\r\nSee Disease Characteristics\r\nPatients must have recovered from any surgery-related complications\r\nNo prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy\r\nMore than 14 days since prior and no concurrent strong CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, voriconazole, posaconazole, fluvoxamine, nefazodone, nelfinavir, or ritonavir) or strong CYP3A4 inducers (i.e., phenytoin, rifampin, or rifabutin)\r\nMore than 7 days since prior and no concurrent live vaccines\r\nNo other concurrent anticancer agents including investigational agents\r\nNo concurrent chronic treatment with systemic steroids or another immunosuppressive agent\r\n\r\nTopical or inhaled corticosteroids are allowed'}",{'Arm - Disease - Indication': 'Intermediate high-risk or very high-risk Postoperative Renal Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04634877,"{'Official Title': 'A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)', 'Brief Summary': 'The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nHas a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:\r\n\r\nHas undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and\r\nIs at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.\r\nIs disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.\r\nHas not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC).\r\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.\r\nSubmission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants.\r\nHas adequate organ function within 7 days of randomization.""}",{'Arm - Disease - Indication': 'Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04634877,"{'Official Title': 'A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)', 'Brief Summary': 'The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.', 'Condition': 'Endometrial Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nHas a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:\r\n\r\nHas undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and\r\nIs at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.\r\nIs disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.\r\nHas not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC).\r\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.\r\nSubmission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants.\r\nHas adequate organ function within 7 days of randomization.""}",{'Arm - Disease - Indication': 'Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02043678,"{'Official Title': 'A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)', 'Brief Summary': 'To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': 'This study is a phase III multinational, multicenter,randomized, double blind, placebo controlled, study with a randomization allocation ratio of 1:1 (radium-223 dichloride plus abiraterone acetate plus prednisone/prednisolone: placebo plus abiraterone acetate plus prednisone/prednisolone). Until the final overall survival (OS) analysis, the study period consisted of screening / randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and longterm follow-up phases. Up until this point, subjects received study treatment (radium-223 dichloride or placebo in addition to abiraterone acetate plus prednisone / prednisolone for the first 6 cycles followed by abiraterone acetate plus prednisone / prednisolone thereafter) until an on-study SSE occurred (or other withdrawal criteria were met). After the final OS analysis (after implementation of Amendment 7), in order to reduce the burden to study subjects, evaluation of efficacy and exploratory endpoints will be discontinued, except for symptomatic skeletal event (SSE) and OS. Subjects who are discontinued from study treatment will initiate the long-term follow-up period; therefore, active follow-up periods will no longer be applicable. Subjects who are in active follow-up at the time of Amendment 7 is implemented should have the end of active follow-up completed (protocol driven decision) and should be directly transitioned into the extended safety follow-up study. Long term follow-up will continue until the subject dies, is lost to follow-up, withdraws informed consent, actively objects to collection of further data , or is transitioned to the extended safety follow-up study. Subjects will be followed for safety for up to 7 years, which eventually will be completed in this study or in the extended safety follow-up study.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically confirmed adenocarcinoma of the prostate\r\nMale subjects of age ≥ 18 years\r\nProstate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1\r\nTwo or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis\r\nAsymptomatic or mildly symptomatic prostate cancer\r\nSubjects who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment\r\nMaintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L)\r\nEastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1'}",{'Arm - Disease - Indication': 'Asymptomatic or Mild Symptomatic Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer\nSecondary Bone Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02043678,"{'Official Title': 'A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)', 'Brief Summary': 'To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': 'This study is a phase III multinational, multicenter,randomized, double blind, placebo controlled, study with a randomization allocation ratio of 1:1 (radium-223 dichloride plus abiraterone acetate plus prednisone/prednisolone: placebo plus abiraterone acetate plus prednisone/prednisolone). Until the final overall survival (OS) analysis, the study period consisted of screening / randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and longterm follow-up phases. Up until this point, subjects received study treatment (radium-223 dichloride or placebo in addition to abiraterone acetate plus prednisone / prednisolone for the first 6 cycles followed by abiraterone acetate plus prednisone / prednisolone thereafter) until an on-study SSE occurred (or other withdrawal criteria were met). After the final OS analysis (after implementation of Amendment 7), in order to reduce the burden to study subjects, evaluation of efficacy and exploratory endpoints will be discontinued, except for symptomatic skeletal event (SSE) and OS. Subjects who are discontinued from study treatment will initiate the long-term follow-up period; therefore, active follow-up periods will no longer be applicable. Subjects who are in active follow-up at the time of Amendment 7 is implemented should have the end of active follow-up completed (protocol driven decision) and should be directly transitioned into the extended safety follow-up study. Long term follow-up will continue until the subject dies, is lost to follow-up, withdraws informed consent, actively objects to collection of further data , or is transitioned to the extended safety follow-up study. Subjects will be followed for safety for up to 7 years, which eventually will be completed in this study or in the extended safety follow-up study.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically confirmed adenocarcinoma of the prostate\r\nMale subjects of age ≥ 18 years\r\nProstate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1\r\nTwo or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis\r\nAsymptomatic or mildly symptomatic prostate cancer\r\nSubjects who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment\r\nMaintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L)\r\nEastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1'}",{'Arm - Disease - Indication': 'Asymptomatic or Mild Symptomatic Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer\r\nSecondary Bone Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05319249,"{'Official Title': 'Natural Killer Cell Immunotherapy in Combination With PARP-inhibition to Overcome NKG2D Mediated Immune Evasion in Acute Myeloid Leukemia', 'Brief Summary': 'Therapy resistance remains the major obstacle to cure in many types of cancer. In particular in leukemia, therapy resistance depends on leukemic stem cells (LSC) that exhibit inherent therapy resistance to multiple drugs and contribute to overt leukemic relapse. Cellular therapies alone or in combination with other targeted or chemotherapeutic approaches can overcome drug mediated therapy resistance and induce long lasting remissions. Several trials have shown that adoptive transfer of allogeneic NK cells can induce clinical remission in patients with myeloid malignancies. In addition, the antileukemic efficacy of alloreactive NK cells has been shown to facilitate cure after T cell depleted haploidentical stem cell transplantation. Recently, it was demonstrated that absence of NKGD2 ligand expression on leukemic stem cells determines therapy resistance and immune escape towards NK cells in AML. PARP1 inhibitors can induce re-expression of NKG2D ligands. This phase I/II clinical trial will evaluate the combination of NK cell therapy and PARP inhibition by Talazoparib in patients with poor prognosis AML as characterized by Minimal Residual Disease (MRD) or overt relapse with less than 20% bone marrow blasts. The hypothesis that allogeneic NK cell therapy combined with PARP inhibition will increase the response rate (CR/CRi for relapsed/ refractory patients and MRD-response for MRD positive patients) from 35% to 60% will be tested. The co-primary endpoints are i) response to treatment defined as complete remission (CR) for patients with overt leukemia at time of inclusion and MRD decrease >1log10 for patients with rising MRD at time of inclusion as well as ii) safety and feasibility of the protocol. Key secondary endpoints are event free survival and overall survival. Two cohorts will be assessed independently: patients with i) overt leukemia and ii) patients with rising MRD at time of inclusion. Safety and feasibility will be analyzed continuously during the entire trial. The NAKIP-AML trial will analyze efficacy and feasibility of NK cell transplantation together with PARP1 inhibition.', 'Condition': 'Acute Myeloid Leukemia', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients with confirmed diagnosis of AML according to WHO-2016 (Arber, Orazi et al. 2016) (except acute promyelocytic leukemia) with either de novo AML, AML after preceding myelodysplastic or myeloproliferative syndrome (MDS/MPD), and therapy- related AML (t-AML) after previous cytotoxic therapy or radiation are eligible.\r\n\r\nA) Relapsed or Refractory AML with less than 20% bone marrow blasts and less than 20% blasts in peripheral blood.\r\n\r\nB) Rising MRD levels (>3 fold) as detected by either molecular genetics or flow cytometry in patients still in hematologic remission.\r\n\r\nPatients who received at least one line of AML therapy. This is defined as either stem cell transplantation or intensive AML therapy or palliative AML therapy containing at least one of the following drugs Azacitidine, Decitabine, Cytarabine, Venetoclax or an FLT3 inhibitor..\r\nDiscontinuation of prior AML treatment before the start of study treatment for at least 107 days for cytotoxic agents and ≥ 53 half-lives for non-cytotoxic / investigational drug treatment preceding the first dose of trial medications.\r\nAge ≥ 18 years\r\nECOG ≤2\r\nPregnancy and childbearing potential:\r\n\r\nNon-pregnant and non-nursing women of childbearing potential must have a negative serum or urine ß-HCG pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration. (""Women of childbearing potential"" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months).\r\nFemale patients of reproductive age must agree to avoid getting pregnant while on therapy.\r\nWomen of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin highly effective methods (referring to recommendation of the CTFG) of birth control during study and at least 6 months (women), after end of treatment.\r\nMen must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid to father a child during study and until 6 months after end of treatment.\r\nWillingness of patients to adhere to protocol specific requirements and capacity to give written informed consent\r\nAbility of patient to understand the character and individual consequences of clinical trial\r\nFollowing receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.\r\nSuitable donor for NK cell transplantation'}",{'Arm - Disease - Indication': 'Relapsed or Refractory Acute Myeloid Leukemia'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01068249,"{'Official Title': 'A Phase II Study of Letrozole and RAD001 (Everolimus) in Patients With Advanced or Recurrent Endometrial Cancer', 'Brief Summary': 'The goal of this clinical research study is to learn if the combination of RAD001 (everolimus) and Femara (letrozole) can help to control recurrent or progressive endometrial cancer. The safety of this drug combination will also be studied.', 'Condition': 'Endometrial Cancer', 'Detailed Description': 'The Study Drugs:\r\n\r\nEverolimus is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.\r\n\r\nLetrozole is designed to block chemical pathways that are necessary for tumor growth.\r\n\r\nStudy Drug Administration:\r\n\r\nIf you are found to be eligible to take part in this study, you will take 2 pills of everolimus by mouth 1 time every day. You should not open everolimus until you are about to take it because it absorbs moisture and is sensitive to light. You will also take 1 pill of letrozole by mouth 1 time every day. You should take letrozole at the same time as everolimus.\r\n\r\nEverolimus should be taken the same time every day on an empty stomach (fasting state) or after no more than a light, fat-free meal. You should wait at least 6 hours after a eating a regular (not fat-free meal) before taking everolimus. You should not eat fatty foods for at least 1 hour after taking everolimus.\r\n\r\nIf you cannot swallow the tablets, the tablets should be dissolved in a glass of about 2 tablespoons of water just before being taken. The tablets should then be stirred gently (for a maximum of 7 minutes) until the tablets are dissolved. The contents should then be drunk. If you vomit after taking the study drug, you should not take another tablet that day. If you forgot to take the drug one day, you should not take an extra dose the next day but instead contact your doctor for advice.\r\n\r\nYou will be given a diary where you will record the pills you take each day. You must bring this diary to each visit.\r\n\r\nWhile you are on study, you should avoid grapefruit, grapefruit juice, and other products containing grapefruit. There are also certain drugs you cannot take during this study. You should not take any drugs during the study without asking the study doctor first.\r\n\r\nStudy Visits:\r\n\r\nEvery 4 weeks, the following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including measurement of your weight and vital signs (blood pressure, heart rate, breathing rate, and temperature).\r\nYour performance status will be recorded.\r\nBlood (about 2 tablespoons) will be drawn for routine tests, including checking your liver and kidneys and measuring the levels of sugar in your blood, and levels of fat in your blood.\r\nYou will asked about any side effects you have experienced.\r\nIf the disease is in the pelvis, you will have a pelvic exam.\r\nIf the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn for hepatitis testing.\r\nYour pills will be counted.\r\nAt Week 8, the following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including a pelvic exam.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nAny tumors will be measured. The doctor will either feel the tumor or a CT, x-ray, and/or MRI will be used.\r\nIf the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\nYou will asked about any side effects you have experienced.\r\nAfter the Week 8 Visit, you will have the following tests and procedures. (If the disease has partially or completely responded to the study drugs, these tests will be done around Week 12. If the disease is stable, these tests will be done around Week 16.)\r\n\r\nYou will have a physical exam.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nAny tumors will be measured. The doctor will either feel the tumor or a CT scan, x-ray, and/or MRI will be used.\r\nIf the disease is in your chest, you will have a chest CT and/or MRI scan to check the status of the disease.\r\nAfter the Week 12 or 16 visit, every 12 weeks, the following tests and procedures will be performed:\r\n\r\nYou will have a pelvic exam.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nI-f the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\n\r\nLength of Study:\r\n\r\nYou may continue receiving additional cycles of study treatment. You will be taken off study if you experience intolerable side effects, the disease gets worse, the disease completely responds, or the doctor thinks it is in your best interest.\r\n\r\nEnd of Treatment Visit:\r\n\r\nWithin 4 weeks after the last dose of study drugs, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including measurement of your weight and vital signs.\r\nYou will have a pelvic exam.\r\nYour performance status will be recorded.\r\nBlood (about 2 tablespoons) will be drawn for routine tests, including checking your liver and kidneys and measuring the levels of sugar in your blood, and levels of fat in your blood.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nIf the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\nYour pills will be counted and any unused study drug will be returned.\r\nLong Term Follow-up:\r\n\r\nAfter you are off study, you will be followed by your doctor on a regular basis. How often these visits occur are up to you and your doctor. The following tests and procedures will be performed:\r\n\r\nYou will have a physical exam, including measurement of your weight and vital signs.\r\nYou will have a pelvic exam.\r\nYour performance status will be recorded.\r\nYou will be asked if you have experienced any intolerable side effects.\r\nYou will have a CT and/or MRI scan of your chest, abdomen, and pelvis. Other areas will be scanned if the doctor thinks it is needed.\r\nIf the disease is in your chest, you will have chest CT and/or MRI scan to check the status of the disease.\r\nThis is an investigational study. Everolimus is not FDA approved or commercially available. At this time, everolimus is only being used in research. Letrozole is FDA approved and commercially available for the treatment of breast cancer and ovarian cancer. The combination of everolimus and letrozole in this study for the treatment of endometrial cancer is also investigational. Up to 42 patients will take part in the multicenter study. Up to 42 will be enrolled at MD Anderson.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients must have signed an approved informed consent.\r\nHistologically confirmed endometrial cancer (endometrioid, serous, or clear cell, or mixed histology; any grade) which is considered progressive or recurrent.\r\nPatients may have failed no more than two prior chemotherapeutic regimens for recurrent or advanced disease (including adjuvant therapy). Chemotherapy administered in conjunction with radiation as a radio-sensitizer is not counted as a prior treatment for recurrent or advanced disease.\r\nAll patients must have measurable disease as defined by RECIST 1.1.\r\nPatients must have at least one ""target lesion"" to be used to assess response on this protocol as defined by RECIST. Tumors within a previously irradiated field will be designated as ""non-target"" lesions, unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.\r\nPatients must have a Zubrod performance status of 0, 1, or 2.\r\nPatients must not be of child bearing potential. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal for greater than 12 months. Patients in whom ovaries are present and were not previously menopausal at the time of hysterectomy, should have a serum estradiol < 10 pg/mL to confirm ovarian senescence.\r\nPatients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of >1,500/Fl, a hemoglobin level of >/=9gm/dL and a platelet count of >100,000/Fl. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.\r\nPatients must have an adequate renal function of >50cc/min as documented by the Cockcroft Gault creatinine clearance formula: Estimated GFR = (140 - age) x (weight kg) divided by 72 x serum Creatinine (non-IDMS) x 0.85 (female)\r\nPatients must have adequate hepatic function as documented by a serum bilirubin /= 18 years of age.'}",{'Arm - Disease - Indication': 'Advanced or Recurrent or Progressive Endometrial Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05260671,"{'Official Title': 'An Exploratory Clinical Study to Evaluate the Efficacy and Safety of Penpulimab in Combination With Cetuximab as First-line Treatment in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/MSCCHN)', 'Brief Summary': 'This trial is a multicenter, prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of Penpulimab injection combined with cetuximab in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck', 'Condition': 'Head and Neck Neoplasms\r\nRecurrent Disease\r\nMetastatic Cancer', 'Detailed Description': ""Based on the apparent efficacy and favorable safety profile of previous PD-1 and cetuximab combination therapy, Penpulimab (PD-1 antibody) combined with cetuximab in the first-line treatment of patients with recurrent/metastatic SCCHN are used to assess the efficacy and safety of the regimen. Among them, Penpulimab (PD-1 antibody) is approved for adult patients with relapsed or refractory classical Hodgkin's lymphoma who have received at least second-line systemic chemotherapy in China. Cetuximab is approved in China for first-line treatment of recurrent/metastatic SCCHN in combination with chemotherapeutic drugs platinum and fluorouracil.\r\n\r\nThis study plans to enroll 48 patients with untreated recurrent/metastatic squamous cell carcinoma of the head and neck who will receive Penpulimab injection combined with cetuximab. Cetuximab 500 mg/m2 without PD-1 drugs for 14 days prior to Cycle 1. Cetuximab Injection 500 mg/m2 and Penpulimab Injection 200 mg are intravenously infused on Day 1 (D1) of Cycle 1, with 2 weeks (14 days) as a cycle. Penpulimab will be administered for no more than 96 weeks (48 cycles), and cetuximab will be administered until disease progression, unacceptable toxicity, or withdrawal decision by the subject."", 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nAge: ≥ 18 years, male or female;\r\nHistologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx) (SCCHN);\r\nRecurrent/metastatic SCCHN not suitable for local treatment such as surgery or radiotherapy in the opinion of the investigator;\r\nAt least one measurable tumor lesion according to RECIST 1.1 criteria;\r\nThe tumor expresses PD-L1, with a comprehensive positive score CPS ≥ 1;\r\nEastern Cooperative Oncology Group (ECOG) PS: 0-1\r\nExpected survival ≥ 3 months;\r\nNormal function of major organs, meeting the following criteria: blood routine examination criteria must be met: (no blood transfusion within 14 days before screening) 1) HB ≥ 90 g/L; 2) ANC ≥ 1.5 × 109/L; 3) PLT ≥ 75 × 109/L; biochemistry: (without transfusion or blood product within 14 days before screening) 1) BIL ≤ 1.5 × upper limit of normal (ULN) (≤ 3 × ULN for patients with Gilbert's syndrome); 2) ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); 3) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50ml/min (Cockcroft-Gault formula); 4) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; left ventricular ejection fraction (LVEF) ≥ 50% assessed by cardiac Doppler ultrasound;\r\nWomen of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and are willing to use reliable contraception during the trial and must be non-lactating patients; male subjects must use reliable contraception from the start of treatment to 6 months after the last dose;\r\nThe subjects voluntarily join the study, sign the ICF, have good compliance, and cooperate in the follow-up""}",{'Arm - Disease - Indication': 'recurrent/metastatic squamous cell carcinoma of the head and neck'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05385068,"{'Official Title': 'An Open-label, Single-arm, Phase II Study to Investigate the Efficacy and Safety of Niraparib Combined With Anlotinib Maintenance Retreatment in PSR Ovarian Cancer Patients, Who Have Previously Received PARPi Maintenance Treatment.', 'Brief Summary': 'This study will be an open-label, single-arm, prospective, exploratory phase II trial to investigate the efficacy and safety of niraparib maintenance retreatment in platinum- sensitive recurrent (PSR) epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer).', 'Condition': 'Epithelial Ovarian Cancer', 'Detailed Description': ""This study will investigate the efficacy and safety of niraparib maintenance re-treatment in patients with PSR non-mucinous EOC, who have previously received maintenance therapy with a Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerisation inhibitor (PARPi) and a complete or partial radiological response to subsequent treatment with platinum-based chemotherapy or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy). Patients will be enrolled, given niraparib and anlotinib maintenance treatment until disease progression or untolerated toxicity."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nProvision of informed consent prior to any study specific procedures.\nFemale patients ≥18 years of age, with histologically diagnosed platinum sensitive recurrent high-grade serous or endometrioid epithelial ovarian cancer (EOC) (including primary peritoneal and/or fallopian tube cancer).\nBRCA mutation status is known.\nPatients must have received one prior PARPi therapy, PARPi therapy includes any agent (including niraparib) used in a maintenance setting and the duration of maintenance treatment ≥6 months.\nPatients had received ≤3 lines of chemotherapy, the time between the penultimate line of platinum-containing chemotherapy and the last platinum-containing chemotherapy was > 6 months. For example, if a patient receives a non-platinum type of chemotherapy between the penultimate line of platinum-containing chemotherapy and the last platinum-containing chemotherapy, patient will be eligible if all the eligibility criteria are met.\nThe most recent round of platinum-containing chemotherapy should have included ≥4 cycles of treatment , in the opinion of the investigator, in response (partial or complete radiological response) or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy) .\nPatients must have either CA-125 in the normal range or CA-125 decrease by more than 90% during last line chemotherapy and that is stable for at least 7 days (ie, no increase > 15% from nadir).\nPatients can have received bevacizumab during this course of treatment. Bevacizumab use as part of an earlier line of therapy is permitted.\nPatients must be enrolled within 8 weeks of their last dose of chemotherapy (last dose is the day of the last infusion).\nPatients must have a life expectancy ≥4 months.\nEastern Cooperative Oncology Group performance status 0-2.\nPatients must have normal organ and bone marrow function, defined as follows: Absolute neutrophil count ≥ 1,500/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 10 g/dL; Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault equation; Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN; Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN\nNegative serum or urine pregnancy test prior to receiving the first dose of study treatment and willing to use adequate contraception to prevent pregnancy or must agree to abstain from heterosexual activity throughout the study, starting with enrollment through 90 days after the last dose of study treatment; or women of with no potential fertility.\nAbility to comply with protocol.\nAll of the adverse events caused by chemotherapy recovered to Common Terminology Criteria Adverse Events (CTCAE) grade 1 or baseline, except for stable sensory neuropathy or hair loss ≤ CTCAE grade 2.'}",{'Arm - Disease - Indication': 'Previously Treated Platinum-Sensitive Recurrent Ovarian Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04224493,"{'Official Title': 'Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma\n', 'Brief Summary': ""The participants of this study would have relapsed/refractory follicular lymphoma.\r\n\r\nFollicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after treatment and 'refractory' when treatment no longer works.\r\n\r\nStage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3.\r\n\r\nStage 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combinatio"", 'Condition': 'Relapsed/Refractory Follicular Lymphoma', 'Detailed Description': 'Stage 1 is a safety run-in phase, stage 2 is an efficacy and safety phase for an assessment of the EZH2 Mutant Type population and overall FL population regardless of EZH2 mutation status, and optional stage 3 with efficacy and safety phase for subjects with EZH2 mutation. Stage 3 with Mutant Type population alone will be executed in case the efficacy of the overall population in stage 2 fails whilst the efficacy of EZH2 Mutant Type is sufficiently promising. Stage 2 will include 2 futility interim analyses based on ORR for the first futility and PFS for the second one. In addition, there is a possible sample size re-estimation based on PFS. This is to ensure early detection of the presence/absence of clinical efficacy benefit as well as ensuring adequate powering based on the trial results to demonstrate a meaningful efficacy difference.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nHave voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.\r\nMales or females are ≥18 years of age (≥20 years for Taiwan) at the time of providing voluntary written informed consent.\r\nLife expectancy ≥3 months before enrollment.\r\nSubjects with a history of hepatitis B or C are eligible on the condition that subjects have adequate liver function as defined by Inclusion Criterion #15 but with normal ALT and are hepatitis B surface antigen negative with undetectable HBV DNA and/or have undetectable hepatitis C virus (HCV) RNA if HCV antibody positive.\r\nHave histologically confirmed FL, Grades 1 to 3A.\r\nMust have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:\r\n\r\na. Systemic therapy includes treatments such as:\r\n\r\ni. Rituximab monotherapy\r\n\r\nii. Chemotherapy given with or without rituximab\r\n\r\niii. Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab.\r\n\r\nb. Systemic therapy does not include, for example:\r\n\r\ni. Local involved field radiotherapy for limited-stage disease\r\n\r\nii. Helicobacter pylori eradication\r\n\r\nc. Prior investigational therapies will be allowed provided the subject has received at least 1 prior systemic therapy as discussed in Inclusion Criterion #6a.\r\n\r\nd. Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed.\r\n\r\ne. Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed.\r\n\r\nMust have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression <6 months after last dose).\r\nHave measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).\r\nEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\r\nFor subjects who have experienced any clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy):\r\n\r\na. At the time the subject provides voluntary written informed consent, all toxicities have either resolved to Grade 1 per National Cancer Institute CTCAE Version 5.0 OR are clinically stable and no longer clinically significant.\r\n\r\nHave provided sufficient tumor tissue for EZH2 mutation testing in all subjects to allow for stratification and for CNG determination in a subset of WT EZH2 subjects from the Phase 3 portion of the study.\r\n\r\na. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled, but additional tumor tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than 15 months prior to administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections mounted on slides are also acceptable.\r\n\r\nNOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor's or Designee Medical Monitor.\r\n\r\nTime between prior anticancer therapy and first dose of tazemetostat as follows:\r\n\r\nCytotoxic chemotherapy - At least 21 days.\r\nNoncytotoxic chemotherapy (eg, small molecule inhibitor) - At least 14 days.\r\nNitrosoureas - At least 6 weeks.\r\nMonoclonal and/or bispecific antibodies or CAR T - At least 28 days.\r\nRadiotherapy - At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.\r\nAdequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula.\r\nAdequate bone marrow function:\r\n\r\na. Absolute neutrophil count (ANC) ≥1000/mm3 (≥1.0 × 10^9/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥75 × 10^9/L) with bone marrow infiltration\r\n\r\nWithout growth factor support (filgrastim or pegfilgrastim) for at least 14 days.\r\n\r\nb. Platelets ≥75,000/mm3 (≥75 × 10^9/L)\r\n\r\nEvaluated at least 7 days after last platelet transfusion.\r\n\r\nc. Hemoglobin ≥9.0 g/dL\r\n\r\nMay receive transfusion\r\nAdequate liver function:\r\n\r\nTotal bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.\r\nAlkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver metastases).\r\nInternational normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended.\r\nFemales of childbearing potential (FCBP) must have two negative urine or serum pregnancy tests (beta-human chorionic gonadotropin [β-hCG] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening prior to dosing. The first pregnancy test must be performed within 10 to 14 days prior to first dose of study drug and the second pregnancy test must be performed within 24 hours prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of these pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic [amenorrhea following cancer therapy does not rule out childbearing potential] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing).\r\nFemales of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception:\r\n\r\nExamples of highly effective methods:\r\n\r\nIntrauterine device (IUD)\r\nHormonal (ovulation inhibitory combined [estrogen and progesterone] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrel-releasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel]) NOTE: There is a potential for tazemetostat interference with hormonal contraception methods due to enzymatic induction.\r\nBilateral tubal ligation\r\nPartner's vasectomy (if medically confirmed [azoospermia] and sole sexual partner).\r\nExamples of additional effective methods:\r\n\r\nMale latex or synthetic condom,\r\nDiaphragm,\r\nCervical Cap\r\nNOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.\r\n\r\nAll study participants enrolled must be registered into the mandatory Revlimid REMS™ program for the US or Revlimid Global PPP for ex-US and be willing and able to comply with the requirements of the Revlimid REMS™ or Revlimid Global PPP program as appropriate for the country in which the drug is being used.\r\n\r\na. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS™ program (for the US) or Revlimid Global PPP (for ex-US). During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, and at days 14 and 28 following the last dose of lenalidomide. Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR have had a total hysterectomy and/or bilateral oophorectomy.\r\n\r\nMale subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.\r\nNOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.""}",{'Arm - Disease - Indication': 'Previously Treated Relapsed/\u200bRefractory Follicular Lymphoma '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04224493,"{'Official Title': 'Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma\r', 'Brief Summary': ""The participants of this study would have relapsed/refractory follicular lymphoma.\r\n\r\nFollicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after treatment and 'refractory' when treatment no longer works.\r\n\r\nStage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3.\r\n\r\nStage 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combinatio"", 'Condition': 'Relapsed/Refractory Follicular Lymphoma', 'Detailed Description': 'Stage 1 is a safety run-in phase, stage 2 is an efficacy and safety phase for an assessment of the EZH2 Mutant Type population and overall FL population regardless of EZH2 mutation status, and optional stage 3 with efficacy and safety phase for subjects with EZH2 mutation. Stage 3 with Mutant Type population alone will be executed in case the efficacy of the overall population in stage 2 fails whilst the efficacy of EZH2 Mutant Type is sufficiently promising. Stage 2 will include 2 futility interim analyses based on ORR for the first futility and PFS for the second one. In addition, there is a possible sample size re-estimation based on PFS. This is to ensure early detection of the presence/absence of clinical efficacy benefit as well as ensuring adequate powering based on the trial results to demonstrate a meaningful efficacy difference.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nHave voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.\r\nMales or females are ≥18 years of age (≥20 years for Taiwan) at the time of providing voluntary written informed consent.\r\nLife expectancy ≥3 months before enrollment.\r\nSubjects with a history of hepatitis B or C are eligible on the condition that subjects have adequate liver function as defined by Inclusion Criterion #15 but with normal ALT and are hepatitis B surface antigen negative with undetectable HBV DNA and/or have undetectable hepatitis C virus (HCV) RNA if HCV antibody positive.\r\nHave histologically confirmed FL, Grades 1 to 3A.\r\nMust have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:\r\n\r\na. Systemic therapy includes treatments such as:\r\n\r\ni. Rituximab monotherapy\r\n\r\nii. Chemotherapy given with or without rituximab\r\n\r\niii. Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab.\r\n\r\nb. Systemic therapy does not include, for example:\r\n\r\ni. Local involved field radiotherapy for limited-stage disease\r\n\r\nii. Helicobacter pylori eradication\r\n\r\nc. Prior investigational therapies will be allowed provided the subject has received at least 1 prior systemic therapy as discussed in Inclusion Criterion #6a.\r\n\r\nd. Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed.\r\n\r\ne. Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed.\r\n\r\nMust have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression <6 months after last dose).\r\nHave measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).\r\nEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\r\nFor subjects who have experienced any clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy):\r\n\r\na. At the time the subject provides voluntary written informed consent, all toxicities have either resolved to Grade 1 per National Cancer Institute CTCAE Version 5.0 OR are clinically stable and no longer clinically significant.\r\n\r\nHave provided sufficient tumor tissue for EZH2 mutation testing in all subjects to allow for stratification and for CNG determination in a subset of WT EZH2 subjects from the Phase 3 portion of the study.\r\n\r\na. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled, but additional tumor tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than 15 months prior to administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections mounted on slides are also acceptable.\r\n\r\nNOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor's or Designee Medical Monitor.\r\n\r\nTime between prior anticancer therapy and first dose of tazemetostat as follows:\r\n\r\nCytotoxic chemotherapy - At least 21 days.\r\nNoncytotoxic chemotherapy (eg, small molecule inhibitor) - At least 14 days.\r\nNitrosoureas - At least 6 weeks.\r\nMonoclonal and/or bispecific antibodies or CAR T - At least 28 days.\r\nRadiotherapy - At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.\r\nAdequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula.\r\nAdequate bone marrow function:\r\n\r\na. Absolute neutrophil count (ANC) ≥1000/mm3 (≥1.0 × 10^9/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥75 × 10^9/L) with bone marrow infiltration\r\n\r\nWithout growth factor support (filgrastim or pegfilgrastim) for at least 14 days.\r\n\r\nb. Platelets ≥75,000/mm3 (≥75 × 10^9/L)\r\n\r\nEvaluated at least 7 days after last platelet transfusion.\r\n\r\nc. Hemoglobin ≥9.0 g/dL\r\n\r\nMay receive transfusion\r\nAdequate liver function:\r\n\r\nTotal bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.\r\nAlkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver metastases).\r\nInternational normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended.\r\nFemales of childbearing potential (FCBP) must have two negative urine or serum pregnancy tests (beta-human chorionic gonadotropin [β-hCG] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening prior to dosing. The first pregnancy test must be performed within 10 to 14 days prior to first dose of study drug and the second pregnancy test must be performed within 24 hours prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of these pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic [amenorrhea following cancer therapy does not rule out childbearing potential] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing).\r\nFemales of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception:\r\n\r\nExamples of highly effective methods:\r\n\r\nIntrauterine device (IUD)\r\nHormonal (ovulation inhibitory combined [estrogen and progesterone] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrel-releasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel]) NOTE: There is a potential for tazemetostat interference with hormonal contraception methods due to enzymatic induction.\r\nBilateral tubal ligation\r\nPartner's vasectomy (if medically confirmed [azoospermia] and sole sexual partner).\r\nExamples of additional effective methods:\r\n\r\nMale latex or synthetic condom,\r\nDiaphragm,\r\nCervical Cap\r\nNOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.\r\n\r\nAll study participants enrolled must be registered into the mandatory Revlimid REMS™ program for the US or Revlimid Global PPP for ex-US and be willing and able to comply with the requirements of the Revlimid REMS™ or Revlimid Global PPP program as appropriate for the country in which the drug is being used.\r\n\r\na. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS™ program (for the US) or Revlimid Global PPP (for ex-US). During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, and at days 14 and 28 following the last dose of lenalidomide. Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR have had a total hysterectomy and/or bilateral oophorectomy.\r\n\r\nMale subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.\r\nNOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.""}",{'Arm - Disease - Indication': 'Previously Treated Relapsed/\u200bRefractory Follicular Lymphoma '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03400332,"{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}",{'Arm - Disease - Indication': 'Advanced Metastatic Recurrent and/or Unresectable Solid Tumor'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03400332,"{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}",{'Arm - Disease - Indication': 'Advanced Metastatic Recurrent and/or Unresectable Solid Tumor'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03400332,"{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}",{'Arm - Disease - Indication': 'Advanced Metastatic Recurrent and/or Unresectable Solid Tumor'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03400332,"{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}",{'Arm - Disease - Indication': 'Advanced Metastatic Recurrent and/or Unresectable Solid Tumor'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03400332,"{'Official Title': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'Brief Summary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.', 'Condition': 'Cancer\r\nMelanoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\nAt least 1 lesion accessible for biopsy\r\nEastern Cooperative Oncology Group Performance Status of 0 or 1'}",{'Arm - Disease - Indication': 'Advanced Metastatic Recurrent and/or Unresectable Solid Tumor'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03924869,"{'Official Title': 'A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).\r\n\r\nThe primary study hypotheses are:\r\n\r\nSBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and\r\nSBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nHas previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded\r\nCannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented\r\nHas a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\r\nIs able to receive SBRT and does not have an ultra-centrally located tumor\r\nHas adequate organ function within 7 days prior to the start of study treatment\r\nA female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose\r\nMale participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic\r\nHas a radiation therapy plan approved by the central radiation therapy quality assurance vendor""}",{'Arm - Disease - Indication': 'Adult Previously Untreated Unresected Stage I or Stage II Non-Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03924869,"{'Official Title': 'A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).\r\n\r\nThe primary study hypotheses are:\r\n\r\nSBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and\r\nSBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nHas previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded\r\nCannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented\r\nHas a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\r\nIs able to receive SBRT and does not have an ultra-centrally located tumor\r\nHas adequate organ function within 7 days prior to the start of study treatment\r\nA female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose\r\nMale participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic\r\nHas a radiation therapy plan approved by the central radiation therapy quality assurance vendor""}",{'Arm - Disease - Indication': 'Adult Previously Untreated Unresected Stage I or Stage II Non-Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02667587,"{'Official Title': 'A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma', 'Brief Summary': 'The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.', 'Condition': 'Brain Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nMales and Females, age ≥ 18 years old\nNewly diagnosed brain cancer or tumor called glioblastoma or GBM\nKarnofsky performance status of ≥ 70 (able to take care of self)\nSubstantial recovery from surgery resection\nTumor test result shows MGMT methylated or indeterminate tumor subtype'}",{'Arm - Disease - Indication': 'Newly Diagnosed Adult MGMT-Methylated Glioblastoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02667587,"{'Official Title': 'A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma', 'Brief Summary': 'The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.', 'Condition': 'Brain Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMales and Females, age ≥ 18 years old\r\nNewly diagnosed brain cancer or tumor called glioblastoma or GBM\r\nKarnofsky performance status of ≥ 70 (able to take care of self)\r\nSubstantial recovery from surgery resection\r\nTumor test result shows MGMT methylated or indeterminate tumor subtype'}",{'Arm - Disease - Indication': 'Newly Diagnosed Adult MGMT-Methylated Glioblastoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02446704,"{'Official Title': 'Phase I/II Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy', 'Brief Summary': 'This research study is evaluating the combination of olaparib and temozolomide as a possible treatment for Small Cell Lung Cancer.', 'Condition': 'Small Cell Lung Cancer', 'Detailed Description': 'This research study is a Phase I/II clinical trial, which has two parts. The participant will be asked to participate in one part of the study. The first part tests the safety of the combination of drugs and tries to define the appropriate dose to use for future studies. The second part tests whether the combination of drugs is effective in treating small cell lung cancer. ""Investigational"" means that the combination of drugs is being studied. It also means that the U.S. Food and Drug Administration (FDA) has not approved the combination of drugs for Small Cell Lung Cancer.\r\n\r\nOlaparib (Lynparza) is FDA approved for the treatment of a type of ovarian cancer associated with a particular DNA change. Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and enable them to continue dividing. Olaparib has been used in research studies with other cancers. Information from those other research studies suggests that this drug may help to treat patients with small cell lung cancer. While it is not approved by the FDA for small cell lung cancer, it is considered part of standard treatment for other cancer.\r\n\r\nTemozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor, glioblastoma. It has been studied in small cell lung cancer in previous research studies. While it is not approved by the FDA for small cell lung cancer, it is considered part of standard treatment for relapsed disease.\r\n\r\nIn this research study, the investigators are looking for the maximum tolerated dose or MTD of the combination of olaparib and temozolomide that can be given safely. The investigators will also begin to collect information about the effects of the combination on small cell lung cancer', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients must meet the following criteria on screening examination to be eligible to participate in the study. The eligibility criteria apply to both the phase I and phase II portions of the study.\r\nParticipant must have histologically or cytologically confirmed small cell lung cancer and may not be a candidate for potentially curative therapy.\r\nPresence of measurable disease (RECIST 1.1): At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.\r\nThe small cell lung cancer must have progressed radiographically following a platinum-based (cisplatin and/or carboplatin) standard prior chemotherapy regimen. Any number of interval prior lines of therapy is allowed. Patients who have received prior platinum-based chemotherapy and radiation for limited stage SCLC and have subsequently developed relapsed disease are eligible, as long as the platinum-based therapy was given within 12 months prior to the time of relapse.\r\nParticipant (male/female) must be ≥18 years of age.\r\nParticipant must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:\r\n\r\nHemoglobin ≥ 10.0 g/dL\r\nAbsolute neutrophil count (ANC) ≥ 1.5 x 10^9/L\r\nPlatelet count ≥100 x 10^9/L\r\nTotal bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\r\nAST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (unless liver metastases are present in which case it must be ≤5 x ULN)\r\nSerum creatinine ≤1.5 x institutional upper limit of normal (ULN)\r\nECOG performance status 0-1\r\nParticipant must have a life expectancy ≥ 16 weeks.\r\nWomen of childbearing potential must have a negative urine or serum pregnancy test within 28 days of initial dose of olaparib and temozolomide AND must agree to the use of two highly effective forms of contraception (see Section 5.5) throughout their participation in the study and for at least 3 months after the last dose of olaparib and temozolomide, OR confirmed prior to treatment on day 1 to be postmenopausal or surgically sterile. Postmenopausal is defined as:\r\n\r\nAmenorrheic for 1 year or more following cessation of exogenous hormonal treatments,\r\nLH and FSH levels in the post menopausal range for women under 50,\r\nradiation-induced oophorectomy with last menses >1 year ago,\r\nchemotherapy-induced menopause with >1 year interval since last menses, or surgical sterilisation (bilateral oophorectomy or hysterectomy).\r\nParticipant is willing to comply with the protocol for the duration of the study, and undergo treatment and scheduled visits and examinations including follow up. Participant must obtain prior approval from insurance to reimburse for oral temozolomide for the duration of the study or agree to self-pay for oral temozolomide.'}",{'Arm - Disease - Indication': 'Recurrent Previously Treated Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05561036,"{'Official Title': 'A Randomized, Double-blind, Phase Ⅲ Study of Liposomal Doxorubicin in Desmoid Tumor', 'Brief Summary': 'The aim of this study was to evaluate the efficacy and safety of liposomal doxorubicin in the treatment of desmoid tumors. Unless the subject withdraws from the trial voluntarily, or the researcher considers that the subject is not suitable for further trial, each subject will be treated until the disease progresses or the toxic and side effects caused by the drug are intolerable, and then enter the survival follow-up period', 'Condition': 'Desmoid Tumor', 'Detailed Description': 'A randomized, double-blind, placebo-controlled study designed to compare (PFS) differences in progression-free survival in patients treated with liposome doxorubicin or placebo. PFS is defined as the time from randomization to the first occurrence of disease progression or death caused by any cause. If the disease is stable, PFS will be calculated at the time of the last follow-up in the study. Patients who have reached the maximum follow-up period and have no progress will be reviewed on the date of the last disease assessment. The crossover data of the patients were analyzed and summarized separately from the data of the main treatment process.In this study, 72 patients were expected to be enrolled in the group for 12 months and followed up for 24 months.Patients will be randomized to receive liposome adriamycin (50mg/m2) or intravenous placebo for a treatment cycle of once every 28 days.Duration of medication: a total of 6 cycles, or to the progression of the disease, tolerable toxicity, whichever occurs first.As the disease progresses, patients treated with placebo will be allowed to enter the unblinded liposome adriamycin group.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMust be confirmed as desmoid tumor by histopathology\r\nPatients should have measurable lesions defined by RECIST v1.1\r\nOne of the following conditions is satisfied\r\n\r\nThe disease should be defined as non resectable or tumor with disability after resection. The definition standard should meet one or more of the following characteristics\r\n\r\nMultiple lesions\r\n\r\nThe disease has involved or does not have enough blood vessel nerve bundle, bone, skin and fascia resection boundary\r\n\r\nLarge tumor or multiple chambers involved\r\nImaging showed progress (increased by 10% according to RECIST v1.1 standard size within 6 months before enrollment)\r\nThe BPI score of patients with symptomatic diseases was more than 3 points and met one of the following conditions:\r\n\r\nNSAIDs can not control pain, and consider increasing the control of narcotic drugs\r\n\r\nCurrent use of narcotic drugs increased by 30%\r\n\r\nNew opioid anesthetics needed\r\nPatients are allowed to receive chemotherapy, biological (antibody) therapy, immuno or experimental therapy, tyrosine kinase inhibitors, hormone therapy or NSAIDs treatment, provided that the treatment is completed at least 4 weeks before enrollment (6 weeks of mitomycin and nitrosourea treatment) and recovers from any treatment-related toxicity below CTCAE Level 2\r\nAge ≥ 1 year old, male or female\r\nECoG score ≤ 2\r\nResults of laboratory examination during screening: blood routine test: white blood cell count ≥ 3.0x 109 / L, absolute value of neutrophil ≥ 1.5 x 109 / L, platelet count ≥ 100 x 109 / L, hemoglobin ≥ 90 g / L; liver function: total bilirubin Results: serum creatinine ≤ 1.5 times of the upper limit of normal value; patients without liver metastasis had alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times of the upper limit of normal value; patients with liver metastasis had ALT and AST ≤ 5 times of the upper limit of normal value; renal function: serum creatinine ≤ 1.5 times of the upper normal value or creatinine clearance rate ≥ 50 ml / min, and urine protein < 2+\r\nFemale subjects of childbearing age, male subjects and partners of male subjects agreed to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, contraceptive injection or subcutaneous implantation) during the study and within 6 months after the infusion of study drug)\r\nUnderstand and accept the requirements of the study, provide written informed consent and authorization for the use and disclosure of protected information, and agree to comply with the research requirements and return to conduct the required visits'}",{'Arm - Disease - Indication': 'Desmoid Tumor'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05561036,"{'Official Title': 'A Randomized, Double-blind, Phase Ⅲ Study of Liposomal Doxorubicin in Desmoid Tumor', 'Brief Summary': 'The aim of this study was to evaluate the efficacy and safety of liposomal doxorubicin in the treatment of desmoid tumors. Unless the subject withdraws from the trial voluntarily, or the researcher considers that the subject is not suitable for further trial, each subject will be treated until the disease progresses or the toxic and side effects caused by the drug are intolerable, and then enter the survival follow-up period', 'Condition': 'Desmoid Tumor', 'Detailed Description': 'A randomized, double-blind, placebo-controlled study designed to compare (PFS) differences in progression-free survival in patients treated with liposome doxorubicin or placebo. PFS is defined as the time from randomization to the first occurrence of disease progression or death caused by any cause. If the disease is stable, PFS will be calculated at the time of the last follow-up in the study. Patients who have reached the maximum follow-up period and have no progress will be reviewed on the date of the last disease assessment. The crossover data of the patients were analyzed and summarized separately from the data of the main treatment process.In this study, 72 patients were expected to be enrolled in the group for 12 months and followed up for 24 months.Patients will be randomized to receive liposome adriamycin (50mg/m2) or intravenous placebo for a treatment cycle of once every 28 days.Duration of medication: a total of 6 cycles, or to the progression of the disease, tolerable toxicity, whichever occurs first.As the disease progresses, patients treated with placebo will be allowed to enter the unblinded liposome adriamycin group.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMust be confirmed as desmoid tumor by histopathology\r\nPatients should have measurable lesions defined by RECIST v1.1\r\nOne of the following conditions is satisfied\r\n\r\nThe disease should be defined as non resectable or tumor with disability after resection. The definition standard should meet one or more of the following characteristics\r\n\r\nMultiple lesions\r\n\r\nThe disease has involved or does not have enough blood vessel nerve bundle, bone, skin and fascia resection boundary\r\n\r\nLarge tumor or multiple chambers involved\r\nImaging showed progress (increased by 10% according to RECIST v1.1 standard size within 6 months before enrollment)\r\nThe BPI score of patients with symptomatic diseases was more than 3 points and met one of the following conditions:\r\n\r\nNSAIDs can not control pain, and consider increasing the control of narcotic drugs\r\n\r\nCurrent use of narcotic drugs increased by 30%\r\n\r\nNew opioid anesthetics needed\r\nPatients are allowed to receive chemotherapy, biological (antibody) therapy, immuno or experimental therapy, tyrosine kinase inhibitors, hormone therapy or NSAIDs treatment, provided that the treatment is completed at least 4 weeks before enrollment (6 weeks of mitomycin and nitrosourea treatment) and recovers from any treatment-related toxicity below CTCAE Level 2\r\nAge ≥ 1 year old, male or female\r\nECoG score ≤ 2\r\nResults of laboratory examination during screening: blood routine test: white blood cell count ≥ 3.0x 109 / L, absolute value of neutrophil ≥ 1.5 x 109 / L, platelet count ≥ 100 x 109 / L, hemoglobin ≥ 90 g / L; liver function: total bilirubin Results: serum creatinine ≤ 1.5 times of the upper limit of normal value; patients without liver metastasis had alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times of the upper limit of normal value; patients with liver metastasis had ALT and AST ≤ 5 times of the upper limit of normal value; renal function: serum creatinine ≤ 1.5 times of the upper normal value or creatinine clearance rate ≥ 50 ml / min, and urine protein < 2+\r\nFemale subjects of childbearing age, male subjects and partners of male subjects agreed to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, contraceptive injection or subcutaneous implantation) during the study and within 6 months after the infusion of study drug)\r\nUnderstand and accept the requirements of the study, provide written informed consent and authorization for the use and disclosure of protected information, and agree to comply with the research requirements and return to conduct the required visits'}",{'Arm - Disease - Indication': 'Desmoid Tumor'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04982237,"{'Official Title': 'A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nsigns the written informed consent form.\r\nWomen aged ≥ 18 and ≤ 75 years.\r\nECOG of 0 or 1.\r\nLife expectancy ≥ 3 months.\r\nHistologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy.\r\n\r\nThe histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma;\r\nNo prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease.\r\nAt least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.\r\nAll subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy.\r\nSubjects must have adequate organ function as assessed in the laboratory tests.\r\nFemale subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug.'}",{'Arm - Disease - Indication': 'First-Line Persistent Recurrent or Metastatic Cervical Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04982237,"{'Official Title': 'A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nsigns the written informed consent form.\r\nWomen aged ≥ 18 and ≤ 75 years.\r\nECOG of 0 or 1.\r\nLife expectancy ≥ 3 months.\r\nHistologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy.\r\n\r\nThe histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma;\r\nNo prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease.\r\nAt least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.\r\nAll subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy.\r\nSubjects must have adequate organ function as assessed in the laboratory tests.\r\nFemale subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug.'}",{'Arm - Disease - Indication': 'First-Line Persistent Recurrent or Metastatic Cervical Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03631199,"{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)', 'Brief Summary': 'This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.\r\n\r\nThe study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.', 'Condition': 'Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting\r\nKnown PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.\r\nEastern Cooperative oncology group (ECOG) performance status of 0 or 1.\r\nAt least 1 measurable lesion by RECIST 1.1'}",{'Arm - Disease - Indication': 'Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03631199,"{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)', 'Brief Summary': 'This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.\r\n\r\nThe study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.', 'Condition': 'Non-small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion criteria:\n\nHistologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting\nKnown PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.\nEastern Cooperative oncology group (ECOG) performance status of 0 or 1.\nAt least 1 measurable lesion by RECIST 1.1'}",{'Arm - Disease - Indication': 'Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05052801,"{'Official Title': 'A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression', 'Brief Summary': 'The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)', 'Condition': 'Gastric Cancer\nGastroesophageal Junction Adenocarcinoma', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nAdults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy\nFibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy\nEastern Cooperative Oncology Group (ECOG) less than or equal to 1\nMeasurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1\nParticipant has no contraindications to mFOLFOX6 chemotherapy\nAdequate organ and bone marrow function:\n\nabsolute neutrophil count greater than or equal to 1.5 times 10^9/L\nplatelet count greater than or equal to 100 times 10^9/L\nhemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment\naspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)\ncalculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)\ninternational normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment""}",{'Arm - Disease - Indication': 'Previously Untreated FGFR2b Overexpressed Adult Unresectable Advanced Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05052801,"{'Official Title': 'A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression', 'Brief Summary': 'The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)', 'Condition': 'Gastric Cancer\nGastroesophageal Junction Adenocarcinoma', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nAdults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy\nFibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy\nEastern Cooperative Oncology Group (ECOG) less than or equal to 1\nMeasurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1\nParticipant has no contraindications to mFOLFOX6 chemotherapy\nAdequate organ and bone marrow function:\n\nabsolute neutrophil count greater than or equal to 1.5 times 10^9/L\nplatelet count greater than or equal to 100 times 10^9/L\nhemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment\naspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)\ncalculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)\ninternational normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment""}",{'Arm - Disease - Indication': 'Previously Untreated FGFR2b Overexpressed Adult Unresectable Advanced Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02891824,"{'Official Title': 'A Randomized, Double-blinded, Phase III Study of Atezolizumab Versus Placebo in Patients With Late Relapse of Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated by Platinum-based Chemotherapy and Bevacizumab', 'Brief Summary': 'This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months).', 'Condition': 'Ovarian Cancer', 'Detailed Description': 'Approximately 600 patients will be randomized using an Interactive Voice Response System /Interactive web system (IVR/IWR system) in a 1:2 ratio to the treatments as specified below:\r\n\r\nA. Arm A: Placebo + bevacizumab & platinum-based chemotherapy.\r\n\r\nThe placebo arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)\r\n\r\nCarboplatin (day1)combined with gemcitabine (day1 & day8) and bevacizumab (day1) + placebo ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab ( day1) + placebo (day1) q3weeks until disease progression or\r\nCarboplatin (d1) combined with paclitaxel (day1) and bevacizumab (day1) + placebo (d1) x 6 cycles every 3weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression or\r\nCarboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 & 15) + placebo ( day1& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression.\r\nB. Arm B: Atezolizumab + bevacizumab & platinum-based chemotherapy\r\n\r\nThe atezolizumab arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)\r\n\r\nCarboplatin (day1) combined with gemcitabine (day1 & d8) and bevacizumab (day1) + atezolizumab ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab (day1) + atezolizumab (day1) q3w until disease progression or\r\nCarboplatin (day1) combined with paclitaxel (day1) and bevacizumab ( day1) + atezolizumab (1200mg, d1) x 6 cycles every 3wk (day1) q3weeks until disease progression or\r\nCarboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 & 15) + atezolizumab (day1& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + atezolizumab ( day1) q3weeks until disease progression.\r\nBefore randomization to the study:\r\n\r\nA tumor biopsy should have been obtained and sent to the central laboratory\r\nPD-L1 status should be determined', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nFemale Patients must be ≥18 years of age.\r\nSigned informed consent and ability to comply with treatment and follow-up.\r\nPatients with histologically confirmed progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma\r\nPatients with PD-L1 status determined for stratification on mandatory de novo biopsy sent to central laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample.\r\n\r\nCell pellet from pleural effusion, or ascites or lavage are not acceptable.\r\nFor core needle biopsy specimens, at least three cores should be obtained. Biopsies must be obtained in a manner that minimizes risks. If the location of the tumor renders tumor biopsy medically unsafe or not feasible, patient eligibility should be discussed with the sponsor.\r\nPatients whose disease has relapsed more than 6 months from the last dose of platinum before randomization:\r\n\r\ncriterion for relapse can be according to RECIST v1.1, CA-125 (GCIG) or clinical symptoms\r\nthe interval between last dose of platinum and entry in the study should be free of new anti-cancer treatment, with the exception of a maintenance therapy which is allowed up to 21 days before study entry.\r\nPatients with one or 2 prior lines of chemotherapy. The last line of chemotherapy should have included platinum.\r\nAvailability at the study site of representative FFPE tumor sample from surgery during front line therapy, at best before chemotherapy\r\nPatients must have normal organ and bone marrow function :\r\n\r\nHaemoglobin ≥ 10.0 g/dL.\r\nAbsolute neutrophil count (ANC) ≥ 1.5 x 109/L.\r\nPlatelet count ≥ 100 x 109/L.\r\nTotal bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).\r\nAspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.\r\nSerum creatinine ≤ 1.5 x institutional ULN,\r\nPatients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at the time of randomization.\r\nUrine dipstick for proteinuria < 2+. If urine dipstick is ≥2+, 24-hours urine must demonstrate ≤1 g of protein in 24 hours.\r\nNormal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).\r\nEastern Cooperative Oncology Group (ECOG) performance status 0-1\r\nFor France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category'}",{'Arm - Disease - Indication': 'Platinum Sensitive Late Relapsed Non Mucinous Epithelial Ovarian or Primary Peritoneal/Fallopian Tube Adenocarcinoma Treated With Chemotherapy Plus Bevacizumab'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02891824,"{'Official Title': 'A Randomized, Double-blinded, Phase III Study of Atezolizumab Versus Placebo in Patients With Late Relapse of Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated by Platinum-based Chemotherapy and Bevacizumab', 'Brief Summary': 'This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months).', 'Condition': 'Ovarian Cancer', 'Detailed Description': 'Approximately 600 patients will be randomized using an Interactive Voice Response System /Interactive web system (IVR/IWR system) in a 1:2 ratio to the treatments as specified below:\r\n\r\nA. Arm A: Placebo + bevacizumab & platinum-based chemotherapy.\r\n\r\nThe placebo arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)\r\n\r\nCarboplatin (day1)combined with gemcitabine (day1 & day8) and bevacizumab (day1) + placebo ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab ( day1) + placebo (day1) q3weeks until disease progression or\r\nCarboplatin (d1) combined with paclitaxel (day1) and bevacizumab (day1) + placebo (d1) x 6 cycles every 3weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression or\r\nCarboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 & 15) + placebo ( day1& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression.\r\nB. Arm B: Atezolizumab + bevacizumab & platinum-based chemotherapy\r\n\r\nThe atezolizumab arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)\r\n\r\nCarboplatin (day1) combined with gemcitabine (day1 & d8) and bevacizumab (day1) + atezolizumab ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab (day1) + atezolizumab (day1) q3w until disease progression or\r\nCarboplatin (day1) combined with paclitaxel (day1) and bevacizumab ( day1) + atezolizumab (1200mg, d1) x 6 cycles every 3wk (day1) q3weeks until disease progression or\r\nCarboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 & 15) + atezolizumab (day1& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + atezolizumab ( day1) q3weeks until disease progression.\r\nBefore randomization to the study:\r\n\r\nA tumor biopsy should have been obtained and sent to the central laboratory\r\nPD-L1 status should be determined', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nFemale Patients must be ≥18 years of age.\r\nSigned informed consent and ability to comply with treatment and follow-up.\r\nPatients with histologically confirmed progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma\r\nPatients with PD-L1 status determined for stratification on mandatory de novo biopsy sent to central laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample.\r\n\r\nCell pellet from pleural effusion, or ascites or lavage are not acceptable.\r\nFor core needle biopsy specimens, at least three cores should be obtained. Biopsies must be obtained in a manner that minimizes risks. If the location of the tumor renders tumor biopsy medically unsafe or not feasible, patient eligibility should be discussed with the sponsor.\r\nPatients whose disease has relapsed more than 6 months from the last dose of platinum before randomization:\r\n\r\ncriterion for relapse can be according to RECIST v1.1, CA-125 (GCIG) or clinical symptoms\r\nthe interval between last dose of platinum and entry in the study should be free of new anti-cancer treatment, with the exception of a maintenance therapy which is allowed up to 21 days before study entry.\r\nPatients with one or 2 prior lines of chemotherapy. The last line of chemotherapy should have included platinum.\r\nAvailability at the study site of representative FFPE tumor sample from surgery during front line therapy, at best before chemotherapy\r\nPatients must have normal organ and bone marrow function :\r\n\r\nHaemoglobin ≥ 10.0 g/dL.\r\nAbsolute neutrophil count (ANC) ≥ 1.5 x 109/L.\r\nPlatelet count ≥ 100 x 109/L.\r\nTotal bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).\r\nAspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.\r\nSerum creatinine ≤ 1.5 x institutional ULN,\r\nPatients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at the time of randomization.\r\nUrine dipstick for proteinuria < 2+. If urine dipstick is ≥2+, 24-hours urine must demonstrate ≤1 g of protein in 24 hours.\r\nNormal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).\r\nEastern Cooperative Oncology Group (ECOG) performance status 0-1\r\nFor France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category'}",{'Arm - Disease - Indication': 'Platinum Sensitive Late Relapsed Non Mucinous Epithelial Ovarian or Primary Peritoneal/Fallopian Tube Adenocarcinoma Treated With Chemotherapy Plus Bevacizumab'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05029102,"{'Official Title': 'TAS-102 Combined With Anlotinib in Patients With Metastatic Gastric Cancer Refractory to Standard Treatments (THALIA): a Prospective Single-arm Phase II Study', 'Brief Summary': 'To determine the efficacy and safety of TAS-102 and Anlotinib in patients with metastatic gastric cancer who had been treated with ≥ 2 lines of prior standard chemotherapy', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAge ≥ 18 years, ≤75 years\r\nHistologically confirmed gastric cancer with distant metastasis\r\nECOG 0-1\r\nProgression on ≥ 2 lines of prior standard chemotherapy\r\nPatients can swallow pills normally\r\nExpected overall survival ≥6 months\r\nBlood routine: no blood transfusion or blood products usage within 14 days, G-CSF or other hematopoietic stimulator was not used. WBC counts > 3000/µl，Absolute neutrophil count (ANC) ≥ 1500 cells/µl，Platelet count ≥ 100,000/µl，Hemoglobin ≥ 9.0 g/dL.\r\nAST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine= 18 years\nEastern Cooperative Oncology Group (ECOG) =< 1\nLife expectancy >= 3 months\nAble to swallow and absorb oral tablets\nHistological or cytological confirmed advanced, metastatic, or progressive proficient mismatch repair (pMMR)/MSS adenocarcinoma of colon or rectum\n\nMicrosatellite status should be performed per local standard of practice (e.g., immunohistochemistry [IHC] and/or polymerase chain reaction [PCR], or next-generation sequencing). Only participants with pMMR/MSS mCRC are eligible\nPatients should have measurable metastatic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines\nKnown extended RAS and BRAF status as per local standard of practice. TMB and PD-L1 status will be collected when available but not mandated for enrollment\nPatients must have progressed following exposure to all of the following agents:\n\nFluoropyrimidines (capecitabine or 5-FU)\nIrinotecan\nOxaliplatin\nAnti-EGFR therapy if RAS and BRAF wild type with left colon primary\nPatients must have evidence of progression on or after the last treatment received and within 6 months prior to study enrollment\n\nPatients who were intolerant to prior systemic chemotherapy regimens are eligible if there is documented evidence of clinically significant intolerance despite adequate supportive measures\nAdjuvant/neoadjuvant chemotherapy can be considered as one line of chemotherapy for advanced/metastatic disease if the participant had disease recurrence within 6 months of completion\nFor patients with liver metastatic disease, patients must have no more than 5 hepatic metastases at the time of enrollment\nPatients without liver metastatic disease should be either with no history of liver metastatic disease or with history of resected or ablated liver metastases without evidence of disease recurrence in the liver for at least 6 months before enrollment\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAspartate aminotransferase (AST) =< 2.5 x ULN, unless presence of liver metastases for which =< 5 x ULN is allowed (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAlanine aminotransferase (ALT) =< 2.5 x ULN, unless presence of liver metastases for which =< 5 x ULN is allowed (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nSerum creatinine =< 1.5 x ULN or creatinine clearance >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nWhite blood cell (WBC) >= 2000/ul (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nHemoglobin >= 9 g/dl (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAbsolute neutrophil count (ANC) >= 1500/ul (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nPlatelets >= 75,000/mm^3 (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAlbumin >= 3.0 g/dl (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nWomen of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAgreement by females and males of childbearing potential to use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of protocol therapy\n\nFemales of non-childbearing potential defined as:\n\n>= 50 years of age and has not had menses for greater than 1 year\nAmenorrheic for >= 2 years without a hysterectomy and bilateral oophorectomy and a follicle stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation\nStatus is post-hysterectomy, bilateral oophorectomy, or tubal ligation'}",{'Arm - Disease - Indication': 'Advanced Metastatic Progressive Microsatellite Stable Colorectal Adenocarcinoma '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02257736,"{'Official Title': 'A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)', 'Brief Summary': 'The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': ""This is a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know the treatment) placebo-controlled and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to determine if participants with chemotherapy-naive mCRPC will benefit from the addition of apalutamide to AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment phase, and Follow-up phase. At the final analysis, the study will be unblinded. After the Independent Data Monitoring Committee (IDMC) review and the sponsor's subsequent decision participants will be offered to receive treatment either in the Open-Label Extension Phase or the Long-Term Extension Phase of study. Participants' safety will be monitored throughout the study."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nAdenocarcinoma of the prostate\nMetastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter\nCastration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)\nParticipants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period\nProstate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2\nParticipants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.'}",{'Arm - Disease - Indication': 'Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02257736,"{'Official Title': 'A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)', 'Brief Summary': 'The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': ""This is a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know the treatment) placebo-controlled and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to determine if participants with chemotherapy-naive mCRPC will benefit from the addition of apalutamide to AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment phase, and Follow-up phase. At the final analysis, the study will be unblinded. After the Independent Data Monitoring Committee (IDMC) review and the sponsor's subsequent decision participants will be offered to receive treatment either in the Open-Label Extension Phase or the Long-Term Extension Phase of study. Participants' safety will be monitored throughout the study."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nAdenocarcinoma of the prostate\nMetastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter\nCastration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)\nParticipants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period\nProstate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2\nParticipants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.'}",{'Arm - Disease - Indication': 'Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05353257,"{'Official Title': 'A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer', 'Brief Summary': 'This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.', 'Condition': 'Limited-Stage Small Cell Lung Cancer', 'Detailed Description': 'Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.\r\n\r\nArm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale or female, aged ≥18 years when signing the ICF.\r\nHistologically diagnosed with SCLC.\r\nDiagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.\r\nMajor organs are functioning well.'}",{'Arm - Disease - Indication': 'Limited Stage Stage I to Stage III Small-Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05353257,"{'Official Title': 'A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer', 'Brief Summary': 'This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.', 'Condition': 'Limited-Stage Small Cell Lung Cancer', 'Detailed Description': 'Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.\r\n\r\nArm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale or female, aged ≥18 years when signing the ICF.\r\nHistologically diagnosed with SCLC.\r\nDiagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.\r\nMajor organs are functioning well.'}",{'Arm - Disease - Indication': 'Limited Stage Stage I to Stage III Small-Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05328908,"{'Official Title': 'A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer', 'Brief Summary': 'The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.', 'Condition': 'Colorectal Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry\r\nParticipants must have:\r\n\r\nprogressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;\r\nbeen intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures\r\nMust have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements\r\nMust have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately'}",{'Arm - Disease - Indication': 'Non Microsatellite Instability High / Deficient Mismatch Repair Previously Treated Metastatic Colorectal Cancer Progressive During At Least 1 But Not More Than 4 Prior Lines of Therapies'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05328908,"{'Official Title': 'A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer', 'Brief Summary': 'The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.', 'Condition': 'Colorectal Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry\r\nParticipants must have:\r\n\r\nprogressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;\r\nbeen intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures\r\nMust have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements\r\nMust have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately'}",{'Arm - Disease - Indication': 'Non Microsatellite Instability High / Deficient Mismatch Repair Previously Treated Metastatic Colorectal Cancer Progressive During At Least 1 But Not More Than 4 Prior Lines of Therapies'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03959293,"{'Official Title': 'A Randomized Phase II Study Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma', 'Brief Summary': 'Gastric adenocarcinoma is the 4th most frequent cancer and the 2nd leading cause of cancer mortality. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone).\n\nSecond-line chemotherapy-based treatment improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012).\n\nBased on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. The present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Condition': 'Gastric Adenocarcinoma\nGastric Cancer', 'Detailed Description': 'Gastric adenocarcinoma is the fourth most frequent cancer and the second leading cause of cancer mortality. Advanced gastric adenocarcinoma has a poor prognosis with short overall survival (ranging from 10% to 15% at 5-years) even after surgical complete resection and despite the progress in therapeutic approaches. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone). First-line chemotherapy depends on HER2 status, which also influenced overall survival (14 months for HER2 positive versus 10 months for HER2 negative tumors). In HER2 negative tumors standard first-line regimen is a doublet of fluoropyrimidine (5-fluorouracil or capecitabine) plus a platinum salt (cisplatin or oxaliplatin). 5-fluorouracil (5-FU) and capecitabine as also cisplatin and oxaliplatin have similar efficacy but different toxicities.\n\nIn patients whose tumor overexpresses the HER2 receptor adding trastuzumab to fluoropyrimidine/cisplatin regimen increased overall survival compared to chemotherapy alone. In HER2 negative tumors the addition of docetaxel to cisplatin/fluoropyrimidine regimen increased overall survival but its use remains limited in clinical practice because of its high toxicity. Preliminary results demonstrated a high efficacy with less toxicities of docetaxel-oxaliplatin-fluoropyrimidine combination, also called TFOX/FLOT regimen. Indeed, in France a large phase III trial comparing TFOX versus FOLFOX in first-line treatment of patients with advanced gastric or gastro-oesophageal junction adenocarcinoma is ongoing (GASTFOX, trial NCT03006432). Primary endpoint is progression-free survival (PFS) and 506 patients are planned between 2017 and 2020 (actually at the date of January 30, 2018, 65 patients are included).\n\nSecond-line chemotherapy improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Weekly paclitaxel monotherapy is also used because of its good efficacy-toxicity ratio. Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012). Recently ramucirumab monotherapy demonstrated its efficacy on overall survival in a randomized, placebo-controlled second-line metastatic study. In a randomized phase 3 trial ramucirumab also showed its efficacy in combination with paclitaxel versus paclitaxel monotherapy with a median overall survival of 9.6 versus 7.4 months, respectively (p=0.017; HR=0.81). However, the ""amelioration du service medical rendu"" (ASMR) assessed by the French ""Haute Autorité de Santé"" (HAS) consider an insufficient benefit to a reimbursement of ramucirumab in France. The HAS gave a moderate ASMR opinion (ASMR IV).\n\nDocetaxel is more and more frequently used in first-line chemotherapy then in this setting taxane (alone or combined with others drugs) cannot be used as second-line regimen. Indeed, based on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nHuman tumors tend to activate the immune system regulatory checkpoints as a means of escaping immunosurveillance. For instance, interaction between PD1 (Program Death 1) and PD-L1 (Program Death 1 ligand) will lead the activated T cell to a state of anergy. PD-L1 is up regulated on a wide range of cancers. Anti-PD1 and anti-PD-L1 monoclonal antibodies (mAbs), called immune checkpoint inhibitors (ICIs), have consequently been designed to restore T cell activity. Others ICIs are investigated, notably cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors. CTLA-4 transmits an inhibitory signal to T cells to prevent early excessive T cell activation. CTLA4 blockade may stimulate a more robust antitumor response by sustaining activation and proliferation of T lymphocytes and may overcome immune suppression mediated by regulatory T cells. ICIs have been recently tested in many cancers with promising results, especially in tumors with microsatellite instability (MSI) and/or PD-L1 overexpression.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. Finally, immunogenic cell death induced by chemotherapy may enhance efficacy of ICIs. Durvalumab (MEDI4736) is a human monoclonal antibody directed against PD-L1 in development for the treatment of many cancers. A phase I study included 16 patients with advanced gastric cancer and the objective response rate was 25%. Tremelimumab is a fully human monoclonal antibody against CTLA-4. Durvalumab plus tremelimumab combination showed a manageable tolerability profile, with antitumour activity irrespective of PD-L1 status in non-small cell lung cancer (NSCLC). Durvalumab alone or combined with tremelimumab is evaluated in phase III studies in NSCLC (e.g NEPTUNE and MYSTIC), small cell lung cancer (CASPIAN), hepatocellular carcinoma (HIMALAYA), bladder cancer (DANUBE) and head and neck cancer (EAGLE and KESTREL).\n\nConcerning safety of anti-PD1 plus anti-CTLA4 combination, in the randomized phase I/II CheckMate-032 study, that included 160 patients, there was no unexpected toxicity signal. Grade 3 and 4 treatment-related adverse events were 17%, 47%, and 27%, respectively. These rates of grade 3 and 4 treatment-related adverse events are those usually found with the anti-PD1 plus anti-CTLA4 combination in other tumors, observed approximately in 40% of patients. Up until now, there is no published data concerning combination of ICIs plus irinotecan. Nevertheless, in all trial combining chemotherapy plus anti-PD1 and/or anti-CTLA4 chemotherapy drugs were used at full-dose (5FU, oxaliplatin, cisplatin…). An Italian trial just started and combined full-dose FOLFOXIRI (5-FU 3200 mg/m2 plus irinotecan 165 mg/m2 and oxaliplatin 85 mg/m2) with bevacizumab (5 mg/kg) and atezolizumab (anti-PD-L1, 840 mg) in metastatic colorectal cancers as first-line treatment. FOLFOXIRI is a triplet chemotherapy more ""toxic"" than FOLFIRI doublet chemotherapy and this trial is a randomized phase II (FOLFOXIRI plus bevacizumab and atezolizumab versus FOLFOXIRI plus bevacizumab). There is, however, a preliminary safety phase in 6 patients, once they have all received at least 2 cycles of treatment, the latter being administered at full dose (AtezoTRIBE trial, NCT03721653).\n\nThe present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥ 18 years.\nBody weight > 30kg.\nHistologically proven advanced-stage unresectable adenocarcinoma of the stomach or the GEJ (Siewert II or III).\nKnown MSS/MSI status or tumor tissue available (frozen or paraffin-embedded, primary tumors or metastases) in order to allow determination of MSS/MSI status. The investigator needs to ensure that tumor tissues will be sent after patient randomization.\nFailure to platinium-based 1st line therapy with or without trastuzumab, or early recurrent disease after surgery with neo-adjuvant and/or adjuvant platinium-based chemotherapy (within 6 months of the end of chemotherapy) or progression during neo-adjuvant and/or adjuvant platinium-based chemotherapy.\nEligible for a second-line treatment with irinotecan and 5-FU.\nMeasurable or non-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\nEastern Cooperative Oncology Group (ECOG) performance status 0-1.\nAdequate organ function: ANC ≥ 1.5 x 109/L, haemoglobin ≥ 9 g/dL, platelets ≥ 100 x 109/L, AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), GGT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), bilirubin ≤ 1.5 x ULN, creatinin clearance > 40 mL/min (MDRD).\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.\nMan and woman who childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.\nPatient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.'}",{'Arm - Disease - Indication': 'Advanced Unresectable Gastric or Gastro-oesophageal Junction Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03959293,"{'Official Title': 'A Randomized Phase II Study Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma\n', 'Brief Summary': 'Gastric adenocarcinoma is the 4th most frequent cancer and the 2nd leading cause of cancer mortality. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone).\n\nSecond-line chemotherapy-based treatment improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012).\n\nBased on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. The present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Condition': 'Gastric Adenocarcinoma\nGastric Cancer', 'Detailed Description': 'Gastric adenocarcinoma is the fourth most frequent cancer and the second leading cause of cancer mortality. Advanced gastric adenocarcinoma has a poor prognosis with short overall survival (ranging from 10% to 15% at 5-years) even after surgical complete resection and despite the progress in therapeutic approaches. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone). First-line chemotherapy depends on HER2 status, which also influenced overall survival (14 months for HER2 positive versus 10 months for HER2 negative tumors). In HER2 negative tumors standard first-line regimen is a doublet of fluoropyrimidine (5-fluorouracil or capecitabine) plus a platinum salt (cisplatin or oxaliplatin). 5-fluorouracil (5-FU) and capecitabine as also cisplatin and oxaliplatin have similar efficacy but different toxicities.\n\nIn patients whose tumor overexpresses the HER2 receptor adding trastuzumab to fluoropyrimidine/cisplatin regimen increased overall survival compared to chemotherapy alone. In HER2 negative tumors the addition of docetaxel to cisplatin/fluoropyrimidine regimen increased overall survival but its use remains limited in clinical practice because of its high toxicity. Preliminary results demonstrated a high efficacy with less toxicities of docetaxel-oxaliplatin-fluoropyrimidine combination, also called TFOX/FLOT regimen. Indeed, in France a large phase III trial comparing TFOX versus FOLFOX in first-line treatment of patients with advanced gastric or gastro-oesophageal junction adenocarcinoma is ongoing (GASTFOX, trial NCT03006432). Primary endpoint is progression-free survival (PFS) and 506 patients are planned between 2017 and 2020 (actually at the date of January 30, 2018, 65 patients are included).\n\nSecond-line chemotherapy improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Weekly paclitaxel monotherapy is also used because of its good efficacy-toxicity ratio. Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012). Recently ramucirumab monotherapy demonstrated its efficacy on overall survival in a randomized, placebo-controlled second-line metastatic study. In a randomized phase 3 trial ramucirumab also showed its efficacy in combination with paclitaxel versus paclitaxel monotherapy with a median overall survival of 9.6 versus 7.4 months, respectively (p=0.017; HR=0.81). However, the ""amelioration du service medical rendu"" (ASMR) assessed by the French ""Haute Autorité de Santé"" (HAS) consider an insufficient benefit to a reimbursement of ramucirumab in France. The HAS gave a moderate ASMR opinion (ASMR IV).\n\nDocetaxel is more and more frequently used in first-line chemotherapy then in this setting taxane (alone or combined with others drugs) cannot be used as second-line regimen. Indeed, based on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nHuman tumors tend to activate the immune system regulatory checkpoints as a means of escaping immunosurveillance. For instance, interaction between PD1 (Program Death 1) and PD-L1 (Program Death 1 ligand) will lead the activated T cell to a state of anergy. PD-L1 is up regulated on a wide range of cancers. Anti-PD1 and anti-PD-L1 monoclonal antibodies (mAbs), called immune checkpoint inhibitors (ICIs), have consequently been designed to restore T cell activity. Others ICIs are investigated, notably cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors. CTLA-4 transmits an inhibitory signal to T cells to prevent early excessive T cell activation. CTLA4 blockade may stimulate a more robust antitumor response by sustaining activation and proliferation of T lymphocytes and may overcome immune suppression mediated by regulatory T cells. ICIs have been recently tested in many cancers with promising results, especially in tumors with microsatellite instability (MSI) and/or PD-L1 overexpression.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. Finally, immunogenic cell death induced by chemotherapy may enhance efficacy of ICIs. Durvalumab (MEDI4736) is a human monoclonal antibody directed against PD-L1 in development for the treatment of many cancers. A phase I study included 16 patients with advanced gastric cancer and the objective response rate was 25%. Tremelimumab is a fully human monoclonal antibody against CTLA-4. Durvalumab plus tremelimumab combination showed a manageable tolerability profile, with antitumour activity irrespective of PD-L1 status in non-small cell lung cancer (NSCLC). Durvalumab alone or combined with tremelimumab is evaluated in phase III studies in NSCLC (e.g NEPTUNE and MYSTIC), small cell lung cancer (CASPIAN), hepatocellular carcinoma (HIMALAYA), bladder cancer (DANUBE) and head and neck cancer (EAGLE and KESTREL).\n\nConcerning safety of anti-PD1 plus anti-CTLA4 combination, in the randomized phase I/II CheckMate-032 study, that included 160 patients, there was no unexpected toxicity signal. Grade 3 and 4 treatment-related adverse events were 17%, 47%, and 27%, respectively. These rates of grade 3 and 4 treatment-related adverse events are those usually found with the anti-PD1 plus anti-CTLA4 combination in other tumors, observed approximately in 40% of patients. Up until now, there is no published data concerning combination of ICIs plus irinotecan. Nevertheless, in all trial combining chemotherapy plus anti-PD1 and/or anti-CTLA4 chemotherapy drugs were used at full-dose (5FU, oxaliplatin, cisplatin…). An Italian trial just started and combined full-dose FOLFOXIRI (5-FU 3200 mg/m2 plus irinotecan 165 mg/m2 and oxaliplatin 85 mg/m2) with bevacizumab (5 mg/kg) and atezolizumab (anti-PD-L1, 840 mg) in metastatic colorectal cancers as first-line treatment. FOLFOXIRI is a triplet chemotherapy more ""toxic"" than FOLFIRI doublet chemotherapy and this trial is a randomized phase II (FOLFOXIRI plus bevacizumab and atezolizumab versus FOLFOXIRI plus bevacizumab). There is, however, a preliminary safety phase in 6 patients, once they have all received at least 2 cycles of treatment, the latter being administered at full dose (AtezoTRIBE trial, NCT03721653).\n\nThe present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥ 18 years.\nBody weight > 30kg.\nHistologically proven advanced-stage unresectable adenocarcinoma of the stomach or the GEJ (Siewert II or III).\nKnown MSS/MSI status or tumor tissue available (frozen or paraffin-embedded, primary tumors or metastases) in order to allow determination of MSS/MSI status. The investigator needs to ensure that tumor tissues will be sent after patient randomization.\nFailure to platinium-based 1st line therapy with or without trastuzumab, or early recurrent disease after surgery with neo-adjuvant and/or adjuvant platinium-based chemotherapy (within 6 months of the end of chemotherapy) or progression during neo-adjuvant and/or adjuvant platinium-based chemotherapy.\nEligible for a second-line treatment with irinotecan and 5-FU.\nMeasurable or non-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\nEastern Cooperative Oncology Group (ECOG) performance status 0-1.\nAdequate organ function: ANC ≥ 1.5 x 109/L, haemoglobin ≥ 9 g/dL, platelets ≥ 100 x 109/L, AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), GGT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), bilirubin ≤ 1.5 x ULN, creatinin clearance > 40 mL/min (MDRD).\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.\nMan and woman who childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.\nPatient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.'}",{'Arm - Disease - Indication': 'Advanced Unresectable Gastric or Gastro-oesophageal Junction Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03863483,"{'Official Title': 'A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy', 'Brief Summary': 'This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.', 'Condition': 'Nonsquamous Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVolunteer to participate in clinical research; fully understand and know the research and sign informed consent;\r\nAge ≥ 18 years old and ≤ 75 years old, either sex;\r\nEastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;\r\nHas a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;\r\nHave at least one measurable lesion as defined by RECIST 1.1;\r\nHas progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;\r\nPatients without activating EGFR mutation;\r\nNormal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present;\r\nNormal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );\r\nNormal hematological function: absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];\r\nHas a life expectancy of at ≥3 months.'}",{'Arm - Disease - Indication': 'Second-Line Wild-Type EGFR Stage IV Nonsquamous Non-small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03863483,"{'Official Title': 'A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy', 'Brief Summary': 'This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.', 'Condition': 'Nonsquamous Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVolunteer to participate in clinical research; fully understand and know the research and sign informed consent;\r\nAge ≥ 18 years old and ≤ 75 years old, either sex;\r\nEastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;\r\nHas a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;\r\nHave at least one measurable lesion as defined by RECIST 1.1;\r\nHas progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;\r\nPatients without activating EGFR mutation;\r\nNormal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present;\r\nNormal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );\r\nNormal hematological function: absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];\r\nHas a life expectancy of at ≥3 months.'}",{'Arm - Disease - Indication': 'Second-Line Wild-Type EGFR Stage IV Nonsquamous Non-small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05179239,"{'Official Title': 'A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ≥ 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}","{'Arm - Disease - Indication': 'First-Line Persistent, Recurrent, or Metastatic Cervical Adenosquamous Cell Carcinoma'}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05179239,"{'Official Title': 'A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ≥ 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}","{'Arm - Disease - Indication': 'First-Line Persistent, Recurrent, or Metastatic Cervical Adenosquamous Cell Carcinoma'}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05179239,"{'Official Title': 'A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ≥ 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}","{'Arm - Disease - Indication': 'First-Line Persistent, Recurrent, or Metastatic Cervical Adenosquamous Cell Carcinoma'}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04732494,"{'Official Title': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma', 'Brief Summary': 'A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.', 'Condition': 'Esophageal Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.\nHave PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.\nHave measurable disease as assessed by RECIST v1.1.\nHave confirmed PD-L1 TAP ≥ 10% in tumor tissues tested by the central lab.\nEastern Cooperative Oncology Group Performance Status score of 0 or 1.'}","{'Arm - Disease - Indication': 'Second-Line Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma'}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04732494,"{'Official Title': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma', 'Brief Summary': 'A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.', 'Condition': 'Esophageal Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.\nHave PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.\nHave measurable disease as assessed by RECIST v1.1.\nHave confirmed PD-L1 TAP ≥ 10% in tumor tissues tested by the central lab.\nEastern Cooperative Oncology Group Performance Status score of 0 or 1.'}","{'Arm - Disease - Indication': 'Second-Line Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma'}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05299255,"{'Official Title': 'An Open, Single-center Phase II Clinical Study of Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer', 'Brief Summary': 'SCLC has a very high degree of malignancy, and 60% to 70% of patients are diagnosed as extensive stage. The median survival of patients with limited-stage disease is about 15-20 months, and the median OS of patients with extensive-stage disease is about 8-13 months, and the 2-year and 5-year survival rates are about 5% and 1-2%, respectively. However, although the initial treatment has a high effective rate, most patients relapse or progress within 1 year, and the effect of re-treatment is poor and the prognosis is poor. The effective rate of SCLC second-line treatment is only 10-25%, and the median survival time is less than 6 months. After the third and fourth lines, there are almost no recognized treatment options. Therefore, improving the second-line treatment of SCLC has always been a difficult clinical problem, and new drugs are urgently needed to be explored. In small cell lung cancer, based on phase II clinical trials, paclitaxel is currently recommended by NCCN guidelines for subsequent systemic therapy in patients who relapse 6 months or less after initial therapy. Utidelone (UTD1) is an epothilone derivative with a similar mechanism of action to taxanes, but a completely different molecular structure.', 'Condition': 'SCLC, Extensive Stage', 'Detailed Description': 'Compared with paclitaxel, epothilones has higher water solubility and toxicity tolerance, and fewer side effects, these findings suggest that utidron may have better antitumor activity against small cell lung cancer. Therefore, to prospectively observe the treatment of extensive-stage small cell lung cancer with failure of second-line or above chemotherapy and receive Utilidron, so as to understand the efficacy, safety and tolerability of Utilidron in the third-line and above treatment of small cell lung cancer, which is a small Post-line treatment of cell lung cancer provides new directions and treatment options.\n\nThis study is an open, single-center phase II clinical study. Small cell lung cancer patients with disease progression or recurrence after second-line therapy or above, receive Utilidron injection. Utilidron injection 40mg/m2/d d1-5 q3w was administered until disease progression (PD), intolerable toxicity, initiation of new antitumor therapy, loss to follow-up, death, and the investigator decided to be tested Subjects who withdraw from the study treatment or the subject/their legal representative requests to withdraw from the study (whichever occurs first). After consultation with the sponsor, the patient will determine whether the treatment can be continued, observe and evaluate the preliminary efficacy and safety.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically diagnosed small cell lung cancer (except for small cell lung cancer mixed with other pathological types);\nThe expected survival period is not less than 3 months;\nSecond-line therapy (excluding maintenance therapy) and above with disease progression or recurrence of small cell lung cancer;\nPatients who have not received chemotherapy, radiotherapy, surgery, targeted therapy and immunotherapy within 4 weeks before enrollment;\nAge 18-75 years old, physical condition score ECOG 0-1 points;\nAt least one target lesion measurable by imaging within 3 weeks before enrollment, ordinary CT scan ≥ 20 mm, spiral CT scan diameter ≥ 10 mm (lymph node short diameter ≥ 15 mm);\nAsymptomatic brain metastases, or patients with stable disease for more than 4 weeks after brain metastases treatment;\nNeurological lesions should be less than grade 2 within 4 weeks before enrollment (NCI CTC4.03);\nRoutine blood and blood biochemical tests were basically normal within 1 week before enrollment (based on the normal value of the research center laboratory, no blood transfusion within 14 days before screening, and no rhG-CSF was used):\nBlood routine: HGB≥9g/dL; ANC≥1.5×109/L; PLT≥80×109/L; Blood biochemistry (without ALB infusion within 14 days): bilirubin <1.5 times the upper limit of normal, ALT and AST ≤2.5 times the upper limit of normal (if liver metastases exist, bilirubin ≤3 times the upper limit of normal, ALT and AST≤3 times the upper limit of normal) 5 times the upper limit of normal), serum Cr≤1.5 times the upper limit of normal or endogenous creatinine clearance ≥45 mL/min (Cockcroft-Gault formula);\n\nThose who have no major organ dysfunction and no concomitant heart disease;\nFemales of childbearing age, including those who are in menopause but have not reached postmenopausal state (natural amenorrhea for 12 consecutive months) and who have not received sterilization and ovarian and/or hysterectomy, must have a blood pregnancy test within 7 days before the first'}",{'Arm - Disease - Indication': 'Third-Line or Above Treatment of Recurrent Small cell lung cancer (except for small cell lung cancer mixed with other pathological types)'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04269200,"{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)\n', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n', 'Condition': 'Endometrial Neoplasms\n', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer\n\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}",{'Arm - Disease - Indication': 'Newly Diagnosed Advanced or Recurrent Endometrial Neoplasm'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04269200,"{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)\n', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n', 'Condition': 'Endometrial Neoplasms\n', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer\n\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}",{'Arm - Disease - Indication': 'Newly Diagnosed Advanced or Recurrent Endometrial Neoplasm'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04269200,"{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)\n', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n', 'Condition': 'Endometrial Neoplasms\n', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer\n\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}",{'Arm - Disease - Indication': 'Newly Diagnosed Advanced or Recurrent Endometrial Neoplasm'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04916613,"{'Official Title': 'A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents', 'Brief Summary': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.', 'Condition': 'Prostate Cancer Metastatic', 'Detailed Description': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 patients who will be randomized (1:1) to receive either: (i) Experimental arm: ADT + darolutamide 600 mg po bid, or (ii) Control arm: ADT + placebo po bid. Response to treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (Scher, 2016). Treatment will be continued until radiographic disease progression. Treatment may also be terminated at the initiative of either the patient or the investigator for any reason that would be beneficial to the patient, including: unacceptable toxicity, intercurrent conditions that preclude continuation of treatment, or patient request. Following treatment discontinuation patients will enter the follow-up period and will be monitored for up to 10 years with regards to survival status, subsequent antineoplastic treatments and the status of ongoing adverse events (AEs) and/or new investigational product related AEs.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSigned a written informed consent form prior to any trial specific procedures.\r\nMen with histologically or cytologically confirmed adenocarcinoma of the prostate.\r\nAged ≥18 years old at the time of signing informed consent.\r\nDe novo metastatic disease defined by clinical or radiological evidence of metastases.\r\n\r\nNote: For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\r\n\r\nAt least one extra-pelvic lymph node ≥2 cm\r\nAt least one extra-pelvic lymph node ≥1 cm if the patients also have at least one pelvic lymph node ≥2 cm\r\nMeasurable disease or bone lesions that are evaluable according to PCWG3 criteria.\r\nIneligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:\r\n\r\nActivities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4/5;\r\n4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4;\r\nA Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire;\r\nBody mass index (BMI) ≤21 kg/m² and/or >10% weight loss in the last 6 months;\r\nTimed up and go test (TUG) >14 sec.\r\nAdequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L and platelets ≥80 x10⁹/L.\r\nAdequate liver function: alanine aminotransferase (ALT) <2 x upper limit of normal (ULN) and bilirubin <1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). For patients with documented liver metastasis, ALT <5 x ULN is acceptable.\r\nAdequate renal function: calculated creatinine clearance >30 ml/min (using the Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology Collaboration [CKD EPI) method).\r\nFor sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment.\r\nAffiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\r\nWilling and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.'}",{'Arm - Disease - Indication': 'Metastatic Castration-Naive Prostate Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04916613,"{'Official Title': 'A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents', 'Brief Summary': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.', 'Condition': 'Prostate Cancer Metastatic', 'Detailed Description': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 patients who will be randomized (1:1) to receive either: (i) Experimental arm: ADT + darolutamide 600 mg po bid, or (ii) Control arm: ADT + placebo po bid. Response to treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (Scher, 2016). Treatment will be continued until radiographic disease progression. Treatment may also be terminated at the initiative of either the patient or the investigator for any reason that would be beneficial to the patient, including: unacceptable toxicity, intercurrent conditions that preclude continuation of treatment, or patient request. Following treatment discontinuation patients will enter the follow-up period and will be monitored for up to 10 years with regards to survival status, subsequent antineoplastic treatments and the status of ongoing adverse events (AEs) and/or new investigational product related AEs.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSigned a written informed consent form prior to any trial specific procedures.\r\nMen with histologically or cytologically confirmed adenocarcinoma of the prostate.\r\nAged ≥18 years old at the time of signing informed consent.\r\nDe novo metastatic disease defined by clinical or radiological evidence of metastases.\r\n\r\nNote: For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\r\n\r\nAt least one extra-pelvic lymph node ≥2 cm\r\nAt least one extra-pelvic lymph node ≥1 cm if the patients also have at least one pelvic lymph node ≥2 cm\r\nMeasurable disease or bone lesions that are evaluable according to PCWG3 criteria.\r\nIneligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:\r\n\r\nActivities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4/5;\r\n4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4;\r\nA Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire;\r\nBody mass index (BMI) ≤21 kg/m² and/or >10% weight loss in the last 6 months;\r\nTimed up and go test (TUG) >14 sec.\r\nAdequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L and platelets ≥80 x10⁹/L.\r\nAdequate liver function: alanine aminotransferase (ALT) <2 x upper limit of normal (ULN) and bilirubin <1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). For patients with documented liver metastasis, ALT <5 x ULN is acceptable.\r\nAdequate renal function: calculated creatinine clearance >30 ml/min (using the Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology Collaboration [CKD EPI) method).\r\nFor sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment.\r\nAffiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\r\nWilling and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.'}",{'Arm - Disease - Indication': 'Metastatic Castration-Naive Prostate Cancer\n'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03740165,"{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': ""Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}",{'Arm - Disease - Indication': 'First-Line BRCA Non-mutated Advanced Epithelial Ovarian Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03740165,"{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': ""Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}",{'Arm - Disease - Indication': 'First-Line BRCA Non-mutated Advanced Epithelial Ovarian Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03740165,"{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': ""Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}",{'Arm - Disease - Indication': 'First-Line BRCA Non-mutated Advanced Epithelial Ovarian Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05580562,"{'Official Title': 'ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.', 'Condition': 'Glioma', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nAble to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\r\nBody weight ≥ 10 kg at time of randomization.\r\nHistologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS] in a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory). [Site to provide (as available): ≥ 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]\r\nCompleted standard frontline radiotherapy within 2 to 6 weeks prior to randomization. Standard frontline radiotherapy is defined as a dose of 54 to 60 Gy at 1.8 to 2.2 Gy/fraction. Radiotherapy must be initiated within 12 weeks from initial diagnosis of H3 K27M-mutant diffuse glioma and within 8 weeks of most recent surgical resection/biopsy.\r\nKarnofsky Performance Status or Lansky Performance Status ≥ 70 at time of randomization.\r\nStable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid).""}",{'Arm - Disease - Indication': ' Newly diagnosed H3 K27M-mutant diffuse glioma '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05580562,"{'Official Title': 'ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.', 'Condition': 'Glioma', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nAble to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\r\nBody weight ≥ 10 kg at time of randomization.\r\nHistologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS] in a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory). [Site to provide (as available): ≥ 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]\r\nCompleted standard frontline radiotherapy within 2 to 6 weeks prior to randomization. Standard frontline radiotherapy is defined as a dose of 54 to 60 Gy at 1.8 to 2.2 Gy/fraction. Radiotherapy must be initiated within 12 weeks from initial diagnosis of H3 K27M-mutant diffuse glioma and within 8 weeks of most recent surgical resection/biopsy.\r\nKarnofsky Performance Status or Lansky Performance Status ≥ 70 at time of randomization.\r\nStable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid).""}",{'Arm - Disease - Indication': ' Newly diagnosed H3 K27M-mutant diffuse glioma '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05580562,"{'Official Title': 'ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.', 'Condition': 'Glioma', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nAble to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\r\nBody weight ≥ 10 kg at time of randomization.\r\nHistologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS] in a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory). [Site to provide (as available): ≥ 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]\r\nCompleted standard frontline radiotherapy within 2 to 6 weeks prior to randomization. Standard frontline radiotherapy is defined as a dose of 54 to 60 Gy at 1.8 to 2.2 Gy/fraction. Radiotherapy must be initiated within 12 weeks from initial diagnosis of H3 K27M-mutant diffuse glioma and within 8 weeks of most recent surgical resection/biopsy.\r\nKarnofsky Performance Status or Lansky Performance Status ≥ 70 at time of randomization.\r\nStable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid).""}",{'Arm - Disease - Indication': ' Newly diagnosed H3 K27M-mutant diffuse glioma '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04853043,"{'Official Title': 'APK Mutant: A Single Arm Phase II Study of Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'A prospective, multi-center, phase II study of 21 patients to evaluate the efficacy of the EGFR inhibitor, Cetuximab in patients with mCRC harboring APC, TP53 and RAS mutations.', 'Condition': 'Colorectal Cancer', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nMale or female subject aged ≥ 18 years.\nHistologically confirmed metastatic colorectal adenocarcinoma with mutant APC, TP53 and KRAS genes as determined by the local CLIA-certified laboratory are eligible. All RAS mutations are allowed (KRAS, NRAS, HRAS). Patients with wild type KRAS, APC or TP53 are ineligible..\nProgression or unwanted toxicities on atleast 2 prior lines of treatment including 5-Flourouracil, oxaliplatin and irinotecan based regimen\nStudy participants must have measurable disease by RECIST 1.1 criteria by CT or MRI.\nECOG Performance Status ≤ 2.\nStudy participants with treated and/or stable brain metastases are allowed\nStudy participants must have anticipated life expectancy > 3 months\nAdequate organ function as defined as:\n\nHematologic:\n\nAbsolute neutrophil count (ANC) ≥ ≥1000/µL\nPlatelet count ≥ 100,000/mm3\nHemoglobin ≥ 9 g/dL\nHepatic:\n\nSerum Bilirubin ≤ 2 x ULN or ≤ 3 x ULN for subjects with Gilbert's syndrome\nAspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases)\nRenal:\n\nSerum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed)\nFor female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\nWomen < 50 years of age:\n\nAmenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\nLuteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\nUnderwent surgical sterilization (bilateral oophorectomy or hysterectomy).\nWomen ≥ 50 years of age:\n\nAmenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\nHad radiation-induced menopause with last menses >1 year ago; or\nHad chemotherapy-induced menopause with last menses >1 year ago; or\nUnderwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\nFemale subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for atleast 12 months after last study treatment administration.\nMale subjects must agree to use a condom during intercourse for the duration of study therapy and for atleast 12 months after last study treatment administration.\nRecovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator.\nAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.""}","{'Arm - Disease - Indication': 'Third Line Mutant APC, TP53 and RAS Refractory Metastatic Colorectal Adenocarcinoma'}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05987358,"{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation.\n', 'Brief Summary': 'This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma.\n', 'Condition': 'Biliary Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nage ≥18 years old, ≤75 years old (calculated on the date of signing the informed consent); Eastern Cooperative oncology Group (ECOG) score 0 ~ 2.\nTumor tissue samples must be provided for genetic testing (10 puncture paraffin sections or 5 surgical paraffin sections).\nPatients with viral hepatitis: Patients should be treated symptomatically until the virus is stable before enrollment, and treatment should be maintained during the experimental period.\nThe main organs have good functions.\nMeet the criteria for advanced biliary carcinoma:\n\ncholangiocarcinoma histologically or cytologically confirmed\nLocally advanced, relapsing, and/or metastatic disease that is not operable and has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors V1.1 (RECIST 1.1) criteria.\nPrevious gemcitabine and fluorouracil (and/or platinum-based) drug therapy failed.\nWomen of reproductive age should agree that they must use effective contraception during the study period and for 6 months after the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period.\nThe subjects voluntarily joined the study, signed the informed consent, and the compliance was good.'}",{'Arm - Disease - Indication': 'IDH1 Mutated Unresectable Locally Advanced Relapsing and/or Metastatic Biliary Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05987358,"{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation.\n', 'Brief Summary': 'This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma.\n', 'Condition': 'Biliary Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nage ≥18 years old, ≤75 years old (calculated on the date of signing the informed consent); Eastern Cooperative oncology Group (ECOG) score 0 ~ 2.\nTumor tissue samples must be provided for genetic testing (10 puncture paraffin sections or 5 surgical paraffin sections).\nPatients with viral hepatitis: Patients should be treated symptomatically until the virus is stable before enrollment, and treatment should be maintained during the experimental period.\nThe main organs have good functions.\nMeet the criteria for advanced biliary carcinoma:\n\ncholangiocarcinoma histologically or cytologically confirmed\nLocally advanced, relapsing, and/or metastatic disease that is not operable and has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors V1.1 (RECIST 1.1) criteria.\nPrevious gemcitabine and fluorouracil (and/or platinum-based) drug therapy failed.\nWomen of reproductive age should agree that they must use effective contraception during the study period and for 6 months after the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period.\nThe subjects voluntarily joined the study, signed the informed consent, and the compliance was good.'}",{'Arm - Disease - Indication': 'IDH1 Mutated Unresectable Locally Advanced Relapsing and/or Metastatic Biliary Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05457959,"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': ""This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n"", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}",{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05457959,"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': ""This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n"", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}",{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05457959,"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': ""This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n"", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}",{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05457959,"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': ""This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n"", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}",{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05457959,"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': ""This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n"", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}",{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05457959,"{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': ""This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n"", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}",{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02773524,"{'Official Title': 'A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)\n', 'Brief Summary': 'A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)\n', 'Condition': 'Gastro-Oesophageal Cancer\n', 'Detailed Description': 'Purpose:\n\nThe purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma.\n\nWho is it for:\n\nYou may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy.\n\nTrial Details:\n\nParticipants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.', 'Inclusion Criteria': 'Inclusion Criteria\n\nAdults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which:\n\nhas arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and\nis of adenocarcinoma or undifferentiated carcinoma histology , and\nis evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and\nhas failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue.\n\nNote: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment.\n\nHER2-positive participants must have received trastuzumab.\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\nAbility to swallow oral medication.\nAdequate bone marrow function (Platelets ≥100x109/L; Absolute Neutrophil Count (ANC) ≥1.5x109/L and Haemoglobin ≥ 9.0g/dL).\nAdequate renal function (Creatinine clearance >50 ml/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine ≤1.5 x Upper Limit of Normal (ULN).\nAdequate liver function (Serum total bilirubin ≤1.5 x ULN, and INR ≤ 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤2.5 x ULN (≤ 5 x ULN for participants with liver metastases)). Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists.\nAdequate cardiac function (Left Ventricular Ejection Fraction (LVEF) ≥ 50% or above the lower limit of normal (LLN) for the Institution (whichever is lower). Cardiac function should be assessed within 3 months prior to randomisation, but after completion of any anthracycline-containing chemotherapy.\nWilling and able to comply with all study requirements, including treatment, timing, and/or nature of required assessments and follow-up.\nStudy treatment both planned and able to start within 7 days after randomisation (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday).\nSigned, written informed consent.'}",{'Arm - Disease - Indication': 'Adult Metastatic or Locally Recurrent Refractory Gastro-Oesophageal Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02773524,"{'Official Title': 'A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)\n', 'Brief Summary': 'A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)\n', 'Condition': 'Gastro-Oesophageal Cancer\n', 'Detailed Description': 'Purpose:\n\nThe purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma.\n\nWho is it for:\n\nYou may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy.\n\nTrial Details:\n\nParticipants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.', 'Inclusion Criteria': 'Inclusion Criteria\n\nAdults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which:\n\nhas arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and\nis of adenocarcinoma or undifferentiated carcinoma histology , and\nis evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and\nhas failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue.\n\nNote: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment.\n\nHER2-positive participants must have received trastuzumab.\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\nAbility to swallow oral medication.\nAdequate bone marrow function (Platelets ≥100x109/L; Absolute Neutrophil Count (ANC) ≥1.5x109/L and Haemoglobin ≥ 9.0g/dL).\nAdequate renal function (Creatinine clearance >50 ml/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine ≤1.5 x Upper Limit of Normal (ULN).\nAdequate liver function (Serum total bilirubin ≤1.5 x ULN, and INR ≤ 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤2.5 x ULN (≤ 5 x ULN for participants with liver metastases)). Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists.\nAdequate cardiac function (Left Ventricular Ejection Fraction (LVEF) ≥ 50% or above the lower limit of normal (LLN) for the Institution (whichever is lower). Cardiac function should be assessed within 3 months prior to randomisation, but after completion of any anthracycline-containing chemotherapy.\nWilling and able to comply with all study requirements, including treatment, timing, and/or nature of required assessments and follow-up.\nStudy treatment both planned and able to start within 7 days after randomisation (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday).\nSigned, written informed consent.'}",{'Arm - Disease - Indication': 'Adult Metastatic or Locally Recurrent Refractory Gastro-Oesophageal Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05270044,"{'Official Title': 'Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group', 'Brief Summary': 'The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).', 'Condition': 'Melanoma', 'Detailed Description': 'This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial.\r\n\r\nParticipants with completely resected cutaneous melanoma and documented BRAF V600E/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between:\r\n\r\nstage IIB (i.e., pT3b or pT4a)\r\nstage IIC (i.e., pT4b).\r\nThe long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nPre-Screening\r\n\r\nMale or female ≥ 18 years of age;\r\nSurgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa;\r\nSentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma.\r\nSentinel node (SN) staged node negative (pN0);\r\nAvailable tumour sample for central determination of the BRAF V600E/K mutation.\r\nScreening\r\n\r\nMelanoma confirmed centrally to be BRAF V600E/K mutation-positive;\r\nParticipant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1);\r\nNo more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;\r\nRecovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);\r\nECOG performance status of 0 or 1;\r\nAdequate haematological function as defined as Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L and Hemoglobin\r\n\r\n≥ 9.0 g/dL;\r\n\r\nAdequate renal function as defined as Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min;\r\nAdequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;\r\nAdequate hepatic function as defined as Serum total bilirubin ≤ 1.5 x ULN and < 2 mg/dL, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN;\r\nAdequate cardiac function as defined as LVEF ≥ 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value ≤ 480 msec and no history of QT syndrome;\r\nAdequate coagulation function, defined as INR ≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range;\r\nNegative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;\r\nFemale patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for ≥30 days after last administration.""}",{'Arm - Disease - Indication': 'Fully Resected BRAF V600E-Positive Stage IIB or Stage IIC Cutaneous Melanoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05270044,"{'Official Title': 'Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group', 'Brief Summary': 'The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).', 'Condition': 'Melanoma', 'Detailed Description': 'This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial.\r\n\r\nParticipants with completely resected cutaneous melanoma and documented BRAF V600E/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between:\r\n\r\nstage IIB (i.e., pT3b or pT4a)\r\nstage IIC (i.e., pT4b).\r\nThe long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nPre-Screening\r\n\r\nMale or female ≥ 18 years of age;\r\nSurgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa;\r\nSentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma.\r\nSentinel node (SN) staged node negative (pN0);\r\nAvailable tumour sample for central determination of the BRAF V600E/K mutation.\r\nScreening\r\n\r\nMelanoma confirmed centrally to be BRAF V600E/K mutation-positive;\r\nParticipant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1);\r\nNo more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;\r\nRecovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);\r\nECOG performance status of 0 or 1;\r\nAdequate haematological function as defined as Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L and Hemoglobin\r\n\r\n≥ 9.0 g/dL;\r\n\r\nAdequate renal function as defined as Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min;\r\nAdequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;\r\nAdequate hepatic function as defined as Serum total bilirubin ≤ 1.5 x ULN and < 2 mg/dL, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN;\r\nAdequate cardiac function as defined as LVEF ≥ 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value ≤ 480 msec and no history of QT syndrome;\r\nAdequate coagulation function, defined as INR ≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range;\r\nNegative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;\r\nFemale patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for ≥30 days after last administration.""}",{'Arm - Disease - Indication': 'Fully Resected BRAF V600E-Positive Stage IIB or Stage IIC Cutaneous Melanoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04322539,"{'Official Title': 'A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.', 'Condition': 'Metastatic Colorectal Cancer, Metastatic Colon Cancer', 'Detailed Description': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib in combination with BSC versus placebo in combination with BSC in metastatic colorectal cancer participants who have progressed on, or were intolerant to, chemotherapy, anti-VEGF and anti-EGFR biologics, and TAS-102 or regorafenib. Participants with MSI-H/MMR deficient tumors must have also received an immune checkpoint inhibitor if approved and available and if deemed appropriate. Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available and if deemed appropriate.\n\nMetastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nProvide written informed consent;\nAge ≥18 years;\nHistologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines;\nParticipants must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Participants are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Participants who have been treated with both TAS-102 and regorafenib are permitted. Participants must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy;\nParticipants with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the participant's country unless the patient is ineligible for treatment with a checkpoint inhibitor;\nParticipants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Participants who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible;\nBody weight ≥40kg;\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1;\nHave measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions;\nExpected survival >12 weeks.\nFor female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male participants involved in this clinical trial if they have a partner of childbirth potential, and male participants must always use a condom.\nParticipants with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the participant's home country unless the patient is ineligible for treatment with a BRAF inhibitor.""}",{'Arm - Disease - Indication': 'Metastatic Colorectal Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04322539,"{'Official Title': 'A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.', 'Condition': 'Metastatic Colorectal Cancer, Metastatic Colon Cancer', 'Detailed Description': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib in combination with BSC versus placebo in combination with BSC in metastatic colorectal cancer participants who have progressed on, or were intolerant to, chemotherapy, anti-VEGF and anti-EGFR biologics, and TAS-102 or regorafenib. Participants with MSI-H/MMR deficient tumors must have also received an immune checkpoint inhibitor if approved and available and if deemed appropriate. Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available and if deemed appropriate.\n\nMetastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nProvide written informed consent;\nAge ≥18 years;\nHistologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines;\nParticipants must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Participants are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Participants who have been treated with both TAS-102 and regorafenib are permitted. Participants must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy;\nParticipants with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the participant's country unless the patient is ineligible for treatment with a checkpoint inhibitor;\nParticipants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Participants who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible;\nBody weight ≥40kg;\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1;\nHave measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions;\nExpected survival >12 weeks.\nFor female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male participants involved in this clinical trial if they have a partner of childbirth potential, and male participants must always use a condom.\nParticipants with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the participant's home country unless the patient is ineligible for treatment with a BRAF inhibitor.""}",{'Arm - Disease - Indication': 'Metastatic Colorectal Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04844528,"{'Official Title': 'Randomized Phase 2 Studying the Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC)\n', 'Brief Summary': 'This is a randomized, phase II, double-blind, placebo-controlled trial with planned crossover to the intervention arm after 1 year.\n\nConsenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive either oral nicotinamide 500 mg twice daily (BID) for 1 year or oral placebo 1 tablet twice daily for 1 year. Patients will be stratified according to CLL therapy and the number of prior NMSC. At the end of 1 year, patients will undergo dermatologic examination and the number of new NMSC will be quantified. The number of patients who develop new NMSC in each arm will be documented. At this time, patients will be unblinded and all patients will receive Nicotinamide 500 mg BID for an additional year. At the end of this second year, patients will again undergo dermatologic examination, and the number of new NMSC will be quantified. The number of patients who develop NMSC will be documented. Skin biopsies will be taken for correlative studies.\n\nEnrollment will be split into two parts separated by an interim analysis. Part 1 will accrue 40 patients: 20 to each arm. After 40 patients have completed their 12 month visit an interim futility analysis will be conducted prior to recruiting more patients. The study will stop if the difference in the number of patients with NMSC between control and treatment arms is 0 or less (i.e., absolutely no evidence that the treatment is better than control). If the trial is not stopped, the investigators will proceed with Part 2 and recruit 46 more patients.\n\n', 'Condition': 'Chronic Lymphocytic Leukemia\n', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nMale or female subject aged ≥ 18 years.\nConfirmed diagnosis of CLL or small lymphocytic leukemia (SLL) per iwCLL 2018 criteria.\nHistory of ≥1 non-melanoma skin cancer (NMSC) diagnosed within the last 5 years\nAdequate liver function as defined as:\n\nTotal Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)\n\n---Subjects with a known diagnosis of Gilbert's Syndrome: direct bilirubin ≤ 1.5x ULN\n\nAST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN\nFor female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n--Women < 50 years of age:\n\nAmenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\nLuteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\nUnderwent surgical sterilization (bilateral oophorectomy or hysterectomy).\nWomen ≥ 50 years of age:\n\nAmenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\nHad radiation-induced menopause with last menses >1 year ago; or\nHad chemotherapy-induced menopause with last menses >1 year ago; or\nUnderwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\nFemale subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.""}",{'Arm - Disease - Indication': 'Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers\n'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04844528,"{'Official Title': 'Randomized Phase 2 Studying the Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC)\n', 'Brief Summary': 'This is a randomized, phase II, double-blind, placebo-controlled trial with planned crossover to the intervention arm after 1 year.\n\nConsenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive either oral nicotinamide 500 mg twice daily (BID) for 1 year or oral placebo 1 tablet twice daily for 1 year. Patients will be stratified according to CLL therapy and the number of prior NMSC. At the end of 1 year, patients will undergo dermatologic examination and the number of new NMSC will be quantified. The number of patients who develop new NMSC in each arm will be documented. At this time, patients will be unblinded and all patients will receive Nicotinamide 500 mg BID for an additional year. At the end of this second year, patients will again undergo dermatologic examination, and the number of new NMSC will be quantified. The number of patients who develop NMSC will be documented. Skin biopsies will be taken for correlative studies.\n\nEnrollment will be split into two parts separated by an interim analysis. Part 1 will accrue 40 patients: 20 to each arm. After 40 patients have completed their 12 month visit an interim futility analysis will be conducted prior to recruiting more patients. The study will stop if the difference in the number of patients with NMSC between control and treatment arms is 0 or less (i.e., absolutely no evidence that the treatment is better than control). If the trial is not stopped, the investigators will proceed with Part 2 and recruit 46 more patients.\n\n', 'Condition': 'Chronic Lymphocytic Leukemia\n', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nMale or female subject aged ≥ 18 years.\nConfirmed diagnosis of CLL or small lymphocytic leukemia (SLL) per iwCLL 2018 criteria.\nHistory of ≥1 non-melanoma skin cancer (NMSC) diagnosed within the last 5 years\nAdequate liver function as defined as:\n\nTotal Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)\n\n---Subjects with a known diagnosis of Gilbert's Syndrome: direct bilirubin ≤ 1.5x ULN\n\nAST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN\nFor female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n--Women < 50 years of age:\n\nAmenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\nLuteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\nUnderwent surgical sterilization (bilateral oophorectomy or hysterectomy).\nWomen ≥ 50 years of age:\n\nAmenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\nHad radiation-induced menopause with last menses >1 year ago; or\nHad chemotherapy-induced menopause with last menses >1 year ago; or\nUnderwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\nFemale subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.""}",{'Arm - Disease - Indication': 'Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers\n'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03981614,"{'Official Title': 'Combination of MEK Inhibitor Binimetinib and CDK4/6 Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers\n', 'Brief Summary': 'This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer.\n', 'Condition': 'Metastatic Colorectal Carcinoma\nStage IV Colorectal Cancer AJCC v8\nStage IVA Colorectal Cancer AJCC v8\nStage IVB Colorectal Cancer AJCC v8\nStage IVC Colorectal Cancer AJCC v8\nUnresectable Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. The primary objective is to compare the progression-free survival (PFS) between those randomized to palbociclib/binimetinib and those randomized to trifluridine and tipiracil hydrochloride (TAS-102) in patients with refractory KRAS- or NRAS-mutant metastatic colorectal cancer (CRC).\n\nSECONDARY OBJECTIVES:\n\nI. To compare the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nII. To compare the overall survival (OS) between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nIII. To determine the safety and tolerability of the recommended phase II dose of palbociclib in combination with binimetinib in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nCORRELATIVE RESEARCH OBJECTIVES:\n\nI. To determine the tumor mutational profiles that characterize groups of patients that predict for response or resistance to combination of palbociclib/binimetinib.\n\nII. To determine the correlation between circulating tumor deoxyribonucleic acid (DNA) and tumor response or resistance to therapy with palbociclib/binimetinib or TAS-102.\n\nIII. To determine the association between Consensus Molecular Subtype based on gene expression profiling and response or resistance to combination of palbociclib/binimetinib.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and palbociclib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\n\nAfter completion of study treatment, patients are followed up within 30-37 days and then every 12 weeks for up to 24 months.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistological confirmation of colorectal cancer that is metastatic and/or unresectable\nDocumented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\nMeasurable disease\nEastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\nPreviously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nAbsolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nPlatelet count >= 75 x 10^9/L without transfusions (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nHemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nAspartate transaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nNegative serum beta-human chorionic gonadotropin (B-HCG) pregnancy test done =< 7 days prior to registration/randomization for women of childbearing potential only\nAble to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nAble and willing to provide informed written consent and able to comply with protocol requirement\nAble and willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nNOTE: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nWilling to provide blood and tissue samples for mandatory correlative research purposes\nPatient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)\nCROSSOVER INCLUSION CRITERIA: Histological confirmation of colorectal cancer that is metastatic and/or unresectable\nCROSSOVER INCLUSION CRITERIA: Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a CLIA-certified laboratory\nCROSSOVER INCLUSION CRITERIA: Measurable disease\nCROSSOVER INCLUSION CRITERIA: ECOG performance status (PS) of 0 or 1\nCROSSOVER INCLUSION CRITERIA: Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nCROSSOVER INCLUSION CRITERIA: ANC >= 1.5 x 10^9/L (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Platelet count >= 75 x 10^9/L without transfusion (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Hgb >= 9 g/dL (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Total bilirubin =< 1.5 x ULN (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: AST and ALT =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Negative serum beta-HCG pregnancy test done =< 7 days prior to re-registration for women of childbearing potential only\nCROSSOVER INCLUSION CRITERIA: Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nCROSSOVER INCLUSION CRITERIA: Able and willing to provide informed written consent and able to comply with protocol requirements\nCROSSOVER INCLUSION CRITERIA: Able and willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nNOTE: During the Active Monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nCROSSOVER INCLUSION CRITERIA: Willing to provide blood samples for mandatory correlative research purposes\nCROSSOVER INCLUSION CRITERIA: Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)'}",{'Arm - Disease - Indication': 'KRAS/NRAS Positive Metastatic Refractory Unresectable Colorectal Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03981614,"{'Official Title': 'Combination of MEK Inhibitor Binimetinib and CDK4/6 Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers\n', 'Brief Summary': 'This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer.\n', 'Condition': 'Metastatic Colorectal Carcinoma\nStage IV Colorectal Cancer AJCC v8\nStage IVA Colorectal Cancer AJCC v8\nStage IVB Colorectal Cancer AJCC v8\nStage IVC Colorectal Cancer AJCC v8\nUnresectable Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. The primary objective is to compare the progression-free survival (PFS) between those randomized to palbociclib/binimetinib and those randomized to trifluridine and tipiracil hydrochloride (TAS-102) in patients with refractory KRAS- or NRAS-mutant metastatic colorectal cancer (CRC).\n\nSECONDARY OBJECTIVES:\n\nI. To compare the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nII. To compare the overall survival (OS) between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nIII. To determine the safety and tolerability of the recommended phase II dose of palbociclib in combination with binimetinib in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nCORRELATIVE RESEARCH OBJECTIVES:\n\nI. To determine the tumor mutational profiles that characterize groups of patients that predict for response or resistance to combination of palbociclib/binimetinib.\n\nII. To determine the correlation between circulating tumor deoxyribonucleic acid (DNA) and tumor response or resistance to therapy with palbociclib/binimetinib or TAS-102.\n\nIII. To determine the association between Consensus Molecular Subtype based on gene expression profiling and response or resistance to combination of palbociclib/binimetinib.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and palbociclib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\n\nAfter completion of study treatment, patients are followed up within 30-37 days and then every 12 weeks for up to 24 months.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistological confirmation of colorectal cancer that is metastatic and/or unresectable\nDocumented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\nMeasurable disease\nEastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\nPreviously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nAbsolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nPlatelet count >= 75 x 10^9/L without transfusions (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nHemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nAspartate transaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nNegative serum beta-human chorionic gonadotropin (B-HCG) pregnancy test done =< 7 days prior to registration/randomization for women of childbearing potential only\nAble to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nAble and willing to provide informed written consent and able to comply with protocol requirement\nAble and willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nNOTE: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nWilling to provide blood and tissue samples for mandatory correlative research purposes\nPatient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)\nCROSSOVER INCLUSION CRITERIA: Histological confirmation of colorectal cancer that is metastatic and/or unresectable\nCROSSOVER INCLUSION CRITERIA: Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a CLIA-certified laboratory\nCROSSOVER INCLUSION CRITERIA: Measurable disease\nCROSSOVER INCLUSION CRITERIA: ECOG performance status (PS) of 0 or 1\nCROSSOVER INCLUSION CRITERIA: Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nCROSSOVER INCLUSION CRITERIA: ANC >= 1.5 x 10^9/L (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Platelet count >= 75 x 10^9/L without transfusion (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Hgb >= 9 g/dL (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Total bilirubin =< 1.5 x ULN (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: AST and ALT =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Negative serum beta-HCG pregnancy test done =< 7 days prior to re-registration for women of childbearing potential only\nCROSSOVER INCLUSION CRITERIA: Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nCROSSOVER INCLUSION CRITERIA: Able and willing to provide informed written consent and able to comply with protocol requirements\nCROSSOVER INCLUSION CRITERIA: Able and willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nNOTE: During the Active Monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nCROSSOVER INCLUSION CRITERIA: Willing to provide blood samples for mandatory correlative research purposes\nCROSSOVER INCLUSION CRITERIA: Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)'}",{'Arm - Disease - Indication': 'KRAS/NRAS Positive Metastatic Refractory Unresectable Colorectal Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05920356,"{'Official Title': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'Brief Summary': 'The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\r\nNo history of systemic anticancer therapy in metastatic/non-curable settings\r\nEastern Cooperative Oncology Group (ECOG) ≤ 1'}","{'Arm - Disease - Indication': 'Frontline Stage IV or Advanced Stage IIIB/\u200bC Nonsquamous Non-Small Cell Lung Cancer, Negative for PD-L1, and Positive for KRAS p.G12C '}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05920356,"{'Official Title': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'Brief Summary': 'The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\r\nNo history of systemic anticancer therapy in metastatic/non-curable settings\r\nEastern Cooperative Oncology Group (ECOG) ≤ 1'}","{'Arm - Disease - Indication': 'Frontline Stage IV or Advanced Stage IIIB/\u200bC Nonsquamous Non-Small Cell Lung Cancer, Negative for PD-L1, and Positive for KRAS p.G12C '}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02642042,"{'Official Title': 'A Phase II Trial of Trametinib With Docetaxel in Patients With KRAS Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies', 'Brief Summary': 'This phase II trial studies how well trametinib and docetaxel work in treating patients with stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come back. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib with docetaxel may work better in treating non-small cell lung cancer.', 'Condition': 'Recurrent Lung Non-Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVES:\r\n\r\nI. To evaluate the response rate (confirmed and unconfirmed) to trametinib plus docetaxel in the entire study population of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive non-small cell lung cancer (NSCLC) patients following one or two prior systemic therapies.\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To evaluate if trametinib plus docetaxel is consistent with promise of activity measured by the response rate in G12C KRAS mutation positive NSCLC patients following one or two prior systemic therapies.\r\n\r\nII. To assess the response rate of this combination in non-G12C KRAS mutation positive NSCLC patients.\r\n\r\nIII. To assess progression-free survival within the G12C and non-G12C KRAS positive subgroups and the entire study population.\r\n\r\nIV. To evaluate the toxicity of the regimen. V. To assess overall survival within G12C positive patients, non-G12C positive patients, and the entire study population.\r\n\r\nTRANSLATIONAL MEDICINE OBJECTIVES:\r\n\r\nI. To evaluate the response rates in the presence of comutations p53 and LKB1. II. To bank specimens for future research.\r\n\r\nOUTLINE:\r\n\r\nPatients receive trametinib orally (PO) on days 1-21. Patients also receive docetaxel intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\r\n\r\nAfter completion of study treatment, patients are followed up every 6 months for 3 years.\r\n\r', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nDISEASE RELATED CRITERIA: Patients must have pathologically confirmed KRAS mutation (at codon 12, 13 and 61) positive non-small cell lung cancer (NSCLC) that is stage IV or recurrent; the specific subtype of KRAS mutation must be known; KRAS mutation testing must have been performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory; CLIA certified commercially available tests are acceptable\r\nDISEASE RELATED CRITERIA: Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to registration; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; non-measurable disease must be assessed within 42 days prior to registration; all known sites of disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST 1.1])\r\nDISEASE RELATED CRITERIA: Patients must not have known brain metastases, leptomeningeal carcinomatosis or spinal cord compression unless: (1) metastases have been locally treated (including stereotactic body radiation therapy [SBRT], whole brain radiotherapy [WBRT], and surgical resection) and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 2 days prior to registration\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must have documented progressive cancer following at least one but no more than two prior regimens of systemic therapy for lung cancer, one of which must have been platinum based combination chemotherapy; treatment with an immune therapy or targeted therapy for advanced disease will be considered a separate regimen and will count toward the prior regimens; maintenance therapy will not be counted as a separate regimen; adjuvant chemotherapy or chemotherapy administered as part of concurrent chemotherapy and radiation therapy for the treatment of lung cancer will not count as a prior regimen of systemic therapy as long as recurrence of patient\'s lung cancer occurred more than 12 months after the last day of chemotherapy\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received any chemotherapy, biologic agent, or any investigational agent within 14 days prior to registration. Patients must have recovered from any adverse events to Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 prior to registration\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Prior treatment with an anti-PD-1 or anti-PDL1 is not required\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received prior docetaxel; patients must not have received therapy with a drug known to be either a mitogen-activated protein kinase (MEK) inhibitor or a phosphatidylinositol 3 kinase (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (AKT)/mammalian target of rapamycin (mTOR) pathway inhibitor\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must have recovered from any adverse effects from prior therapy (except alopecia) to =< CTCAE grade 1 prior to registration\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients may have had prior radiation therapy as long as it has not affected greater than 25% of the bone marrow and at least one measurable lesion is outside the area of prior radiation; at least 7 days must have elapsed since last radiation treatment; patients must have recovered from any adverse events from prior radiation therapy to =< CTCAE grade 1\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have had a major surgery within 28 days prior to registration; patients must have recovered from any adverse effects of prior surgery to the satisfaction of the treating physician; biopsies and central IV access placement are not considered major surgery\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Because the composition, pharmacokinetics (PK), and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including but not limited to St. John\'s wort, kava, ephedra [ma huang], ginko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\nCLINICAL/LABORATORY CRITERIA: Patients must have Zubrod performance status of 0-2\r\nCLINICAL/LABORATORY CRITERIA: Absolute neutrophil count (ANC) >= 1500/mcL; these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Platelet count >= 100,000/mcL; these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Hemoglobin >= 9 grams/dl; these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or =< 5 x IULN for patients with known liver metastases); these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 40 mL/min; this result must have been obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Patients must be able to swallow oral medications and must not have a gastro-intestinal disorder with diarrhea as a major symptom or that may alter absorption such as malabsorption syndromes or gastric resection\r\nCLINICAL/LABORATORY CRITERIA: Patient must not have prior history of interstitial lung disease or pneumonitis\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have history of significant co-morbid illness inclusive of but not restricted to New York Heart Association class II, congestive cardiac failure, uncontrolled hypertension, history of myocardial infarction, unstable angina, coronary angioplasty, stenting or cerebrovascular accident within 6 months prior to registration or any other illness that in the assessment of the treating physician would compromise the ability of the patient to participate in this study\r\nCLINICAL/LABORATORY CRITERIA: Patients must have corrected QT (QTc) interval =< 480 msec (using the Bazett\'s formula) on electrocardiogram (ECG) performed within 42 days prior to registration; history or evidence of current clinically significant uncontrolled arrhythmias are not eligible; however, patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible; patients must not have atrial fibrillation > grade 2 on the screening ECG; patients with CTCAE grade 1-2 atrial fibrillation on their screening ECG must have a second ECG performed prior to registration and more than 30 days from the screening ECG (either before or after) with the most recent ECG showing stable or improving grade of atrial fibrillation\r\nCLINICAL/LABORATORY CRITERIA: Patients must have a left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (ILLN) by echocardiography (ECHO) or multi-gated acquisition scan (MUGA) within 42 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have untreated or unresolved retinopathy or have a history (or current evidence) of retinal vein occlusion determined by an ophthalmology exam within 42 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have an immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients, or to dimethyl sulfoxide (DMSO) or other agents used in the study\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have a known history of active hepatitis B or C infection (defined as presence of hepatitis [Hep] B surface antigen [sAg] and/or Hep B deoxyribonucleic acid [DNA] and/or Hep C ribonucleic acid [RNA]); patients must not have a known history of human immunodeficiency virus (HIV) seropositivity\r\nCLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible\r\nCLINICAL/LABORATORY CRITERIA: Patients must not be pregnant or nursing due to the risk of fetal or nursing infant harm; women/men of reproductive potential must have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation and for 4 months after the last dose of the drug; a woman is considered to be of ""reproductive potential"" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, ""effective contraception"" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures\r\nSPECIMEN SUBMISSION CRITERIA: Patients must be offered optional participation in banking of specimens for future research\r\nREGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\r\nREGULATORY CRITERIA: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'}",{'Arm - Disease - Indication': 'Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03912415,"{'Official Title': 'An International Randomized Double-blind Clinical Trial of BCD-100 Plus Platinum-based Chemotherapy With and Without Bevacizumab Versus Placebo Plus Platinum-based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer\n', 'Brief Summary': 'This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab\n', 'Condition': 'Cervical Cancer\n', 'Detailed Description': ""Subjects will be randomized in a 1:1 ratio to receive either Test Regimen or Comparator Regimen as the first-line treatment for advanced cervical cancer. Subjects will receive study therapy Q3W until progression of the disease or signs of unacceptable toxicity. In the absence of dose-limiting toxicity chemotherapy should be continued for at least 6 cycles, then, upon Investigator's decision and/or subjects' wish, the use of chemotherapy can be stopped while maintenance therapy with BCD-100/Placebo with or without bevacizumab (depending on initial therapy choice) continues until disease progression."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nSigning an IRB/EC-approved informed consent\nFemales ≥ 18 years of age on day of signing informed consent\nHistologically confirmed squamous carcinoma of the cervix\nProgressing thru or recurrent disease treated for curative intent or primary metastatic cervical cancer stage FIGO IVB\nAgreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (using archival biopsy material is only acceptable in subjects in whom obtaining a new sample is contraindicated)\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use a contraceptive method with a failure rate of < 1% per year from the moment of signing informed consent, during the treatment period and at least 6 months after administration of the last dose of study drug. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) is not acceptable method of contraception.'}",{'Arm - Disease - Indication': 'First-Line Advanced Cervical Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03912415,"{'Official Title': 'An International Randomized Double-blind Clinical Trial of BCD-100 Plus Platinum-based Chemotherapy With and Without Bevacizumab Versus Placebo Plus Platinum-based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer\n', 'Brief Summary': 'This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab\n', 'Condition': 'Cervical Cancer\n', 'Detailed Description': ""Subjects will be randomized in a 1:1 ratio to receive either Test Regimen or Comparator Regimen as the first-line treatment for advanced cervical cancer. Subjects will receive study therapy Q3W until progression of the disease or signs of unacceptable toxicity. In the absence of dose-limiting toxicity chemotherapy should be continued for at least 6 cycles, then, upon Investigator's decision and/or subjects' wish, the use of chemotherapy can be stopped while maintenance therapy with BCD-100/Placebo with or without bevacizumab (depending on initial therapy choice) continues until disease progression."", 'Inclusion Criteria': 'Inclusion Criteria:\n\nSigning an IRB/EC-approved informed consent\nFemales ≥ 18 years of age on day of signing informed consent\nHistologically confirmed squamous carcinoma of the cervix\nProgressing thru or recurrent disease treated for curative intent or primary metastatic cervical cancer stage FIGO IVB\nAgreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (using archival biopsy material is only acceptable in subjects in whom obtaining a new sample is contraindicated)\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use a contraceptive method with a failure rate of < 1% per year from the moment of signing informed consent, during the treatment period and at least 6 months after administration of the last dose of study drug. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) is not acceptable method of contraception.'}",{'Arm - Disease - Indication': 'First-Line Advanced Cervical Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04526470,"{'Official Title': 'Phase IB/II Study of Alpelisib in Combination With Paclitaxel in Patients With PIK3CA-altered Metastatic/Recurrent Gastric Cancer', 'Brief Summary': 'Alpelisib (BYL719) is a PIK3CA-specific inhibitor, which was developed by Novartis (Basel, Switzerland). Our group conducted pre-clinical study of alpelisib in eight gastric cancer cell lines: four PIK3CA wild-type (SNU638, SNU668, SNU1, and SNU16) and four PIK3CA mutant (SNU719, AGS, SNU601, and MKN). As a result, alpelisib preferentially inhibited the growth of gastric cancer cells with PIK3CA mutations. In addition, alpelisib inhibited cell growth via G1 arrest and subsequently induces apoptosis in GC cells, and this effect is more remarkable in cells harboring PIK3CA mutations. Moreover, alpelisib in combination with paclitaxel showed synergistic cytotoxic effects and significantly increased apoptosis compared with alpelisib or paclitaxel monotherapy in GC cells.\r\n\r\nThe purpose of the study is to define the maximal tolerated dose (MTD) and recommended phase II dose (RP2D) of paclitaxel and alpelisib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and AZD8186 combination therapy as a second-line therapy in patients with advanced gastric cancer with PTEN aberrations. This study is divided into Phase IB and Phase II.', 'Condition': 'Stomach Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSubject has signed the Informed Consent Form (ICF) prior to any screening procedures being performed\r\nAge ≥ 20 years old of male and female\r\nAt each phase of the trial, subjects who meet the following requirements in each phase will be enrolled.\r\n\r\nPhase IB: Subjects with a histologically-confirmed, advanced/recurrent solid tumor who have progressed on standard therapy or whose disease does not have established standard therapy.\r\nPhase II: Subjects with histologically confirmed locally advanced or metastatic gastric cancer that have progressed after treatment with first-line fluoropyrimidine-based chemotherapy (Tissue samples of gastric cancer must contain PIK3CA gene alterations (e.g. single nucleotide variants, small indels, amplifications, structural variations, etc.) identified by central or local next generation sequencing (NGS). If the subject received adjuvant chemotherapy after curative gastric resection and lymph node dissection, the adjuvant chemotherapy is considered to be the first-line palliative chemotherapy if the disease recurred during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy.\r\nPhase IB: Patient has evaluable disease as per RECIST 1.1. (Measurable lesions are not mandatory for study inclusion.) Phase II: Patient has at least one measurable lesion as per RECIST 1.1.\r\nECOG performance status 0-1\r\nPatient has adequate bone marrow and organ function as defined by the following laboratory values:\r\n\r\nAbsolute neutrophil count (ANC) ≥ 1.5 x 109/L\r\nHemoglobin ≥ 9.0 g/dL\r\nPlatelet ≥ 100 x 109/L\r\nSerum creatinine ≤ ULN (upper limit of normal) or serum creatinine clearance ≥50 mL/min (by Cockcroft-Gault formula, or 24h urine collection)\r\nTotal bilirubin: ≤ 1.5 × ULN Subjects with a bile duct obstruction will be eligible if they meet the criteria after appropriate bile drainage; Patients with Gilbert syndrome should also be included after confirming that the total bilirubin level is ≤ 1.5 x ULN in a follow-up screening test.\r\nPhase Ib: Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 3 x ULN (regardless of liver metastases)\r\nPhase II: AST and ALT ≤ 3 x ULN if liver metastases are absent, or AST and ALT ≤ 5 x ULN if liver metastases are present.\r\nThe subject is able to swallow and retain oral medication\r\nSerum β-HCG test negative within 14 days before the first administration of the study treatment (women of childbearing potential only).\r\nRequirement for contraception must be observed by the subject.'}",{'Arm - Disease - Indication': 'PIK3CA-Altered Locally Advanced Metastatic/Recurrent Gastric Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03909334,"{'Official Title': 'An Open-Label Randomized Phase II Study of Combining Osimertinib With and Without Ramucirumab in Tyrosine Kinase Inhibitor (TKI)-naïve Epidermal Growth Factor Receptor (EGFR)-Mutant Locally Advanced or Metastatic NSCLC', 'Brief Summary': 'The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.', 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nWritten informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\r\nAge ≥ 18 years at the time of consent.\r\nHistologically or cytologically confirmed non-squamous, non-small cell lung cancer.\r\nLocally advanced or metastatic disease, not amenable to curative surgery or radiotherapy.\r\nPatients must have one of the following:\r\n\r\nNSCLC which harbours EGFR Exon 19 deletion.\r\nNSCLC which harbours EGFR L858R mutation. EGFR deletion/mutation must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test (either from tissue or ctDNA from blood is allowed). If EGFR deletion/mutation testing has not been done, it should be ordered per standard of care.\r\nEastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).\r\nMeasurable disease per RECIST 1.1.\r\nPatients with brain metastases are eligible if they are asymptomatic, are treated, or are neurologically stable for at least two weeks without the use of steroids or on stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent). These criteria must be met on day of consent.\r\nAbility to take pills by mouth.\r\nPrevious treatment with cytotoxic chemotherapy or immunotherapy is allowed.\r\nPatients must have adequate hematologic, coagulation, hepatic, and renal function. All laboratory tests must be obtained less than 4 weeks from study entry. This includes:\r\n\r\nANC >/= 1,500/mm3\r\nplatelet count >/=100,000/mm3\r\nHgB ≥ 9 g/dL (may be with transfusion)\r\nCreatinine ≤ 1.5x ULN or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).\r\nThe patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in this protocol).\r\nTotal Serum Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN)\r\nSGOT, SGPT ≤ 3 X ULN if no liver metastasis present\r\nSGOT, SGPT ≤ 5 X ULN if liver metastasis present\r\nThe patient has adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) < 1.5 x upper limits of normal [ULN]. Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR ≤ 3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices.\r\nFemales of childbearing potential must have a negative serum pregnancy test within 7 days of starting of treatment. See the protocol for additional details.\r\nFemales of childbearing potential and Non-sterilized males who are sexually active with a female partner of childbearing potential must agree to use adequate contraception as outlined in the protocol.""}",{'Arm - Disease - Indication': 'Tyrosine Kinase Inhibitor - Naive EGFR Mutated Previously Treated Locally Advanced or Metastatic Non Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03909334,"{'Official Title': 'An Open-Label Randomized Phase II Study of Combining Osimertinib With and Without Ramucirumab in Tyrosine Kinase Inhibitor (TKI)-naïve Epidermal Growth Factor Receptor (EGFR)-Mutant Locally Advanced or Metastatic NSCLC', 'Brief Summary': 'The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.', 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nWritten informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\r\nAge ≥ 18 years at the time of consent.\r\nHistologically or cytologically confirmed non-squamous, non-small cell lung cancer.\r\nLocally advanced or metastatic disease, not amenable to curative surgery or radiotherapy.\r\nPatients must have one of the following:\r\n\r\nNSCLC which harbours EGFR Exon 19 deletion.\r\nNSCLC which harbours EGFR L858R mutation. EGFR deletion/mutation must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test (either from tissue or ctDNA from blood is allowed). If EGFR deletion/mutation testing has not been done, it should be ordered per standard of care.\r\nEastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).\r\nMeasurable disease per RECIST 1.1.\r\nPatients with brain metastases are eligible if they are asymptomatic, are treated, or are neurologically stable for at least two weeks without the use of steroids or on stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent). These criteria must be met on day of consent.\r\nAbility to take pills by mouth.\r\nPrevious treatment with cytotoxic chemotherapy or immunotherapy is allowed.\r\nPatients must have adequate hematologic, coagulation, hepatic, and renal function. All laboratory tests must be obtained less than 4 weeks from study entry. This includes:\r\n\r\nANC >/= 1,500/mm3\r\nplatelet count >/=100,000/mm3\r\nHgB ≥ 9 g/dL (may be with transfusion)\r\nCreatinine ≤ 1.5x ULN or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).\r\nThe patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in this protocol).\r\nTotal Serum Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN)\r\nSGOT, SGPT ≤ 3 X ULN if no liver metastasis present\r\nSGOT, SGPT ≤ 5 X ULN if liver metastasis present\r\nThe patient has adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) < 1.5 x upper limits of normal [ULN]. Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR ≤ 3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices.\r\nFemales of childbearing potential must have a negative serum pregnancy test within 7 days of starting of treatment. See the protocol for additional details.\r\nFemales of childbearing potential and Non-sterilized males who are sexually active with a female partner of childbearing potential must agree to use adequate contraception as outlined in the protocol.""}",{'Arm - Disease - Indication': 'Tyrosine Kinase Inhibitor - Naive EGFR Mutated Previously Treated Locally Advanced or Metastatic Non Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04686305,"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}",{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04686305,"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}",{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04686305,"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}",{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04686305,"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}",{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04686305,"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}",{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04686305,"{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}",{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02555189,"{'Official Title': 'Randomized Phase IB/II Study of Enzalutamide With and Without Ribociclib in Patients With Metastatic Castrate Resistant, Chemotherapy Naïve Prostate Cancer That Retains RB Expression\n', 'Brief Summary': 'This partially randomized phase IB/II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with prostate cancer that does not respond to treatment with hormones (hormone resistant), has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naïve, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer.\n', 'Condition': 'Hormone-Resistant Prostate Cancer\nMetastatic Prostate Carcinoma\nProstate Carcinoma Metastatic in the Bone\nStage IV Prostate Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES:\n\nI. To determine the maximum tolerated dose of ribociclib in combination with 160 mg of enzalutamide. (Phase Ib)\n\nII. To determine efficacy with respect to the proportion of subjects that achieve a >= 50% reduction in prostate-specific antigen (PSA) at 12 weeks. (Phase II)\n\nSECONDARY OBJECTIVES:\n\nI. PSA progression-free survival.\n\nII. Radiographic progression-free survival.\n\nIII. Safety.\n\nIV. Pharmacokinetics.\n\nTERTIARY OBJECTIVES:\n\nI. To evaluate the expression of retinoblastoma (RB) in circulating tumor cells (CTCs) and tumor tissue.\n\nII. To evaluate other mechanisms of castrate resistance (such as androgen receptor [AR]-variant [v]7) in tumor tissue and CTCs.\n\nIII. To explore resistance mechanisms of cyclin dependent kinase (CDK)4/6 inhibitors in tumor samples in patients that progress on enzalutamide and ribociclib.\n\nIV. Explore the use/correlation of circulating deoxyribonucleic acid (DNA)/exosomes in castrate-resistant prostate cancer (CRPC) patients treated with enzalutamide with and without ribociclib.\n\nV. Androgen profiles and correlation to clinical outcomes. VI. Development of model explant systems to correlate with the clinical outcome.\n\nOUTLINE: This is a phase I, dose-escalation study of ribociclib followed by a phase II study.\n\nPHASE Ib: Patients receive enzalutamide orally (PO) once daily (QD) on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPHASE II: Patients are randomized to 1 of 2 treatment arms.\n\nARM A: Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients receive enzalutamide PO QD on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months for 24 months.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nWilling and able to provide written informed consent and HIPAA authorization for the release of personal health information. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. Consent and HIPPA authorization must be obtained prior to any screening procedures.\nMales 18 years of age and above\nHistological or cytological proof of prostate cancer\nDocumented progressive mCRPC based on at least one of the following criteria:\n\nPSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.\nSoft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.\nProgression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan.\n7) Have testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy 8) ECOG performance status of 0-1 9) Patients on long term (>6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen. Patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to enrollment (no wash out period required).\n\n10) Patient has adequate bone marrow and organ function as defined by the following laboratory values:\n\nAbsolute neutrophil count ≥ 1.5 × 109/L.\nPlatelets (UNVPLT) ≥ 100 × 109/L.\nHemoglobin (HGB) ≥ 9 g/dl.\nPotassium (K), total calcium (CA)(corrected for serum albumin), magnesium, sodium (NA) and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication.\nINR ≤ 1.5.\nSerum creatinine (CREAT) ≤ 1.5 mg/dL or creatine clearance > 50 mL/min.\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN. If the patient has liver metastases, ALT and AST must still be ≤ 2.5 x ULN. Patients with liver metastases and AST/ALT above this limit will not be enrolled..\nTotal serum bilirubin ≤ 1.5 x ULN; or total bilirubin (TBILI) ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome.\n\n11) The effects of ribociclib on the developing human fetus at the recommended therapeutic dose are unknown. Men must agree to use adequate contraception prior to enrollment, for the duration of study participation and for at least 3 months thereafter.\n\n12) Must be able to take oral medication without crushing, dissolving or chewing tablets.""}",{'Arm - Disease - Indication': 'RB Expression Retaining Metastatic Castrate Resistant Chemotherapy-Naive Prostate Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02555189,"{'Official Title': 'Randomized Phase IB/II Study of Enzalutamide With and Without Ribociclib in Patients With Metastatic Castrate Resistant, Chemotherapy Naïve Prostate Cancer That Retains RB Expression\n', 'Brief Summary': 'This partially randomized phase IB/II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with prostate cancer that does not respond to treatment with hormones (hormone resistant), has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naïve, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer.\n', 'Condition': 'Hormone-Resistant Prostate Cancer\nMetastatic Prostate Carcinoma\nProstate Carcinoma Metastatic in the Bone\nStage IV Prostate Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES:\n\nI. To determine the maximum tolerated dose of ribociclib in combination with 160 mg of enzalutamide. (Phase Ib)\n\nII. To determine efficacy with respect to the proportion of subjects that achieve a >= 50% reduction in prostate-specific antigen (PSA) at 12 weeks. (Phase II)\n\nSECONDARY OBJECTIVES:\n\nI. PSA progression-free survival.\n\nII. Radiographic progression-free survival.\n\nIII. Safety.\n\nIV. Pharmacokinetics.\n\nTERTIARY OBJECTIVES:\n\nI. To evaluate the expression of retinoblastoma (RB) in circulating tumor cells (CTCs) and tumor tissue.\n\nII. To evaluate other mechanisms of castrate resistance (such as androgen receptor [AR]-variant [v]7) in tumor tissue and CTCs.\n\nIII. To explore resistance mechanisms of cyclin dependent kinase (CDK)4/6 inhibitors in tumor samples in patients that progress on enzalutamide and ribociclib.\n\nIV. Explore the use/correlation of circulating deoxyribonucleic acid (DNA)/exosomes in castrate-resistant prostate cancer (CRPC) patients treated with enzalutamide with and without ribociclib.\n\nV. Androgen profiles and correlation to clinical outcomes. VI. Development of model explant systems to correlate with the clinical outcome.\n\nOUTLINE: This is a phase I, dose-escalation study of ribociclib followed by a phase II study.\n\nPHASE Ib: Patients receive enzalutamide orally (PO) once daily (QD) on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPHASE II: Patients are randomized to 1 of 2 treatment arms.\n\nARM A: Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients receive enzalutamide PO QD on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months for 24 months.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nWilling and able to provide written informed consent and HIPAA authorization for the release of personal health information. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. Consent and HIPPA authorization must be obtained prior to any screening procedures.\nMales 18 years of age and above\nHistological or cytological proof of prostate cancer\nDocumented progressive mCRPC based on at least one of the following criteria:\n\nPSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.\nSoft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.\nProgression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan.\n7) Have testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy 8) ECOG performance status of 0-1 9) Patients on long term (>6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen. Patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to enrollment (no wash out period required).\n\n10) Patient has adequate bone marrow and organ function as defined by the following laboratory values:\n\nAbsolute neutrophil count ≥ 1.5 × 109/L.\nPlatelets (UNVPLT) ≥ 100 × 109/L.\nHemoglobin (HGB) ≥ 9 g/dl.\nPotassium (K), total calcium (CA)(corrected for serum albumin), magnesium, sodium (NA) and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication.\nINR ≤ 1.5.\nSerum creatinine (CREAT) ≤ 1.5 mg/dL or creatine clearance > 50 mL/min.\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN. If the patient has liver metastases, ALT and AST must still be ≤ 2.5 x ULN. Patients with liver metastases and AST/ALT above this limit will not be enrolled..\nTotal serum bilirubin ≤ 1.5 x ULN; or total bilirubin (TBILI) ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome.\n\n11) The effects of ribociclib on the developing human fetus at the recommended therapeutic dose are unknown. Men must agree to use adequate contraception prior to enrollment, for the duration of study participation and for at least 3 months thereafter.\n\n12) Must be able to take oral medication without crushing, dissolving or chewing tablets.""}",{'Arm - Disease - Indication': 'RB Expression Retaining Metastatic Castrate Resistant Chemotherapy-Naive Prostate Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03647969,"{'Official Title': 'Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm.\r\n\r\nPatients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg ""Flatdose"" i.v. d1 every 2 weeks) and Ipilimumab (1mg/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg ""Flatdose"" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks).\r\n\r\nTreatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment.\r\n\r\nThe primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1).\r\n\r\nSecondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis.\r\n\r\n257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAll subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma.\r\nSubjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour.\r\nSubject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.\r\nPrior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization/enrolment.\r\nPalliative radiotherapy is allowed and must be completed 2 weeks prior to randomization/enrolment.\r\nSubjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D).\r\nECOG performance status score of 0 or 1 (Appendix B).\r\nLife expectancy > 12 weeks\r\nScreening laboratory values must meet the following criteria (using NCI CTCAE v.4.03):\r\n\r\nWBC ≥ 2000/uL\r\nNeutrophils ≥ 1500/µL\r\nPlatelets ≥ 100x10^3/µL\r\nHemoglobin ≥ 9.0 g/dL\r\nSerum creatinine ≤ 1.5 x ULN\r\nAST ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nALT ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nTotal Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN)\r\nMales and Females* ≥ 18 years of age\r\n\r\n*There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently.\r\n\r\nSubjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\r\nSubjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\r\nWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding.\r\nWOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug.\r\nMales who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.'}",{'Arm - Disease - Indication': 'Previously Untreated HER2-negative Advanced or Metastatic Esophagogastric Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03647969,"{'Official Title': 'Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm.\r\n\r\nPatients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg ""Flatdose"" i.v. d1 every 2 weeks) and Ipilimumab (1mg/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg ""Flatdose"" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks).\r\n\r\nTreatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment.\r\n\r\nThe primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1).\r\n\r\nSecondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis.\r\n\r\n257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAll subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma.\r\nSubjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour.\r\nSubject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.\r\nPrior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization/enrolment.\r\nPalliative radiotherapy is allowed and must be completed 2 weeks prior to randomization/enrolment.\r\nSubjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D).\r\nECOG performance status score of 0 or 1 (Appendix B).\r\nLife expectancy > 12 weeks\r\nScreening laboratory values must meet the following criteria (using NCI CTCAE v.4.03):\r\n\r\nWBC ≥ 2000/uL\r\nNeutrophils ≥ 1500/µL\r\nPlatelets ≥ 100x10^3/µL\r\nHemoglobin ≥ 9.0 g/dL\r\nSerum creatinine ≤ 1.5 x ULN\r\nAST ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nALT ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nTotal Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN)\r\nMales and Females* ≥ 18 years of age\r\n\r\n*There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently.\r\n\r\nSubjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\r\nSubjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\r\nWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding.\r\nWOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug.\r\nMales who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.'}",{'Arm - Disease - Indication': 'Previously Untreated HER2-negative Advanced or Metastatic Esophagogastric Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03647969,"{'Official Title': 'Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm.\r\n\r\nPatients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg ""Flatdose"" i.v. d1 every 2 weeks) and Ipilimumab (1mg/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg ""Flatdose"" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks).\r\n\r\nTreatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment.\r\n\r\nThe primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1).\r\n\r\nSecondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis.\r\n\r\n257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAll subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma.\r\nSubjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour.\r\nSubject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.\r\nPrior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization/enrolment.\r\nPalliative radiotherapy is allowed and must be completed 2 weeks prior to randomization/enrolment.\r\nSubjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D).\r\nECOG performance status score of 0 or 1 (Appendix B).\r\nLife expectancy > 12 weeks\r\nScreening laboratory values must meet the following criteria (using NCI CTCAE v.4.03):\r\n\r\nWBC ≥ 2000/uL\r\nNeutrophils ≥ 1500/µL\r\nPlatelets ≥ 100x10^3/µL\r\nHemoglobin ≥ 9.0 g/dL\r\nSerum creatinine ≤ 1.5 x ULN\r\nAST ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nALT ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nTotal Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN)\r\nMales and Females* ≥ 18 years of age\r\n\r\n*There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently.\r\n\r\nSubjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\r\nSubjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\r\nWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding.\r\nWOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug.\r\nMales who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.'}",{'Arm - Disease - Indication': 'Previously Untreated HER2-negative Advanced or Metastatic Esophagogastric Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03647969,"{'Official Title': 'Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm.\r\n\r\nPatients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg ""Flatdose"" i.v. d1 every 2 weeks) and Ipilimumab (1mg/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg ""Flatdose"" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg ""Flatdose"" i.v. d1 every 2 weeks).\r\n\r\nTreatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment.\r\n\r\nThe primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1).\r\n\r\nSecondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis.\r\n\r\n257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAll subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma.\r\nSubjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour.\r\nSubject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.\r\nPrior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization/enrolment.\r\nPalliative radiotherapy is allowed and must be completed 2 weeks prior to randomization/enrolment.\r\nSubjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D).\r\nECOG performance status score of 0 or 1 (Appendix B).\r\nLife expectancy > 12 weeks\r\nScreening laboratory values must meet the following criteria (using NCI CTCAE v.4.03):\r\n\r\nWBC ≥ 2000/uL\r\nNeutrophils ≥ 1500/µL\r\nPlatelets ≥ 100x10^3/µL\r\nHemoglobin ≥ 9.0 g/dL\r\nSerum creatinine ≤ 1.5 x ULN\r\nAST ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nALT ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nTotal Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN)\r\nMales and Females* ≥ 18 years of age\r\n\r\n*There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently.\r\n\r\nSubjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\r\nSubjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\r\nWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding.\r\nWOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug.\r\nMales who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.'}",{'Arm - Disease - Indication': 'Previously Untreated HER2-negative Advanced or Metastatic Esophagogastric Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02824458,"{'Official Title': 'A Multicenter, Randomized,Double-Blind Study of Gefitinib in Combination With Apatinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-squamous Non-Small-Cell Lung Cancer', 'Brief Summary': 'The main purpose of this study is to evaluate the safety and efficacy of Apatinib in combination with Gefitinib as compared to placebo in combination with Gefitinib in participants with stage ⅢB-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).', 'Condition': 'Non-Small-Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n≥ 18 and ≤ 70 years of age\r\nEastern Cooperative Oncology Group(ECOG)performance scale 0 - 1.\r\nLife expectancy of more than 3 weeks.\r\nHistologically or cytologic confirmed，locally advanced and/or metastatic non-squamous NSCLC of stage IIIB (unsuitable for radiotherapy) or IV or recurrent NSCLC; At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy or cryotherapy.\r\nDocumented evidence of tumor harboring an activating EGFR mutation (Example 19 del and L858R) .\r\nNone previous chemotherapy or targeted therapy. NOTE: neoadjuvant and/or adjuvant therapy is allowed which is completed before 6 months.\r\nPrior radiation therapy is allowed if: 25% or less of total bone marrow had been irradiated,pelvis and chest had not been irradiated; at least 4 weeks have elapsed from the completion of radiation treatment, and the acute toxicity from radiation treatment had been recover; irradiated lesion is not including measurable lesions unless documented progress after radiation.\r\nAdequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 100×109/L, Hemoglobin(HB) ≥ 100 g/L, total bilirubin within 1.5×the upper limit of normal(ULN), and serum transaminase≤2.5×the Upper Limit Of Normal(ULN), serum creatine ≤ 1 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥ 50ml/min,\r\nFor women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.\r\nSigned and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.'}","{'Arm - Disease - Indication': 'Previously Untreated EGFR Mutated Stage IIIB-Stage IV Advanced Stage ⅢB-IV , Advanced, Locally Advanced, Metastatic Non-squamous Non-small-cell Lung Cancer '}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02824458,"{'Official Title': 'A Multicenter, Randomized,Double-Blind Study of Gefitinib in Combination With Apatinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-squamous Non-Small-Cell Lung Cancer', 'Brief Summary': 'The main purpose of this study is to evaluate the safety and efficacy of Apatinib in combination with Gefitinib as compared to placebo in combination with Gefitinib in participants with stage ⅢB-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).', 'Condition': 'Non-Small-Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n≥ 18 and ≤ 70 years of age\r\nEastern Cooperative Oncology Group(ECOG)performance scale 0 - 1.\r\nLife expectancy of more than 3 weeks.\r\nHistologically or cytologic confirmed，locally advanced and/or metastatic non-squamous NSCLC of stage IIIB (unsuitable for radiotherapy) or IV or recurrent NSCLC; At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy or cryotherapy.\r\nDocumented evidence of tumor harboring an activating EGFR mutation (Example 19 del and L858R) .\r\nNone previous chemotherapy or targeted therapy. NOTE: neoadjuvant and/or adjuvant therapy is allowed which is completed before 6 months.\r\nPrior radiation therapy is allowed if: 25% or less of total bone marrow had been irradiated,pelvis and chest had not been irradiated; at least 4 weeks have elapsed from the completion of radiation treatment, and the acute toxicity from radiation treatment had been recover; irradiated lesion is not including measurable lesions unless documented progress after radiation.\r\nAdequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 100×109/L, Hemoglobin(HB) ≥ 100 g/L, total bilirubin within 1.5×the upper limit of normal(ULN), and serum transaminase≤2.5×the Upper Limit Of Normal(ULN), serum creatine ≤ 1 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥ 50ml/min,\r\nFor women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.\r\nSigned and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.'}","{'Arm - Disease - Indication': 'Previously Untreated EGFR Mutated Stage IIIB-Stage IV Advanced Stage ⅢB-IV , Advanced, Locally Advanced, Metastatic Non-squamous Non-small-cell Lung Cancer '}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05214222,"{'Official Title': 'Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With Advanced Esophageal Squamous Cell Carcinoma (Answer): A Randomized Two-arm Clinical Study', 'Brief Summary': 'Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study', 'Condition': 'Essential Tremor', 'Detailed Description': 'This is a open-label, phase II study of Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy in subjects With resectable advanced esophageal squamous cell carcinoma. The patients will be divided into two groups. In group A, Penpulimab plus chemotherapy with Anlotinib will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Anlotinib and Penpulimab will be used every 3 weeks until disease progression or intolerance; In group B, Penpulimab plus chemotherapy will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Penpulimab will be used every 3 weeks until disease progression or intolerance;', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients with advanced metastatic esophageal squamous cell carcinoma who cannot receive radical treatment (excluding mixed adenosquamous carcinoma);\r\nThose who have not received systemic treatment in the past, or (new) adjuvant treatment/radical surgery/radical radiotherapy and chemotherapy have relapsed for more than 6 months; Note: Including patients with advanced or recurring non-target lesions who have progressed again after radiotherapy alone. For local lesions (non-target lesions), the time from the end of palliative treatment to the enrollment time> 2 weeks;\r\nAccording to the RECIST 1.1 version of the curative effect evaluation standard for solid tumors, there is at least one measurable lesion; the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area, if it is confirmed that it has progressed, and meets RECIST1.1 Standard, target lesions can also be selected);\r\nPatients between 18 and 75 years old;\r\nECOGPS score: 0~1 points; the expected survival period is more than 3 months;\r\nTumor specimens can be provided to determine gene detection and PD-L1 expression, at least 15 white sheets (assessed by the company); provide two oral swabs; within 7 days before the medication, the first, third, and sixth at the end of the cycle, one tube of 6ml EDTA anticoagulant blood will be provided.\r\nIt has sufficient organ and bone marrow function, that is, it meets the following standards:\r\n(1) The standard of routine blood examination must meet: Hemoglobin content (HB) ≥90g/L (no blood transfusion within 28 days); Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count (PLT) ≥100×109/L. (2) The biochemical inspection shall meet the following standards: Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); ALT and AST≤2.5´ULN; if there is liver metastasis, ALT and AST≤5´ULN; Cr≤1.5´ULN or creatinine clearance (CCr)≥60ml/min; (Cockcroft-Gault formula) (3) The coagulation function is adequate, which is defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8) Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the treatment, and they must be non-lactating patients. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:\r\n\r\nPost-menopausal is defined as amenorrhea at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped;\r\nFor women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference value range, also Can be considered post-menopausal;\r\nHave received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral tubal ligation.\r\nFor men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 9) The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.'}",{'Arm - Disease - Indication': 'First-Line Resectable Advanced Metastatic Esophageal Squamous Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05214222,"{'Official Title': 'Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With Advanced Esophageal Squamous Cell Carcinoma (Answer): A Randomized Two-arm Clinical Study', 'Brief Summary': 'Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study', 'Condition': 'Essential Tremor', 'Detailed Description': 'This is a open-label, phase II study of Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy in subjects With resectable advanced esophageal squamous cell carcinoma. The patients will be divided into two groups. In group A, Penpulimab plus chemotherapy with Anlotinib will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Anlotinib and Penpulimab will be used every 3 weeks until disease progression or intolerance; In group B, Penpulimab plus chemotherapy will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Penpulimab will be used every 3 weeks until disease progression or intolerance;', 'Inclusion Criteria': 'Inclusion Criteria:\n\nPatients with advanced metastatic esophageal squamous cell carcinoma who cannot receive radical treatment (excluding mixed adenosquamous carcinoma);\nThose who have not received systemic treatment in the past, or (new) adjuvant treatment/radical surgery/radical radiotherapy and chemotherapy have relapsed for more than 6 months; Note: Including patients with advanced or recurring non-target lesions who have progressed again after radiotherapy alone. For local lesions (non-target lesions), the time from the end of palliative treatment to the enrollment time> 2 weeks;\nAccording to the RECIST 1.1 version of the curative effect evaluation standard for solid tumors, there is at least one measurable lesion; the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area, if it is confirmed that it has progressed, and meets RECIST1.1 Standard, target lesions can also be selected);\nPatients between 18 and 75 years old;\nECOGPS score: 0~1 points; the expected survival period is more than 3 months;\nTumor specimens can be provided to determine gene detection and PD-L1 expression, at least 15 white sheets (assessed by the company); provide two oral swabs; within 7 days before the medication, the first, third, and sixth at the end of the cycle, one tube of 6ml EDTA anticoagulant blood will be provided.\nIt has sufficient organ and bone marrow function, that is, it meets the following standards:\n(1) The standard of routine blood examination must meet: Hemoglobin content (HB) ≥90g/L (no blood transfusion within 28 days); Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count (PLT) ≥100×109/L. (2) The biochemical inspection shall meet the following standards: Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); ALT and AST≤2.5´ULN; if there is liver metastasis, ALT and AST≤5´ULN; Cr≤1.5´ULN or creatinine clearance (CCr)≥60ml/min; (Cockcroft-Gault formula) (3) The coagulation function is adequate, which is defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8) Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the treatment, and they must be non-lactating patients. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:\n\nPost-menopausal is defined as amenorrhea at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped;\nFor women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference value range, also Can be considered post-menopausal;\nHave received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral tubal ligation.\nFor men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 9) The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.'}",{'Arm - Disease - Indication': 'First-Line Resectable Advanced Metastatic Esophageal Squamous Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05842317,"{'Official Title': 'A Randomized, Controlled, Single-center Clinical Study of Lenvatinib in Combination With Tislelizumab With or Without TACE in First-line Treatment of Advanced Hepatocellular Carcinoma.', 'Brief Summary': 'To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety', 'Condition': 'Hepatocellular Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nParticipants must meet all of the following criteria to be included:\r\nParticipants must voluntarily agree to participate in the study and provide written informed consent, be compliant, and agree to follow-up.\r\nParticipants must be between 18 and 80 years old, regardless of gender, at the time of signing the informed consent form.\r\nParticipants must be diagnosed with hepatocellular carcinoma by imaging (according to AASLD criteria or the 2022 National Health Commission Guidelines for the Diagnosis and Treatment of Liver Cancer) or histological or cytological examination.\r\nPatients with advanced liver cancer: patients who are in BCLC stage C or B and are eligible for TACE treatment.\r\nParticipants must not have received systemic treatment.\r\nThere must be at least one measurable lesion (according to RECIST 1.1 criteria, the measurable lesion must have a spiral CT scan long diameter ≥10 mm or an enlarged lymph node short diameter ≥15 mm).\r\nECOG performance status must be 0-1 point within 1 week before enrollment.\r\nChild-Pugh liver function grade: Class A (5-6 points).\r\nExpected survival time ≥3 months.\r\nActive hepatitis B or C patients must receive relevant antiviral treatment, with HBV-DNA <2500 IU/mL (<105 copies/mL) and have received antiviral treatment for at least 14 days before participating in the study. HCV RNA-positive patients must be treated according to local standard treatment guidelines and have liver function increased no more than Grade 1 in CTCAE during treatment.\r\nHematological and organ function must be adequate, based on laboratory test results obtained within 14 days before starting the study treatment, unless otherwise specified:\r\nComplete blood count: (not transfused, not treated with G-CSF or drugs for correction) white blood cell count ≥ 3.0 x 109/L, Hb ≥ 90 g/L, neutrophil count ≥ 1.5 × 109/L, and platelet count ≥ 60 × 109/L.\r\n\r\nBiochemical tests: (not given albumin in the last 14 days)\r\nAppropriate liver function: ALB ≥ 29 g/L, ALP, ALT, and AST <5 × ULN, TBIL ≤ 3 × ULN, and PT prolongation time no more than 6s of ULN\r\nAppropriate renal function: Creatinine ≤ 1.5 × ULN, or creatinine clearance (CCr) >50 mL/min (using the Cockcroft-Gault formula):\r\nFemale: CrCl = ((140 - age) × body weight (kg) × 0.85) / 72 × serum creatinine (mg/dL) Male: CrCl = ((140 - age) × body weight (kg) × 1.00) / 72 × serum creatinine (mg/dL)\r\n\r\n• Women of childbearing potential: must agree to abstain from sexual activity or use a contraceptive method with a failure rate of less than 1% for at least 6 months during the treatment period and after the last dose.\r\n\r\nIf a female patient has menstruated and has not yet reached postmenopausal status (no menstrual periods for ≥12 months continuously, and no other causes for menopause except surgical sterilization), and has not undergone sterilization surgery (removal of the ovaries and/or uterus), she is considered to be of childbearing potential.'}",{'Arm - Disease - Indication': 'First-line Advanced Hepatocellular Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05842317,"{'Official Title': 'A Randomized, Controlled, Single-center Clinical Study of Lenvatinib in Combination With Tislelizumab With or Without TACE in First-line Treatment of Advanced Hepatocellular Carcinoma.', 'Brief Summary': 'To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety', 'Condition': 'Hepatocellular Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be included:\nParticipants must voluntarily agree to participate in the study and provide written informed consent, be compliant, and agree to follow-up.\nParticipants must be between 18 and 80 years old, regardless of gender, at the time of signing the informed consent form.\nParticipants must be diagnosed with hepatocellular carcinoma by imaging (according to AASLD criteria or the 2022 National Health Commission Guidelines for the Diagnosis and Treatment of Liver Cancer) or histological or cytological examination.\nPatients with advanced liver cancer: patients who are in BCLC stage C or B and are eligible for TACE treatment.\nParticipants must not have received systemic treatment.\nThere must be at least one measurable lesion (according to RECIST 1.1 criteria, the measurable lesion must have a spiral CT scan long diameter ≥10 mm or an enlarged lymph node short diameter ≥15 mm).\nECOG performance status must be 0-1 point within 1 week before enrollment.\nChild-Pugh liver function grade: Class A (5-6 points).\nExpected survival time ≥3 months.\nActive hepatitis B or C patients must receive relevant antiviral treatment, with HBV-DNA <2500 IU/mL (<105 copies/mL) and have received antiviral treatment for at least 14 days before participating in the study. HCV RNA-positive patients must be treated according to local standard treatment guidelines and have liver function increased no more than Grade 1 in CTCAE during treatment.\nHematological and organ function must be adequate, based on laboratory test results obtained within 14 days before starting the study treatment, unless otherwise specified:\nComplete blood count: (not transfused, not treated with G-CSF or drugs for correction) white blood cell count ≥ 3.0 x 109/L, Hb ≥ 90 g/L, neutrophil count ≥ 1.5 × 109/L, and platelet count ≥ 60 × 109/L.\n\nBiochemical tests: (not given albumin in the last 14 days)\nAppropriate liver function: ALB ≥ 29 g/L, ALP, ALT, and AST <5 × ULN, TBIL ≤ 3 × ULN, and PT prolongation time no more than 6s of ULN\nAppropriate renal function: Creatinine ≤ 1.5 × ULN, or creatinine clearance (CCr) >50 mL/min (using the Cockcroft-Gault formula):\nFemale: CrCl = ((140 - age) × body weight (kg) × 0.85) / 72 × serum creatinine (mg/dL) Male: CrCl = ((140 - age) × body weight (kg) × 1.00) / 72 × serum creatinine (mg/dL)\n\n• Women of childbearing potential: must agree to abstain from sexual activity or use a contraceptive method with a failure rate of less than 1% for at least 6 months during the treatment period and after the last dose.\n\nIf a female patient has menstruated and has not yet reached postmenopausal status (no menstrual periods for ≥12 months continuously, and no other causes for menopause except surgical sterilization), and has not undergone sterilization surgery (removal of the ovaries and/or uterus), she is considered to be of childbearing potential.'}",{'Arm - Disease - Indication': 'First-line Advanced Hepatocellular Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05163249,"{'Official Title': 'A Prospective, Pilot Study of First-line Osimertinib With or Without Savolitinib in de Novo MET Positive, EGFR-mutant NSCLCs (FLOWERS)\n', 'Brief Summary': 'This is a prospective, pilot, two-arm, randomized, multicenter study exploring the efficacy and safety of osimertinib with or without savolitinib as first-line therapy in patients with de novo MET positive, EGFR-mutant advanced NSCLC.\n', 'Condition': 'Carcinoma, Non-Small-Cell Lung', 'Detailed Description': 'Approximately 44 eligible patients will be enrolled to randomly assigned to study interventions so that approximately 40 evaluable participants complete the study, based on an assumption of 10% of participants not completing the study.\n\nAll eligible patients will be randomized in a 1:1 ratio to receive treatment with osimertinib (80 mg daily) or osimertinib (80 mg daily) in combination with savolitinib (300 mg BID) in this study. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.\n\nPatients who progress on first-line treatment of osimertinib monotherapy will have the opportunity to receive second-line treatment of osimertinib plus savolitinib after confirmation of MET status at disease progression.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nInformed consent\n\nCapable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\nProvision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.\n\nAge\n\nParticipant must be ≥18 years at the time of signing the ICF. All genders are permitted.\n\nType of Participant and Disease Characteristics\n\nHistologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity.\nHas not received any systemic treatment of advanced NSCLC.\n\nPrior adjuvant/neo-adjuvant therapy completed > 6 months before screening is allowed.\nMET amplification/high expression as determined by FISH, IHC or NGS testing on tumor tissue collected before any systemic treatment in first line.\n\nMET high expression by IHC, 3+ in ≥75% of tumor cells\nincreased MET gene copy number by FISH, MET gene copy ≥5 or MET / CEP7 ratio ≥2; or by tissue NGS, ≥20% tumour cells, ≥200x sequencing depth of coverage and CN ≥5.\nLocal IHC, FISH and pre-existing local NGS results are acceptable, central FISH and central NGS confirmation is highly suggested if tissue sample available.\nWHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing and a minimum life expectancy of 12 weeks.\nAt least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\nAdequate haematological function defined as:\n\nHaemoglobin≥8.5 g/dL (no transfusion in the past 2 weeks).\nAbsolute neutrophil count ≥1.5×109/L.\nPlatelet count ≥100,000/μL (no transfusion in the past 10 days)\nAdequate liver function defined as:\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN) with total bilirubin (TBL) ≤ ULN\nOR TBL >ULN to ≤1.5x ULN with ALT and AST ≤ ULN\nAdequate renal function defined as a creatinine <1.5 times the institutional ULN OR a glomerular filtration rate ≥50 mL/min, as assessed using the standard methodology at the investigating centre (eg, Cockcroft-Gault, Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration formulae, ethylenediaminetetraacetic acid clearance or 24-hour urine collection). Confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.\nAdequate coagulation parameters, defined as:\n\nInternational Normalisation Ratio (INR) <1.5 x ULN and activated partial thromboplastin time <1.5 x ULN unless patients are receiving therapeutic anti coagulation which affects these parameters.\nPatients with known tumor thrombus or deep vein thrombosis are eligible if clinically stable on low molecular weight heparin (LMWH) for ≥2 weeks.\nAbility to swallow and retain oral medications.\nWillingness and ability to comply with study and follow-up procedures.\n\nReproduction\n\nFemales must be using highly effective contraceptive measures (see Section 5.3.2), and have a negative pregnancy test (serum) for women of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:\n\nPost-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\nWomen under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.\nWomen with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\nFurther information is available in Appendix F (Contraception Requirements).\nMale patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.'}",{'Arm - Disease - Indication': 'De Novo MET Positive EGFR Mutant Advanced Locally Advanced or Metastatic Non Small Cell Lung Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05163249,"{'Official Title': 'A Prospective, Pilot Study of First-line Osimertinib With or Without Savolitinib in de Novo MET Positive, EGFR-mutant NSCLCs (FLOWERS)\n', 'Brief Summary': 'This is a prospective, pilot, two-arm, randomized, multicenter study exploring the efficacy and safety of osimertinib with or without savolitinib as first-line therapy in patients with de novo MET positive, EGFR-mutant advanced NSCLC.\n', 'Condition': 'Carcinoma, Non-Small-Cell Lung', 'Detailed Description': 'Approximately 44 eligible patients will be enrolled to randomly assigned to study interventions so that approximately 40 evaluable participants complete the study, based on an assumption of 10% of participants not completing the study.\n\nAll eligible patients will be randomized in a 1:1 ratio to receive treatment with osimertinib (80 mg daily) or osimertinib (80 mg daily) in combination with savolitinib (300 mg BID) in this study. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.\n\nPatients who progress on first-line treatment of osimertinib monotherapy will have the opportunity to receive second-line treatment of osimertinib plus savolitinib after confirmation of MET status at disease progression.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nInformed consent\n\nCapable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\nProvision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.\n\nAge\n\nParticipant must be ≥18 years at the time of signing the ICF. All genders are permitted.\n\nType of Participant and Disease Characteristics\n\nHistologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity.\nHas not received any systemic treatment of advanced NSCLC.\n\nPrior adjuvant/neo-adjuvant therapy completed > 6 months before screening is allowed.\nMET amplification/high expression as determined by FISH, IHC or NGS testing on tumor tissue collected before any systemic treatment in first line.\n\nMET high expression by IHC, 3+ in ≥75% of tumor cells\nincreased MET gene copy number by FISH, MET gene copy ≥5 or MET / CEP7 ratio ≥2; or by tissue NGS, ≥20% tumour cells, ≥200x sequencing depth of coverage and CN ≥5.\nLocal IHC, FISH and pre-existing local NGS results are acceptable, central FISH and central NGS confirmation is highly suggested if tissue sample available.\nWHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing and a minimum life expectancy of 12 weeks.\nAt least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\nAdequate haematological function defined as:\n\nHaemoglobin≥8.5 g/dL (no transfusion in the past 2 weeks).\nAbsolute neutrophil count ≥1.5×109/L.\nPlatelet count ≥100,000/μL (no transfusion in the past 10 days)\nAdequate liver function defined as:\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN) with total bilirubin (TBL) ≤ ULN\nOR TBL >ULN to ≤1.5x ULN with ALT and AST ≤ ULN\nAdequate renal function defined as a creatinine <1.5 times the institutional ULN OR a glomerular filtration rate ≥50 mL/min, as assessed using the standard methodology at the investigating centre (eg, Cockcroft-Gault, Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration formulae, ethylenediaminetetraacetic acid clearance or 24-hour urine collection). Confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.\nAdequate coagulation parameters, defined as:\n\nInternational Normalisation Ratio (INR) <1.5 x ULN and activated partial thromboplastin time <1.5 x ULN unless patients are receiving therapeutic anti coagulation which affects these parameters.\nPatients with known tumor thrombus or deep vein thrombosis are eligible if clinically stable on low molecular weight heparin (LMWH) for ≥2 weeks.\nAbility to swallow and retain oral medications.\nWillingness and ability to comply with study and follow-up procedures.\n\nReproduction\n\nFemales must be using highly effective contraceptive measures (see Section 5.3.2), and have a negative pregnancy test (serum) for women of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:\n\nPost-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\nWomen under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.\nWomen with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\nFurther information is available in Appendix F (Contraception Requirements).\nMale patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.'}",{'Arm - Disease - Indication': 'De Novo MET Positive EGFR Mutant Advanced Locally Advanced or Metastatic Non Small Cell Lung Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03675737,"{'Official Title': 'A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).', 'Condition': 'Stomach Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status\nHas human epidermal growth factor receptor 2 (HER2) negative cancer\nMale Participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy refrain from donating sperm and be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period\nFemale Participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period\nHas measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated\nHas provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis\nHas provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention\nHas adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment'}",{'Arm - Disease - Indication': 'Adult First-Line HER2 Negative Previously Untreated Locally Advanced Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03675737,"{'Official Title': 'A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants.\r\n\r\nThe primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).', 'Condition': 'Stomach Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status\nHas human epidermal growth factor receptor 2 (HER2) negative cancer\nMale Participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy refrain from donating sperm and be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period\nFemale Participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period\nHas measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated\nHas provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis\nHas provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention\nHas adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment'}",{'Arm - Disease - Indication': 'Adult First-Line HER2 Negative Previously Untreated Locally Advanced Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05001971,"{'Official Title': 'Anlotinib Plus Penpulimab for the Treatment of Sensitive Relapsed Small-Cell Lung Cancer: a Multicenter, Single-arm, Explorative Trial', 'Brief Summary': ""Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase II ALTER1202 trial, patients who failed at least two kinds of systemic chemotherapy regimens (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 4.1 months and 7.3 months, the placebo group PFS and OS were 0.7 months and 4.9 months. Therefore, the combination of Anlotinib and Penpulimab (a new PD-1 inhibitor) is attempted for the treatment of sensitive relapsed small-cell lung cancer patients who were failure in the first-line treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS"", 'Condition': 'Small Cell Lung Cancer', 'Detailed Description': 'This is a multicenter, single-arm, explorative clinical trial conducted in China to investigate the effectiveness and safety of Anlotinib Plus Penpulimab in patients of sensitive relapsed small-cell lung cancer.\r\n\r\nEligible patients will receive Anlotinib plus Penpulimab:\r\n\r\nAnlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. Penpulimab: 200mg by intravenous drip on day 1 of a 21-day cycle.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nsigned and dated informed consent\r\nSmall cell lung cancer pathologically confirmed, with measurable nidus (RECIST 1.1)\r\nhave failed for first-line chemotherapy\r\nhave a time interval ≥ 3 months between relapse and the end of the last systemic chemotherapy\r\nECOG PS: 0-1, Expected Survival Time: Over 3 months\r\nmain organs function is normal\r\nthe woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 8 weeks after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.'}",{'Arm - Disease - Indication': 'Sensitive Relapsed Small-Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03064867,"{'Official Title': 'Phase I/II Trial of Venetoclax in Combination With R-ICE (V+RICE) Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma', 'Brief Summary': 'The purpose of this study is to determine the correct dose and safety of adding a new cancer drug, venetoclax, to a standard combination of chemotherapy drugs as a second treatment for relapsed/refractory DLBCL. In this study, venetoclax will be added to RICE (rituximab, ifosfamide, carboplatin, etoposide), a common set to cancer drugs used as a second line treatment for relapsed/refractory DLBCL.\r\n\r\nVenetoclax, is a new targeted anti-cancer drug, which works by mimicking a particular protein produced by the tumor and interrupting its normal processes, ultimately causing the tumor cells to die. Adding venetoclax to the standard RICE regimen is believed to increase the chance of getting cancer into remission.\r\n\r\nVenetoclax is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of relapsed/refractory DLBCL. Venetoclax has been FDA approved for use in patients with chronic lymphocytic leukemia (CLL).', 'Condition': 'Diffuse Large B-cell-lymphoma', 'Detailed Description': 'Primary Objective:\r\n\r\nEstablishment of safety of V+RICE in order to identify the recommended Phase II dose (RPD2)\r\n\r\nSecondary Objectives:\r\n\r\nDetermine the overall response rate (ORR) of V+RICE relative to historical controls of RICE alone in r/r DLBCL.\r\nDetermine the proportion of patients who proceed to autologous stem cell transplantation after V+RICE relative to historical controls.\r\nDescribe the progression-free survival (PFS) and overall survival (OS) for patients treated with V + RICE who do and do not proceed to auto-Stem Cell Transplant, relative to historical controls.\r\nMeasure total number of peripheral blood stem cells collected in patients treated with V + RICE who proceed to stem cell mobilization/harvesting, compared to historical controls.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nHistological confirmation of relapsed/refractory diffuse large B-cell lymphoma after prior rituximab and anthracycline-containing systemic treatment regimen such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), R-EPOCH (rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride), R-HyperCVAD (rituximab, cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone) etc. A biopsy immediately before enrollment is not required.\r\nSubjects must have received no more than 2 prior systemic therapies for lymphoma. Prior therapy with systemic rituximab monotherapy or conventional chemotherapy (i.e. bendamustine, CVP (Cyclophosphamide, Vincristine Sulfate, Prednisone) or other) ± rituximab for indolent non-Hodgkin's lymphoma (NHL) ± maintenance/extended-use rituximab will count as 1 line of systemic therapy.\r\nEastern Cooperative Oncology Group (ECOG) Performance status ≤ 2\r\nSubjects must have normal organ and marrow function as defined below:\r\n\r\nHemoglobin ≥ 8.0 g/dl\r\nAbsolute neutrophil count ≥ 1,000/mcL\r\nPlatelet count ≥ 75,000/mcL\r\nTotal bilirubin ≤ 1.5 X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert's, for whom the maximum will be 2.5 ULN.\r\nAspartate transaminase (AST) (SGOT) ≤ 2.5 X institutional ULN\r\nAlanine transaminase (ALT) (SGPT) ≤ 2.5 X institutional ULN\r\nInternational normalized ratio (INR) ≤ 1.5 ×ULN\r\nPatients must have a calculated serum creatinine clearance > 50 mL/min using Cockcroft-Gault calculation or based on 24-hour urine collection performed within 7 days prior to treatment.\r\nSpecific guidelines will be followed regarding inclusion of relapsed/refractory DLBCL based on Hepatitis B serological testing as follow:\r\n\r\nHBsAg negative, HBcAb negative, HBsAb negative patients are eligible.\r\nHBsAg negative, HBcAb negative, HBsAb positive patients are eligible.\r\nPatients who test positive for HBsAg are ineligible\r\nPatients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a HBV DNA testing performed and protocol eligibility determined as follow:\r\n\r\nIf HBV DNA is positive, the subject is ineligible.\r\nIf HBV DNA is negative, the subject may be included but must undergo HBV DNA PCR testing monthly x 3 months beginning from the start of treatment\r\nSubjects must have the ability to understand and the willingness to sign a written informed consent document.\r\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 30 days after the last dose of venetoclax or 18 months after the last dose of rituximab, whichever is longer.\r\nA woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).\r\n\r\nFor men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\r\nWith female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of rituximab. Men must refrain from donating sperm during this same period.\r\n\r\nWith pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of rituximab to avoid exposing the embryo.""}",{'Arm - Disease - Indication': 'Relapsed/\u200bRefractory Diffuse Large B-Cell Lymphoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04308785,"{'Official Title': 'A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 2 Study to Investigate the Efficacy and Safety of Atezolizumab With or Without Tiragolumab as Consolidation Therapy in Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy\n', 'Brief Summary': 'This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy.\n', 'Condition': 'Carcinoma, Small Cell Lung\n', 'Detailed Description': 'Participants can receive concurrent or sequential chemoradiotherapy (CRT) as per local standard of care, but they must be randomized within 6 weeks from completion of chemoradiotherapy. Participants should receive 4 cycles of chemotherapy and radiotherapy dose of 56-64 Gy (once daily) before randomization, and those participants who have not progressed during/after CRT will be stratified by response to CRT, radiotherapy timing, and be randomized in a 1:1 ratio to Atezolizumab+Tiragolumab arm or Atezolizumab+placebo arm.\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nSigned Informed Consent Form\nECOG performance status of 0 or 1\nHistologically confirmed limited-stage SCLC.\nPatients who have not progressed during/after chemoradiotherapy.\nConcurrent or sequential chemoradiotherapy per local clinical practice must have been completed within 6 weeks prior to the first study treatment. If concurrent CRT is used, at least two cycles of chemotherapy should have been conducted during radiotherapy. If sequential radiotherapy is used, induction chemotherapy should be given 2 cycles of chemotherapy before thoracic radiotherapy.\nAdequate hematologic and end organ function.\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the final dose of atezolizumab or placebo, and 90 days after the final dose of tiragolumab or placebo, and 6 months for chemotherapy after the last dose of chemotherapy treatment, whichever is later.\nFor men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm.\nPatients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior therapy.\nPatients must submit a pre-treatment tumor tissue sample.'}",{'Arm - Disease - Indication': 'Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04308785,"{'Official Title': 'A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 2 Study to Investigate the Efficacy and Safety of Atezolizumab With or Without Tiragolumab as Consolidation Therapy in Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy\n', 'Brief Summary': 'This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy.\n', 'Condition': 'Carcinoma, Small Cell Lung\n', 'Detailed Description': 'Participants can receive concurrent or sequential chemoradiotherapy (CRT) as per local standard of care, but they must be randomized within 6 weeks from completion of chemoradiotherapy. Participants should receive 4 cycles of chemotherapy and radiotherapy dose of 56-64 Gy (once daily) before randomization, and those participants who have not progressed during/after CRT will be stratified by response to CRT, radiotherapy timing, and be randomized in a 1:1 ratio to Atezolizumab+Tiragolumab arm or Atezolizumab+placebo arm.\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nSigned Informed Consent Form\nECOG performance status of 0 or 1\nHistologically confirmed limited-stage SCLC.\nPatients who have not progressed during/after chemoradiotherapy.\nConcurrent or sequential chemoradiotherapy per local clinical practice must have been completed within 6 weeks prior to the first study treatment. If concurrent CRT is used, at least two cycles of chemotherapy should have been conducted during radiotherapy. If sequential radiotherapy is used, induction chemotherapy should be given 2 cycles of chemotherapy before thoracic radiotherapy.\nAdequate hematologic and end organ function.\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the final dose of atezolizumab or placebo, and 90 days after the final dose of tiragolumab or placebo, and 6 months for chemotherapy after the last dose of chemotherapy treatment, whichever is later.\nFor men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm.\nPatients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior therapy.\nPatients must submit a pre-treatment tumor tissue sample.'}",{'Arm - Disease - Indication': 'Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01843374,"{'Official Title': 'A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Brief Summary': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period', 'Condition': 'Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Detailed Description': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo.\r\n\r\nRandomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy (second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the EORTC to stratify subjects into high or low risk groups in order to ensure balanced randomization to the different treatment groups. For subjects in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required. Approximately 564 subjects will be enrolled at study centers in multiple countries.\r\n\r\nThe study consists of a screening period, a treatment period, and a 90-day follow-up period', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma;\r\nDisease not amenable to curative surgery;\r\nAge 18 and over at the time of consent;\r\nECOG Performance status 0-1;\r\nProgressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent.\r\nRecovered from all toxicities associated with prior treatment, to acceptable baseline status, or a NCI CTCAE Grade of 0 or\r\n1, except for toxicities not considered a safety risk, 7. Measurable diseaseby modified RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma; 8. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization defined as: 9. Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C. 10. Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol- related procedures, including screening evaluations; 11. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. 2. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Days 1 through 90 post last dose. In addition, they must refrain from sperm donation for 90 days after the final dose of investigational product.'}",{'Arm - Disease - Indication': 'Second- or Third-line Unresectable Pleural or Peritoneal Malignant Mesothelioma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01843374,"{'Official Title': 'A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Brief Summary': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period', 'Condition': 'Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Detailed Description': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo.\r\n\r\nRandomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy (second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the EORTC to stratify subjects into high or low risk groups in order to ensure balanced randomization to the different treatment groups. For subjects in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required. Approximately 564 subjects will be enrolled at study centers in multiple countries.\r\n\r\nThe study consists of a screening period, a treatment period, and a 90-day follow-up period', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma;\r\nDisease not amenable to curative surgery;\r\nAge 18 and over at the time of consent;\r\nECOG Performance status 0-1;\r\nProgressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent.\r\nRecovered from all toxicities associated with prior treatment, to acceptable baseline status, or a NCI CTCAE Grade of 0 or\r\n1, except for toxicities not considered a safety risk, 7. Measurable diseaseby modified RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma; 8. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization defined as: 9. Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C. 10. Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol- related procedures, including screening evaluations; 11. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. 2. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Days 1 through 90 post last dose. In addition, they must refrain from sperm donation for 90 days after the final dose of investigational product.'}",{'Arm - Disease - Indication': 'Second- or Third-line Unresectable Pleural or Peritoneal Malignant Mesothelioma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03504397,"{'Official Title': 'A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Brief Summary': 'A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.\n\nWhy is this study being done?\n\nSPOTLIGHT is a new clinical study for adult patients who have any of:\n\nadvanced unresectable gastric or GEJ cancer\nmetastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.\nFor patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.\n\nPatients will be assigned to one of two groups by chance and given either:\n\nzolbetuximab with mFOLFOX6; or\na placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.\nThe goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.', 'Condition': 'Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Detailed Description': 'The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nFemale subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:\n\nNot a woman of child-bearing potential (WOCBP) OR\nWOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs\nFemale subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nFemale subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.\nA sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.\nMale subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nMale subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.\nSubject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.\nSubject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.\nSubject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\nSubject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.\nSubject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.\nSubject has ECOG performance status 0 to 1.\nSubject has predicted life expectancy ≥ 12 weeks.\nSubject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.\n\nHemoglobin (Hgb) ≥ 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.\nAbsolute neutrophil count (ANC) ≥ 1.5 x 10^9/L\nPlatelets ≥ 100 x 10^9/L\nAlbumin ≥ 2.5 g/dL\nTotal bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)\nEstimated creatinine clearance ≥ 30 mL/min\nProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)""}","{'Arm - Disease - Indication': 'Adult Claudin 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma'}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03504397,"{'Official Title': 'A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Brief Summary': 'A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.\n\nWhy is this study being done?\n\nSPOTLIGHT is a new clinical study for adult patients who have any of:\n\nadvanced unresectable gastric or GEJ cancer\nmetastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.\nFor patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.\n\nPatients will be assigned to one of two groups by chance and given either:\n\nzolbetuximab with mFOLFOX6; or\na placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.\nThe goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.', 'Condition': 'Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Detailed Description': 'The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nFemale subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:\n\nNot a woman of child-bearing potential (WOCBP) OR\nWOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs\nFemale subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nFemale subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.\nA sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.\nMale subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nMale subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.\nSubject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.\nSubject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.\nSubject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\nSubject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.\nSubject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.\nSubject has ECOG performance status 0 to 1.\nSubject has predicted life expectancy ≥ 12 weeks.\nSubject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.\n\nHemoglobin (Hgb) ≥ 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.\nAbsolute neutrophil count (ANC) ≥ 1.5 x 10^9/L\nPlatelets ≥ 100 x 10^9/L\nAlbumin ≥ 2.5 g/dL\nTotal bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)\nEstimated creatinine clearance ≥ 30 mL/min\nProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)""}","{'Arm - Disease - Indication': 'Adult Claudin 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma'}",0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01004978,"{'Official Title': 'A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion', 'Brief Summary': 'This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.', 'Condition': 'Hepatocellular Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\r\n\r\nI. To compare progression-free survival (PFS) of chemoembolization alone to sorafenib (sorafenib tosylate) in combination with chemoembolization.\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To compare overall survival (OS) of chemoembolization alone to sorafenib in combination with chemoembolization.\r\n\r\nII. To evaluate extra-hepatic versus intra-hepatic patterns of failure. III. To determine the rates of toxicity related to sorafenib in combination with chemoembolization.\r\n\r\nTERTIARY OBJECTIVES:\r\n\r\nI. To analyze the pharmacogenetic and pharmacokinetic properties of sorafenib including angiogenesis, monooxygenases, polymorphisms and multidrug resistance (MDR).\r\n\r\nII. Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) secondary imaging objective: site versus (vs.) central evaluation of PFS.\r\n\r\nIII. To determine the inter-reader concordance for response characterization at four and eight months by the European Association for the Study of Liver (EASL) criteria.\r\n\r\nIV. To determine the value of objective tumor response at four and eight months by the EASL criteria to predict PFS (by Response Evaluation Criteria in Solid Tumors [RECIST]) and OS.\r\n\r\nV. To evaluate the effects of intra-hepatic vs. extra-hepatic progression on OS.\r\n\r\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\r\n\r\nARM A: Patients receive sorafenib tosylate at 400 mg orally (PO) twice daily (BID) in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of sorafenib tosylate is reached, patients undergo transarterial chemoembolization (TACE) comprising doxorubicin hydrochloride, mitomycin C, and cisplatin (closed to accrual as of 10/1/2010); conventional chemoembolization comprising doxorubicin hydrochloride only; or chemoembolization comprising doxorubicin-eluting beads. Treatment with TACE repeats approximately every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.\r\n\r\nARM B: Patients receive placebo PO BID in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of placebo is reached, patients undergo TACE as in Arm A.\r\n\r\nMAINTENANCE THERAPY: After completion of chemoembolization, patients receive sorafenib tosylate or placebo as in Arm A and B in the absence of disease progression or unacceptable toxicity.\r\n\r\nAfter completion of study treatment, patients are followed up for 4 years.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:\r\n\r\nHistologically confirmed\r\nMagnetic resonance imaging (MRI) or computerized tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion > 2 cm with early enhancement and delayed enhancement washout regardless of alpha-feto protein levels (AFP)\r\nAFP > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless of specific imaging characteristics on CT or MRI\r\nPatients must have hepatocellular carcinoma (HCC) limited to the liver\r\nPortal lymphadenopathy is permitted for patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) - as lymphadenopathy is commonly associated with hepatitis unrelated to malignancy\r\nStaging CT of the chest and CT or MRI of the abdomen and pelvis must have been completed within 4 weeks of study registration\r\nPatients must have measurable disease constituting < 50% of liver parenchyma within 4 weeks of registration\r\nPatients may have been treated with RFA in the past, but no sooner than 4 weeks before study registration\r\nPatients may have undergone previously attempted curative liver resection\r\nBranch portal vein invasion by tumor is permitted\r\nPatients must have Child-Pugh score of A or B7 within 4 weeks prior to study registration\r\nSerum total bilirubin =< 2.0 mg/dL\r\nAlkaline phosphatase < 5 x upper limit of normal (ULN)\r\nAspartate aminotransferase (AST), alanine aminotransferase (ALT) < 5 x ULN\r\nSerum creatinine =< 1.5 mg/dL\r\nPlatelet count >= 50,000/mm^3\r\nPatients must meet New York Heart Association functional classification I or II defined as:\r\n\r\nClass I - patients with no limitation of activities; they suffer no symptoms from ordinary activities\r\nClass II - patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion\r\nPatients must have an ECOG performance status of 0 or 1\r\nPatients must have a life expectancy of at least 3 months\r\nWomen of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception\r\nPatient must be able to swallow pills, as study medications cannot be crushed'}",{'Arm - Disease - Indication': 'Unresectable Hepatocellular Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01004978,"{'Official Title': 'A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion', 'Brief Summary': 'This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.', 'Condition': 'Hepatocellular Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\r\n\r\nI. To compare progression-free survival (PFS) of chemoembolization alone to sorafenib (sorafenib tosylate) in combination with chemoembolization.\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To compare overall survival (OS) of chemoembolization alone to sorafenib in combination with chemoembolization.\r\n\r\nII. To evaluate extra-hepatic versus intra-hepatic patterns of failure. III. To determine the rates of toxicity related to sorafenib in combination with chemoembolization.\r\n\r\nTERTIARY OBJECTIVES:\r\n\r\nI. To analyze the pharmacogenetic and pharmacokinetic properties of sorafenib including angiogenesis, monooxygenases, polymorphisms and multidrug resistance (MDR).\r\n\r\nII. Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) secondary imaging objective: site versus (vs.) central evaluation of PFS.\r\n\r\nIII. To determine the inter-reader concordance for response characterization at four and eight months by the European Association for the Study of Liver (EASL) criteria.\r\n\r\nIV. To determine the value of objective tumor response at four and eight months by the EASL criteria to predict PFS (by Response Evaluation Criteria in Solid Tumors [RECIST]) and OS.\r\n\r\nV. To evaluate the effects of intra-hepatic vs. extra-hepatic progression on OS.\r\n\r\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\r\n\r\nARM A: Patients receive sorafenib tosylate at 400 mg orally (PO) twice daily (BID) in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of sorafenib tosylate is reached, patients undergo transarterial chemoembolization (TACE) comprising doxorubicin hydrochloride, mitomycin C, and cisplatin (closed to accrual as of 10/1/2010); conventional chemoembolization comprising doxorubicin hydrochloride only; or chemoembolization comprising doxorubicin-eluting beads. Treatment with TACE repeats approximately every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.\r\n\r\nARM B: Patients receive placebo PO BID in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of placebo is reached, patients undergo TACE as in Arm A.\r\n\r\nMAINTENANCE THERAPY: After completion of chemoembolization, patients receive sorafenib tosylate or placebo as in Arm A and B in the absence of disease progression or unacceptable toxicity.\r\n\r\nAfter completion of study treatment, patients are followed up for 4 years.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:\r\n\r\nHistologically confirmed\r\nMagnetic resonance imaging (MRI) or computerized tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion > 2 cm with early enhancement and delayed enhancement washout regardless of alpha-feto protein levels (AFP)\r\nAFP > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless of specific imaging characteristics on CT or MRI\r\nPatients must have hepatocellular carcinoma (HCC) limited to the liver\r\nPortal lymphadenopathy is permitted for patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) - as lymphadenopathy is commonly associated with hepatitis unrelated to malignancy\r\nStaging CT of the chest and CT or MRI of the abdomen and pelvis must have been completed within 4 weeks of study registration\r\nPatients must have measurable disease constituting < 50% of liver parenchyma within 4 weeks of registration\r\nPatients may have been treated with RFA in the past, but no sooner than 4 weeks before study registration\r\nPatients may have undergone previously attempted curative liver resection\r\nBranch portal vein invasion by tumor is permitted\r\nPatients must have Child-Pugh score of A or B7 within 4 weeks prior to study registration\r\nSerum total bilirubin =< 2.0 mg/dL\r\nAlkaline phosphatase < 5 x upper limit of normal (ULN)\r\nAspartate aminotransferase (AST), alanine aminotransferase (ALT) < 5 x ULN\r\nSerum creatinine =< 1.5 mg/dL\r\nPlatelet count >= 50,000/mm^3\r\nPatients must meet New York Heart Association functional classification I or II defined as:\r\n\r\nClass I - patients with no limitation of activities; they suffer no symptoms from ordinary activities\r\nClass II - patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion\r\nPatients must have an ECOG performance status of 0 or 1\r\nPatients must have a life expectancy of at least 3 months\r\nWomen of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception\r\nPatient must be able to swallow pills, as study medications cannot be crushed'}",{'Arm - Disease - Indication': 'Unresectable Hepatocellular Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04543617,"{'Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy\n', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).\n', 'Condition': 'Esophageal Squamous Cell Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\nHistologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus\nUnresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study\ndCRT treatment according to regional oncology guidelines for esophageal cancer\nRepresentative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT\nAdequate hematologic and end-organ function prior to randomization\nWomen of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later\nMen must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.'}",{'Arm - Disease - Indication': 'Unresectable Esophageal Squamous Cell Carcinoma Non-Progressive Following Definitive Concurrent Chemoradiotherapy '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04543617,"{'Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy\n', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).\n', 'Condition': 'Esophageal Squamous Cell Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\nHistologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus\nUnresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study\ndCRT treatment according to regional oncology guidelines for esophageal cancer\nRepresentative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT\nAdequate hematologic and end-organ function prior to randomization\nWomen of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later\nMen must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.'}",{'Arm - Disease - Indication': 'Unresectable Esophageal Squamous Cell Carcinoma Non-Progressive Following Definitive Concurrent Chemoradiotherapy '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04543617,"{'Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy\n', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).\n', 'Condition': 'Esophageal Squamous Cell Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\nHistologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus\nUnresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study\ndCRT treatment according to regional oncology guidelines for esophageal cancer\nRepresentative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT\nAdequate hematologic and end-organ function prior to randomization\nWomen of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later\nMen must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.'}",{'Arm - Disease - Indication': 'Unresectable Esophageal Squamous Cell Carcinoma Non-Progressive Following Definitive Concurrent Chemoradiotherapy '},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05904886,"{'Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma\n', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).\n', 'Condition': 'Carcinoma, Hepatocellular\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nLocally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants\nDisease that is not amenable to curative surgical and/or locoregional therapies\nNo prior systemic treatment for locally advanced or metastatic and/or unresectable HCC\nMeasurable disease according to RECIST v1.1\nECOG Performance Status of 0 or 1 within 7 days prior to randomization\nChild-Pugh Class A within 7 days prior to randomization\nAdequate hematologic and end-organ function\nFemale participants of childbearing potential must be willing to avoid pregnancy\nMale participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab to avoid exposing the embryo.'}",{'Arm - Disease - Indication': 'First-Line Untreated Locally Advanced or Metastatic and/or Unresectable Hepatocellular Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05904886,"{'Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma\n', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).\n', 'Condition': 'Carcinoma, Hepatocellular\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nLocally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants\nDisease that is not amenable to curative surgical and/or locoregional therapies\nNo prior systemic treatment for locally advanced or metastatic and/or unresectable HCC\nMeasurable disease according to RECIST v1.1\nECOG Performance Status of 0 or 1 within 7 days prior to randomization\nChild-Pugh Class A within 7 days prior to randomization\nAdequate hematologic and end-organ function\nFemale participants of childbearing potential must be willing to avoid pregnancy\nMale participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab to avoid exposing the embryo.'}",{'Arm - Disease - Indication': 'First-Line Untreated Locally Advanced or Metastatic and/or Unresectable Hepatocellular Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03592472,"{'Official Title': 'A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV)\n', 'Brief Summary': 'This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).\n', 'Condition': 'Renal Cell Carcinoma\n', 'Detailed Description': 'In this randomized, Phase 3, double-blind, placebo-controlled study, patients will be randomized 2:1 to receive either a combination of pazopanib plus abexinostat or pazopanib plus placebo. At the time of disease progression, patient treatment assignment will be unblinded, and those patients randomized to the pazopanib plus placebo treatment arm will have the option of crossing over to receive treatment with a combination of pazopanib plus abexinostat. After providing written informed consent, patients will be screened for study eligibility within 28 days before their first dose of study drug. After screening assessments, patients who are eligible for inclusion in the study will be randomized and receive their first dose of study drug on Cycle 1 Day 1 (C1D1), within 7 days of randomization. A treatment cycle is 28 days in length. Patients may continue to receive study drug until any of the following events: the development of IRC-verified radiographic progression as assessed by RECIST version 1.1, clinical disease progression, unacceptable toxicity, another discontinuation criterion is met, withdrawal of consent, or closure of the study by the sponsor. No maximum duration of therapy has been set.\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nTo be enrolled in the study, patients will be required to meet all of the following criteria:\n\nPatients aged ≥ 18 years at time of study entry.\nPatients have histologically confirmed RCC with clear cell component.\nPatients have locally advanced and unresectable or metastatic disease.\nMeasurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.\nPatients must not have had any prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced/metastatic setting. Up to 1 line of prior cytokine or immune checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment.\nPatients have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\nPatients have adequate baseline organ function.\nPatients have adequate baseline hematologic function\nPatient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.'}",{'Arm - Disease - Indication': 'Unresectable Locally Advanced or Metastatic Renal Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03592472,"{'Official Title': 'A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV)\n', 'Brief Summary': 'This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).\n', 'Condition': 'Renal Cell Carcinoma\n', 'Detailed Description': 'In this randomized, Phase 3, double-blind, placebo-controlled study, patients will be randomized 2:1 to receive either a combination of pazopanib plus abexinostat or pazopanib plus placebo. At the time of disease progression, patient treatment assignment will be unblinded, and those patients randomized to the pazopanib plus placebo treatment arm will have the option of crossing over to receive treatment with a combination of pazopanib plus abexinostat. After providing written informed consent, patients will be screened for study eligibility within 28 days before their first dose of study drug. After screening assessments, patients who are eligible for inclusion in the study will be randomized and receive their first dose of study drug on Cycle 1 Day 1 (C1D1), within 7 days of randomization. A treatment cycle is 28 days in length. Patients may continue to receive study drug until any of the following events: the development of IRC-verified radiographic progression as assessed by RECIST version 1.1, clinical disease progression, unacceptable toxicity, another discontinuation criterion is met, withdrawal of consent, or closure of the study by the sponsor. No maximum duration of therapy has been set.\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nTo be enrolled in the study, patients will be required to meet all of the following criteria:\n\nPatients aged ≥ 18 years at time of study entry.\nPatients have histologically confirmed RCC with clear cell component.\nPatients have locally advanced and unresectable or metastatic disease.\nMeasurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.\nPatients must not have had any prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced/metastatic setting. Up to 1 line of prior cytokine or immune checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment.\nPatients have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\nPatients have adequate baseline organ function.\nPatients have adequate baseline hematologic function\nPatient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.'}",{'Arm - Disease - Indication': 'Unresectable Locally Advanced or Metastatic Renal Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03941860,"{'Official Title': 'Optimizing Prolonged Treatment In Myeloma Using MRD Assessment (OPTIMUM)', 'Brief Summary': 'This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.', 'Condition': 'Multiple Myeloma', 'Detailed Description': 'PRIMARY OBJECTIVE:\r\n\r\nI. To evaluate whether escalating maintenance therapy with the addition of ixazomib citrate (ixazomib) to lenalidomide improves overall survival (OS) among patients who are minimal residual disease (MRD) positive after approximately 1 year of lenalidomide maintenance following an early stem cell transplant (=< 12 months from diagnosis).\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To establish whether progression-free survival (PFS) is superior with the addition of ixazomib to lenalidomide maintenance.\r\n\r\nII. To evaluate best response on treatment and compare response rates between arms.\r\n\r\nIII. To evaluate the safety profile of ixazomib added to lenalidomide and compare toxicity rates between arms.\r\n\r\nEXPLORATORY OBJECTIVES:\r\n\r\nI. To measure treatment exposure and adherence. II. To estimate treatment duration, duration of response and time to progression.\r\n\r\nPATIENT-REPORTED OUTCOMES (PRO) OBJECTIVES:\r\n\r\nI. To quantify the extent to which the addition of ixazomib to lenalidomide maintenance contributes to neuropathy and associated physical and functional impairments. (Primary) II. To assess the impact of the addition of ixazomib to lenalidomide maintenance on disease control and associated physical and functional well-being. (Primary) III. To evaluate time to worsening and recovery rate related to neuropathy. (Secondary) IV. To evaluate time to improvement and response rate related to disease control. (Secondary) V. To evaluate attributes of select patient reported treatment-emergent symptomatic adverse events (Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events [PRO-CTCAE]) longitudinally and compare responses with provider-reported adverse events. (Exploratory) VI. To measure the likelihood of medication adherence and examine the relationship with treatment exposure. (Exploratory) VII. To assess correlation among patient reported outcome measures and association with clinical outcomes. (Exploratory) VIII. To tabulate PRO compliance and completion rates. (Exploratory)\r\n\r\nIMAGING OBJECTIVES:\r\n\r\nI. To evaluate the association between baseline fludeoxyglucose F-18 (18F-FDG)-positron emission tomography (PET)/computed tomography (CT) and patient outcomes.\r\n\r\nII. To compare overall survival (OS) with the addition of ixazomib to lenalidomide among baseline 18F-FDG PET/CT-positive and 18F-FDG PET/CT -negative subgroups.\r\n\r\nIII. To compare the change in quantitative 18F-FDG PET/CT parameters over time with the addition of ixazomib to lenalidomide.\r\n\r\nOUTLINE: Patients are randomized to 1 of 2 arms.\r\n\r\nARM A: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-28 and ixazomib citrate PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and positron emission tomography (PET) and computed tomography (CT) scan at screening and on study as well as undergo collection of blood samples throughout the trial.\r\n\r\nARM B: Patients receive lenalidomide PO QD on days 1-28 and a placebo PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial.\r\n\r\nAfter completion of study treatment, patients are followed up every 3 months if < 2 years from study entry, every 6 months if 2-5 years from study entry, then every 12 months for up to 10 years from study entry.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nSTEP 0: PRE-REGISTRATION\r\nPatient must be >= 18 years of age\r\nPatient must be previously diagnosed with multiple myeloma (MM) and be on lenalidomide maintenance with >= 5mg daily for at least 6 months and no more than 18 months after an early autologous stem cell transplantation (SCT =< 12 months of diagnosis). Patient must not be off lenalidomide maintenance therapy for more than 30 days prior to start of treatment on Step 1 of this protocol\r\nPatient must be able to undergo a diagnostic bone marrow aspirate following pre-registration to Step 0\r\n\r\nNOTE: A bone marrow aspirate specimen must be submitted to Mayo Clinic Hematology Laboratory for central assessment of minimal residual disease (MRD) status to confirm patient's eligibility for Step 1 randomization. Mayo Clinic will forward results to the submitting institution within three (3) business days of receipt of the bone marrow specimen\r\nPatient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2\r\nPatient must have been able to maintain at least 5mg daily dose of lenalidomide without growth factor support\r\nHuman immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\r\nSTEP 1 RANDOMIZATION\r\nPatient must meet Step 0 eligibility criteria at the time of Step 1 randomization\r\nPatients must have evidence of residual disease by central MRD testing or by presence of monoclonal protein in serum or urine\r\nPatient must have serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) performed =< 28 days prior to randomization\r\n\r\nNOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hour (hr). Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response\r\nHemoglobin >= 8 g/dL (obtained =< 14 days prior to randomization)\r\nUntransfused platelet count >= 75,000 cells/mm^3 (obtained =< 14 days prior to randomization)\r\nAbsolute neutrophil count (ANC) >= 1000 cells/mm^3 (obtained =< 14 days prior to randomization)\r\nCalculated creatinine clearance >= 30 mL/min (obtained =< 14 days prior to randomization)\r\nTotal bilirubin =< 1.5 times the upper limit of normal (ULN) (obtained =< 14 days prior to randomization)\r\nSerum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 times the upper limit of normal (ULN) (obtained =< 14 days prior to randomization)\r\nPatient must agree to register into the mandatory Revlimid Risk Evaluation and Mitigation Strategies (REMS) registered trademark program and be willing and able to comply with the requirements of Revlimid REMS registered trademark\r\nPatients of childbearing potential must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 90 days after the last dose of protocol treatment. Patients must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a partner of childbearing potential while participating in the study and for 90 days after the last dose of protocol treatment even if they have had a successful vasectomy. Patients must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. All patients must agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment""}",{'Arm - Disease - Indication': 'Previously treated residual Multiple Myeloma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03941860,"{'Official Title': 'Optimizing Prolonged Treatment In Myeloma Using MRD Assessment (OPTIMUM)', 'Brief Summary': 'This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.', 'Condition': 'Multiple Myeloma', 'Detailed Description': 'PRIMARY OBJECTIVE:\r\n\r\nI. To evaluate whether escalating maintenance therapy with the addition of ixazomib citrate (ixazomib) to lenalidomide improves overall survival (OS) among patients who are minimal residual disease (MRD) positive after approximately 1 year of lenalidomide maintenance following an early stem cell transplant (=< 12 months from diagnosis).\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To establish whether progression-free survival (PFS) is superior with the addition of ixazomib to lenalidomide maintenance.\r\n\r\nII. To evaluate best response on treatment and compare response rates between arms.\r\n\r\nIII. To evaluate the safety profile of ixazomib added to lenalidomide and compare toxicity rates between arms.\r\n\r\nEXPLORATORY OBJECTIVES:\r\n\r\nI. To measure treatment exposure and adherence. II. To estimate treatment duration, duration of response and time to progression.\r\n\r\nPATIENT-REPORTED OUTCOMES (PRO) OBJECTIVES:\r\n\r\nI. To quantify the extent to which the addition of ixazomib to lenalidomide maintenance contributes to neuropathy and associated physical and functional impairments. (Primary) II. To assess the impact of the addition of ixazomib to lenalidomide maintenance on disease control and associated physical and functional well-being. (Primary) III. To evaluate time to worsening and recovery rate related to neuropathy. (Secondary) IV. To evaluate time to improvement and response rate related to disease control. (Secondary) V. To evaluate attributes of select patient reported treatment-emergent symptomatic adverse events (Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events [PRO-CTCAE]) longitudinally and compare responses with provider-reported adverse events. (Exploratory) VI. To measure the likelihood of medication adherence and examine the relationship with treatment exposure. (Exploratory) VII. To assess correlation among patient reported outcome measures and association with clinical outcomes. (Exploratory) VIII. To tabulate PRO compliance and completion rates. (Exploratory)\r\n\r\nIMAGING OBJECTIVES:\r\n\r\nI. To evaluate the association between baseline fludeoxyglucose F-18 (18F-FDG)-positron emission tomography (PET)/computed tomography (CT) and patient outcomes.\r\n\r\nII. To compare overall survival (OS) with the addition of ixazomib to lenalidomide among baseline 18F-FDG PET/CT-positive and 18F-FDG PET/CT -negative subgroups.\r\n\r\nIII. To compare the change in quantitative 18F-FDG PET/CT parameters over time with the addition of ixazomib to lenalidomide.\r\n\r\nOUTLINE: Patients are randomized to 1 of 2 arms.\r\n\r\nARM A: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-28 and ixazomib citrate PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and positron emission tomography (PET) and computed tomography (CT) scan at screening and on study as well as undergo collection of blood samples throughout the trial.\r\n\r\nARM B: Patients receive lenalidomide PO QD on days 1-28 and a placebo PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial.\r\n\r\nAfter completion of study treatment, patients are followed up every 3 months if < 2 years from study entry, every 6 months if 2-5 years from study entry, then every 12 months for up to 10 years from study entry.', 'Inclusion Criteria': ""Inclusion Criteria:\r\n\r\nSTEP 0: PRE-REGISTRATION\r\nPatient must be >= 18 years of age\r\nPatient must be previously diagnosed with multiple myeloma (MM) and be on lenalidomide maintenance with >= 5mg daily for at least 6 months and no more than 18 months after an early autologous stem cell transplantation (SCT =< 12 months of diagnosis). Patient must not be off lenalidomide maintenance therapy for more than 30 days prior to start of treatment on Step 1 of this protocol\r\nPatient must be able to undergo a diagnostic bone marrow aspirate following pre-registration to Step 0\r\n\r\nNOTE: A bone marrow aspirate specimen must be submitted to Mayo Clinic Hematology Laboratory for central assessment of minimal residual disease (MRD) status to confirm patient's eligibility for Step 1 randomization. Mayo Clinic will forward results to the submitting institution within three (3) business days of receipt of the bone marrow specimen\r\nPatient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2\r\nPatient must have been able to maintain at least 5mg daily dose of lenalidomide without growth factor support\r\nHuman immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\r\nSTEP 1 RANDOMIZATION\r\nPatient must meet Step 0 eligibility criteria at the time of Step 1 randomization\r\nPatients must have evidence of residual disease by central MRD testing or by presence of monoclonal protein in serum or urine\r\nPatient must have serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) performed =< 28 days prior to randomization\r\n\r\nNOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hour (hr). Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response\r\nHemoglobin >= 8 g/dL (obtained =< 14 days prior to randomization)\r\nUntransfused platelet count >= 75,000 cells/mm^3 (obtained =< 14 days prior to randomization)\r\nAbsolute neutrophil count (ANC) >= 1000 cells/mm^3 (obtained =< 14 days prior to randomization)\r\nCalculated creatinine clearance >= 30 mL/min (obtained =< 14 days prior to randomization)\r\nTotal bilirubin =< 1.5 times the upper limit of normal (ULN) (obtained =< 14 days prior to randomization)\r\nSerum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 times the upper limit of normal (ULN) (obtained =< 14 days prior to randomization)\r\nPatient must agree to register into the mandatory Revlimid Risk Evaluation and Mitigation Strategies (REMS) registered trademark program and be willing and able to comply with the requirements of Revlimid REMS registered trademark\r\nPatients of childbearing potential must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 90 days after the last dose of protocol treatment. Patients must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a partner of childbearing potential while participating in the study and for 90 days after the last dose of protocol treatment even if they have had a successful vasectomy. Patients must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. All patients must agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment""}",{'Arm - Disease - Indication': 'Previously treated residual Multiple Myeloma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04199104,"{'Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.\n\nHypotheses include:\n\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.\nNote: Participants with newly-diagnosed HNSCC must be M1/Stage IV.\n\nHas a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.\nNote: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.\n\nContraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\n\nMale participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period\nFemale participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last\nHas measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions.\nParticipants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.\nHas an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.\nHas adequately controlled blood pressure with or without antihypertensive medications.\nHas adequate organ function.'}",{'Arm - Disease - Indication': 'First Line PD-L1 Positive Recurrent or Metastatic Stage IV Head and Neck Squamous Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04199104,"{'Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.\n\nHypotheses include:\n\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.\nNote: Participants with newly-diagnosed HNSCC must be M1/Stage IV.\n\nHas a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.\nNote: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.\n\nContraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\n\nMale participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period\nFemale participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last\nHas measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions.\nParticipants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.\nHas an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.\nHas adequately controlled blood pressure with or without antihypertensive medications.\nHas adequate organ function.'}",{'Arm - Disease - Indication': 'First Line PD-L1 Positive Recurrent or Metastatic Stage IV Head and Neck Squamous Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05523323,"{'Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.\r\n\r\nHypotheses include:\r\n\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': 'The MK-7902-010-China Extension Study will include participants previously enrolled in China in the global study for MK-7902-010 (NCT04199104) plus those enrolled during the China extension enrollment period.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n- Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.\r\n\r\nNote: Participants with newly-diagnosed HNSCC must be M1/Stage IV.\r\n\r\n- Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.\r\n\r\nNote: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.\r\n\r\nContraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\r\n\r\nMale participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period\r\nFemale participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last\r\nHas measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions.\r\nParticipants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.\r\nHas an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.\r\nHas adequately controlled blood pressure with or without antihypertensive medications.\r\nHas adequate organ function.'}",{'Arm - Disease - Indication': 'First-Line PD-L1 mutated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05523323,"{'Official Title': 'A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).', 'Brief Summary': 'This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.\r\n\r\nHypotheses include:\r\n\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.\r\nPembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).', 'Condition': 'Head and Neck Squamous Cell Carcinoma', 'Detailed Description': 'The MK-7902-010-China Extension Study will include participants previously enrolled in China in the global study for MK-7902-010 (NCT04199104) plus those enrolled during the China extension enrollment period.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n- Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.\r\n\r\nNote: Participants with newly-diagnosed HNSCC must be M1/Stage IV.\r\n\r\n- Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.\r\n\r\nNote: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.\r\n\r\nContraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\r\n\r\nMale participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period\r\nFemale participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last\r\nHas measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions.\r\nParticipants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.\r\nHas an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.\r\nHas adequately controlled blood pressure with or without antihypertensive medications.\r\nHas adequate organ function.'}",{'Arm - Disease - Indication': 'First-Line PD-L1 mutated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03598270,"{'Official Title': 'A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months', 'Brief Summary': 'Atezolizumab in this study is expected to have a positive benefit-risk profile for the treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest, atezolizumab is being investigated also in combination with platinum-based doublet chemotherapy in second line (2L)/ third line (3L) platinum-sensitive recurrent ovarian cancer patients in ATALANTE (NCT02891824), which also includes bevacizumab in the combination. The study is proceeding as expected after >100 patients enrolled and under independent Data Monitoring Committee (IDMC) supervision.\n\nPlatinum-containing therapy is considered the treatment of choice for patients with platinum-sensitive relapse. However the duration of response and the prolongation of the progression free interval with chemotherapy are usually brief, among other because these chemotherapy regimens cannot be continued until progression as they are associated with neurological, renal and hematological toxicity and cannot generally be tolerated for more than about 6 to 9 cycles.\n\nNiraparib received FDA approval in March 2017 as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Recently, the European Medicines Agency (EMA) has also approved niraparib as maintenance monotherapy. Despite the progress brought about by niraparib, there is a need for a more effective treatment to extend the progression free interval in this patient population. The combination with immune checkpoint inhibitors such as anti-death protein 1 (anti-PD1) or anti-death protein ligand 1 (anti-PD-L1) has a compelling rationale to this aim, especially under the light of the emerging clinical data of this combination.\n\nThe use of atezolizumab concurrent to platinum-containing chemotherapy followed by niraparib as maintenance therapy after completion of chemotherapy, as per normal clinical practice, may provide further benefit to patients in terms of prolonging the progression free interval and increasing the interval between lines of chemotherapy, hence delaying further hospitalization and the cumulative toxicities associated with chemotherapy. Additionally, preliminary studies with atezolizumab suggest an acceptable tolerability profile for long term clinical use in recurrent ovarian cancer patients and other indications.', 'Condition': 'Recurrent Ovarian Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients ≥ 18 years old\r\nLife expectancy ≥3 months\r\nSigned informed consent and ability to comply with treatment and follow-up\r\nHistologically confirmed diagnosis (cytology alone excluded) of high- grade serous or endometrioid ovarian, primary peritoneal or tubal carcinoma.\r\nBreast Cancer (BRCA) mutational status is known (germline or somatic)\r\nRelapsed disease more than 6 months after the last platinum dose\r\nNo more than 2 prior lines of chemotherapy are allowed, and the last one must contain a platinum-based regimen\r\nAt least one measurable lesion to assess response by RECIST v1.1 criteria.\r\nMandatory de novo tumor biopsy (collected within 3 months prior to randomization) sent to HistoGene X as a formalin-fixed, paraffin-embedded (FFPE) sample for PD-L1 status determination for randomization. The inclusion of patients with non informative tissue PD-L1 status will be capped to 10% of the whole study population:\r\n\r\nIf the mandatory de novo biopsy is technically not possible or failed to produce enough representative tumor tissue, an FFPE sample from archival tissue may be acceptable after approval of the sponsor.\r\nBone metastases, fine needle aspiration, brushing, cCell pellet from pleural effusion, or ascites or lavage are not acceptable.\r\nTwo additional tumour samples are needed: Archival tumor sample must be available for exploratory PD-L1 testing in archival tissue and archival or ""de novo"" tissue sample for biomarkers must also be available.\r\nPerformance status determined by Eastern Cooperative Oncology Group (ECOG) score of 0-1\r\nNormal organ and bone marrow function:\r\n\r\nHaemoglobin ≥10.0 g/dL\r\nAbsolute neutrophil count (ANC) ≥1.5 x 109/L\r\nLymphocyte count ≥0.5 × 109/L\r\nPlatelet count ≥100 x 109/L\r\nTotal bilirubin ≤1.5 x institutional upper limit of normal (ULN)\r\nSerum albumin ≥2.5 g/dL\r\nAspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 x ULN, unless liver metastases are present in which case they must be ≤5 x ULN\r\nSerum creatinine ≤1.5 x institutional ULN or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation\r\nPatients not receiving anticoagulant medication must have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN.\r\nNegative Test Results for Hepatitis.\r\nToxicities related to previous treatments must be recovered to < grade 2\r\nFemale participants must be postmenopausal or surgically sterile or otherwise have a negative serum pregnancy test within 7 days of the first study treatment and agree to abstain from heterosexual intercourse or use single or combined contraceptive methods.\r\nParticipant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.\r\nParticipant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.'}",{'Arm - Disease - Indication': 'Adult Recurrent Ovarian Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03598270,"{'Official Title': 'A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months', 'Brief Summary': 'Atezolizumab in this study is expected to have a positive benefit-risk profile for the treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest, atezolizumab is being investigated also in combination with platinum-based doublet chemotherapy in second line (2L)/ third line (3L) platinum-sensitive recurrent ovarian cancer patients in ATALANTE (NCT02891824), which also includes bevacizumab in the combination. The study is proceeding as expected after >100 patients enrolled and under independent Data Monitoring Committee (IDMC) supervision.\r\n\r\nPlatinum-containing therapy is considered the treatment of choice for patients with platinum-sensitive relapse. However the duration of response and the prolongation of the progression free interval with chemotherapy are usually brief, among other because these chemotherapy regimens cannot be continued until progression as they are associated with neurological, renal and hematological toxicity and cannot generally be tolerated for more than about 6 to 9 cycles.\r\n\r\nNiraparib received FDA approval in March 2017 as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Recently, the European Medicines Agency (EMA) has also approved niraparib as maintenance monotherapy. Despite the progress brought about by niraparib, there is a need for a more effective treatment to extend the progression free interval in this patient population. The combination with immune checkpoint inhibitors such as anti-death protein 1 (anti-PD1) or anti-death protein ligand 1 (anti-PD-L1) has a compelling rationale to this aim, especially under the light of the emerging clinical data of this combination.\r\n\r\nThe use of atezolizumab concurrent to platinum-containing chemotherapy followed by niraparib as maintenance therapy after completion of chemotherapy, as per normal clinical practice, may provide further benefit to patients in terms of prolonging the progression free interval and increasing the interval between lines of chemotherapy, hence delaying further hospitalization and the cumulative toxicities associated with chemotherapy. Additionally, preliminary studies with atezolizumab suggest an acceptable tolerability profile for long term clinical use in recurrent ovarian cancer patients and other indications.', 'Condition': 'Recurrent Ovarian Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients ≥ 18 years old\r\nLife expectancy ≥3 months\r\nSigned informed consent and ability to comply with treatment and follow-up\r\nHistologically confirmed diagnosis (cytology alone excluded) of high- grade serous or endometrioid ovarian, primary peritoneal or tubal carcinoma.\r\nBreast Cancer (BRCA) mutational status is known (germline or somatic)\r\nRelapsed disease more than 6 months after the last platinum dose\r\nNo more than 2 prior lines of chemotherapy are allowed, and the last one must contain a platinum-based regimen\r\nAt least one measurable lesion to assess response by RECIST v1.1 criteria.\r\nMandatory de novo tumor biopsy (collected within 3 months prior to randomization) sent to HistoGene X as a formalin-fixed, paraffin-embedded (FFPE) sample for PD-L1 status determination for randomization. The inclusion of patients with non informative tissue PD-L1 status will be capped to 10% of the whole study population:\r\n\r\nIf the mandatory de novo biopsy is technically not possible or failed to produce enough representative tumor tissue, an FFPE sample from archival tissue may be acceptable after approval of the sponsor.\r\nBone metastases, fine needle aspiration, brushing, cCell pellet from pleural effusion, or ascites or lavage are not acceptable.\r\nTwo additional tumour samples are needed: Archival tumor sample must be available for exploratory PD-L1 testing in archival tissue and archival or ""de novo"" tissue sample for biomarkers must also be available.\r\nPerformance status determined by Eastern Cooperative Oncology Group (ECOG) score of 0-1\r\nNormal organ and bone marrow function:\r\n\r\nHaemoglobin ≥10.0 g/dL\r\nAbsolute neutrophil count (ANC) ≥1.5 x 109/L\r\nLymphocyte count ≥0.5 × 109/L\r\nPlatelet count ≥100 x 109/L\r\nTotal bilirubin ≤1.5 x institutional upper limit of normal (ULN)\r\nSerum albumin ≥2.5 g/dL\r\nAspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 x ULN, unless liver metastases are present in which case they must be ≤5 x ULN\r\nSerum creatinine ≤1.5 x institutional ULN or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation\r\nPatients not receiving anticoagulant medication must have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN.\r\nNegative Test Results for Hepatitis.\r\nToxicities related to previous treatments must be recovered to < grade 2\r\nFemale participants must be postmenopausal or surgically sterile or otherwise have a negative serum pregnancy test within 7 days of the first study treatment and agree to abstain from heterosexual intercourse or use single or combined contraceptive methods.\r\nParticipant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.\r\nParticipant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.'}",{'Arm - Disease - Indication': 'Adult Recurrent Ovarian Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04571489,"{'Official Title': 'Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study', 'Brief Summary': 'This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.', 'Condition': 'Pancreatic Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed pancreatic cancer originating from pancreatic ductal epithelium, excluding pancreatic endocrine tumor;\r\nLocally advanced or metastatic pancreatic cancer in no condition for radical radiotherapy or operation;\r\nFailed in first-line gemcitabine or fluorouracil drugs chemotherapy (Recurrence within 6 months after treatment, progression or toxicity intolerance during treatment);\r\nChemotherapy, targeted therapy or radical radiotherapy should be stopped 3 weeks ago, immunotherapy should be stopped 4 weeks ago, and previous toxicity recovered (CTCAE ≤ level 1);\r\nMeasurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\r\nNo younger than 18 years old of either gender;\r\nEastern Cooperative Oncology Group (ECOG) performance status score 0-1;\r\nEstimated life expectancy >3 months;\r\nThe function of important organs meets the following requirements:\r\n\r\nabsolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 85×109/L, hemoglobin ≥ 90g/L;\r\nserum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min, U-pro < 2+ or 1.0g/L; if U-pro ≥2+ or 1.0g/L, 24 hours U-pro ≤ 1.0g/L can be included;\r\ntotal bilirubin ≤ 1.5×ULN, obstructive jaundice with biliary drainage: total bilirubin ≤ 2.0×ULN; alanine transaminase and aspartate aminotransferase ≤ 2.5×ULN, liver metastasis ≤ 5.0×ULN; serum albumin ≥ 30g/L;\r\nWithout a history of allergy or hypersensitivity to camptothecin drugs;\r\nTaking drugs orally;\r\nSerum human chorionic gonadotropin negative in premenopausal women; female patients of childbearing potential and male patients with female partners of childbearing potential must be willing to avoid pregnancy;\r\nAbility to understand the study and sign informed consent.\r\n'}",{'Arm - Disease - Indication': 'Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04571489,"{'Official Title': 'Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study', 'Brief Summary': 'This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.', 'Condition': 'Pancreatic Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed pancreatic cancer originating from pancreatic ductal epithelium, excluding pancreatic endocrine tumor;\r\nLocally advanced or metastatic pancreatic cancer in no condition for radical radiotherapy or operation;\r\nFailed in first-line gemcitabine or fluorouracil drugs chemotherapy (Recurrence within 6 months after treatment, progression or toxicity intolerance during treatment);\r\nChemotherapy, targeted therapy or radical radiotherapy should be stopped 3 weeks ago, immunotherapy should be stopped 4 weeks ago, and previous toxicity recovered (CTCAE ≤ level 1);\r\nMeasurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\r\nNo younger than 18 years old of either gender;\r\nEastern Cooperative Oncology Group (ECOG) performance status score 0-1;\r\nEstimated life expectancy >3 months;\r\nThe function of important organs meets the following requirements:\r\n\r\nabsolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 85×109/L, hemoglobin ≥ 90g/L;\r\nserum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min, U-pro < 2+ or 1.0g/L; if U-pro ≥2+ or 1.0g/L, 24 hours U-pro ≤ 1.0g/L can be included;\r\ntotal bilirubin ≤ 1.5×ULN, obstructive jaundice with biliary drainage: total bilirubin ≤ 2.0×ULN; alanine transaminase and aspartate aminotransferase ≤ 2.5×ULN, liver metastasis ≤ 5.0×ULN; serum albumin ≥ 30g/L;\r\nWithout a history of allergy or hypersensitivity to camptothecin drugs;\r\nTaking drugs orally;\r\nSerum human chorionic gonadotropin negative in premenopausal women; female patients of childbearing potential and male patients with female partners of childbearing potential must be willing to avoid pregnancy;\r\nAbility to understand the study and sign informed consent.\r\n'}",{'Arm - Disease - Indication': 'Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01946477,"{'Official Title': 'A Phase 2, Multicenter, Multi-cohort, Open-label Study of Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide Based Therapy in the First or Second Line Setting.', 'Brief Summary': 'This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy.\r\n\r\nThis trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide.\r\n\r\nThis trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide.\r\n\r\nThis trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of >60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.', 'Condition': 'Multiple Myeloma', 'Detailed Description': 'A phase 2, multicenter, multi-cohort, open-label study of pomalidomide in combination with low-dose dexamethasone or pomalidomide in combination with low-dose dexamethasone and daratumumab in subjects with relapsed or refractory multiple myeloma following lenalidomide based therapy in the first or second line setting.\r\n\r\nThis trial will assess, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Time to Response (TTR), Time to Progression(TTP) and safety.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSubjects must satisfy the following criteria to be enrolled in the study:\r\n\r\nAdults (age ≥ 18 years at the time of signing the ICD) with documented diagnosis of MM and measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours).\r\nSubjects enrolling in Cohort A (POM+LD-dex) must have received 2 prior treatment lines of anti-myeloma therapy. Subjects enrolling in Cohort B and Cohort C (POM+DARA+LD-dex) must have received 1 or 2 prior treatment lines of anti-myeloma therapy.\r\nAll subjects must have received prior treatment with LEN or a LEN-containing regimen for at least 2 consecutive cycles as the most recent treatment regimen.\r\nAll subjects must have documented disease progression during or after their last antimyeloma therapy.\r\nSubjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\r\nSubjects must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted.\r\nSubjects must be able to adhere to the study visit schedule and other protocol requirements.\r\nAll subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes.\r\nFemales with child-bearing potential (FCBP†) must agree to use 2 reliable forms of contraception* simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including during dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe. For subjects enrolled in Cohort B and Cohort C, pregnancy prevention and testing will continue until 3 months after last dose of daratumumab.\r\nFemales must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation. Female subjects enrolled in Cohort B and Cohort C must agree to abstain from breastfeeding and donating eggs during study participation and until 3 months after last dose of daratumumab.\r\nMales must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. Male subjects enrolled in Cohort B and Cohort C must agree to use a latex condom during any sexual contact with FCBP while participating in the study and until 3 months after last dose of daratumumab.\r\nMales must also agree to refrain from donating semen or sperm during the treatment phase and for 28 days after discontinuation from this study treatment. Male subjects enrolled in Cohort B and Cohort C must also agree to refrain from donating semen or sperm during the treatment phase and until 3 months after last dose of daratumumab.\r\nAll subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment.\r\nAll subjects must agree not to share medication.'}",{'Arm - Disease - Indication': 'Adult Relapsed or Refractory Previously Treated Multiple Myeloma Following Lenalidomide Based Therapy in the First or Second Line Setting'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01946477,"{'Official Title': 'A Phase 2, Multicenter, Multi-cohort, Open-label Study of Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide Based Therapy in the First or Second Line Setting.', 'Brief Summary': 'This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy.\r\n\r\nThis trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide.\r\n\r\nThis trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of > 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide.\r\n\r\nThis trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of >60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.', 'Condition': 'Multiple Myeloma', 'Detailed Description': 'A phase 2, multicenter, multi-cohort, open-label study of pomalidomide in combination with low-dose dexamethasone or pomalidomide in combination with low-dose dexamethasone and daratumumab in subjects with relapsed or refractory multiple myeloma following lenalidomide based therapy in the first or second line setting.\n\nThis trial will assess, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Time to Response (TTR), Time to Progression(TTP) and safety.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSubjects must satisfy the following criteria to be enrolled in the study:\r\n\r\nAdults (age ≥ 18 years at the time of signing the ICD) with documented diagnosis of MM and measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours).\r\nSubjects enrolling in Cohort A (POM+LD-dex) must have received 2 prior treatment lines of anti-myeloma therapy. Subjects enrolling in Cohort B and Cohort C (POM+DARA+LD-dex) must have received 1 or 2 prior treatment lines of anti-myeloma therapy.\r\nAll subjects must have received prior treatment with LEN or a LEN-containing regimen for at least 2 consecutive cycles as the most recent treatment regimen.\r\nAll subjects must have documented disease progression during or after their last antimyeloma therapy.\r\nSubjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\r\nSubjects must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted.\r\nSubjects must be able to adhere to the study visit schedule and other protocol requirements.\r\nAll subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes.\r\nFemales with child-bearing potential (FCBP†) must agree to use 2 reliable forms of contraception* simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including during dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe. For subjects enrolled in Cohort B and Cohort C, pregnancy prevention and testing will continue until 3 months after last dose of daratumumab.\r\nFemales must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation. Female subjects enrolled in Cohort B and Cohort C must agree to abstain from breastfeeding and donating eggs during study participation and until 3 months after last dose of daratumumab.\r\nMales must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. Male subjects enrolled in Cohort B and Cohort C must agree to use a latex condom during any sexual contact with FCBP while participating in the study and until 3 months after last dose of daratumumab.\r\nMales must also agree to refrain from donating semen or sperm during the treatment phase and for 28 days after discontinuation from this study treatment. Male subjects enrolled in Cohort B and Cohort C must also agree to refrain from donating semen or sperm during the treatment phase and until 3 months after last dose of daratumumab.\r\nAll subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment.\r\nAll subjects must agree not to share medication.'}",{'Arm - Disease - Indication': 'Adult Relapsed or Refractory Previously Treated Multiple Myeloma Following Lenalidomide Based Therapy in the First or Second Line Setting'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04204941,"{'Official Title': 'A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma\n', 'Brief Summary': 'The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue.\n\nPart 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study.\n\nPart 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse.\n\nThe study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma', 'Condition': 'Advanced Soft-tissue Sarcoma\nAdvanced Epithelioid Sarcoma', 'Detailed Description': 'The open-label phase 1b portion is designed to evaluate the safety of the combination of tazemetostat + doxorubicin, as well as to establish the maximum tolerated dose (MTD) and the RP3D. The phase 3 portion of the clinical trial aims to compare tazemetostat + doxorubicin to the current front-line standard treatment, single-agent doxorubicin + placebo, when used as first-line treatment in locally advanced unresectable or metastatic ES.', 'Inclusion Criteria': 'Inclusion Criteria\n\nParticipants must meet ALL the following inclusion criteria to be eligible to enroll in this study:\n\nHave voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol. Study related activities will not start until written consent is obtained.\nLife expectancy ≥ 3 months before enrollment\nPhase 1b: 18-65 years old histologically confirmed Soft Tissue Sarcoma\nPhase 3: ≥18 years old with unresectable locally advanced or metastatic Epithelioid Sarcoma and tumor tissue available\nHave measurable disease\nECOG performance status of 0, 1, or 2\nHave adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function as required per protocol\nFemales must not be lactating or pregnant at Screening or Baseline\nFemales must not be pregnant or breast feeding and agree to use highly effective contraception during the clinical trial and for 6 months following the final dose of study\nMale participants of child-bearing potential must have had either a successful vasectomy or practice highly effective contraception\nParticipants diagnosed with human immunodeficiency virus (HIV) are eligible to participate in the study if their infection is well controlled on anti-retroviral therapy'}",{'Arm - Disease - Indication': 'Frontline Unresectable Locally Advanced or Metastatic Epithelioid Sarcoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04204941,"{'Official Title': 'A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma\n', 'Brief Summary': 'The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue.\n\nPart 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study.\n\nPart 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse.\n\nThe study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma', 'Condition': 'Advanced Soft-tissue Sarcoma\nAdvanced Epithelioid Sarcoma', 'Detailed Description': 'The open-label phase 1b portion is designed to evaluate the safety of the combination of tazemetostat + doxorubicin, as well as to establish the maximum tolerated dose (MTD) and the RP3D. The phase 3 portion of the clinical trial aims to compare tazemetostat + doxorubicin to the current front-line standard treatment, single-agent doxorubicin + placebo, when used as first-line treatment in locally advanced unresectable or metastatic ES.', 'Inclusion Criteria': 'Inclusion Criteria\n\nParticipants must meet ALL the following inclusion criteria to be eligible to enroll in this study:\n\nHave voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol. Study related activities will not start until written consent is obtained.\nLife expectancy ≥ 3 months before enrollment\nPhase 1b: 18-65 years old histologically confirmed Soft Tissue Sarcoma\nPhase 3: ≥18 years old with unresectable locally advanced or metastatic Epithelioid Sarcoma and tumor tissue available\nHave measurable disease\nECOG performance status of 0, 1, or 2\nHave adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function as required per protocol\nFemales must not be lactating or pregnant at Screening or Baseline\nFemales must not be pregnant or breast feeding and agree to use highly effective contraception during the clinical trial and for 6 months following the final dose of study\nMale participants of child-bearing potential must have had either a successful vasectomy or practice highly effective contraception\nParticipants diagnosed with human immunodeficiency virus (HIV) are eligible to participate in the study if their infection is well controlled on anti-retroviral therapy'}",{'Arm - Disease - Indication': 'Frontline Unresectable Locally Advanced or Metastatic Epithelioid Sarcoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT02601950,"{'Official Title': 'A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma', 'Brief Summary': 'This study will include participants with various types of cancer known as soft-tissue sarcomas.\n\nTissues that can be affected by soft tissue sarcomas include fat, muscle, blood vessels, deep skin tissues, tendons and ligaments.\n\nSoft tissue cancers are rare and can occur almost anywhere in the body.\n\nPart 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin (current front line treatment) can be tolerated (known as tolerability).\n\nIt is also designed to establish a recommended study drug dosage for the next part of the study.\n\nPart 2 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo (dummy treatment).', 'Condition': 'Malignant Rhabdoid Tumors (MRT), Rhabdoid Tumors of the Kidney (RTK), Atypical Teratoid Rhabdoid Tumors (ATRT), Selected Tumors With Rhabdoid Features, Synovial Sarcoma, INI1-negative Tumors, Malignant Rhabdoid Tumor of Ovary, Renal Medullary Carcinoma, Epithelioid Sarcoma, Poorly Differentiated Chordoma (or Other Chordoma With Sponsor Approval), Any Solid Tumor With an EZH2 GOF Mutation', 'Detailed Description': ""This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID (twice daily) and 1600 mg QD (once daily). Subjects will be screened for eligibility within 21 days of the planned date of the first dose of tazemetostat and enrolled into one of 8 cohorts:\n\nCohort using tazemetostat 800 mg BID\n\nCohort 1 (Closed for enrollment): malignant rhabdoid tumor (MRT), rhabdoid tumor of the kidney (RTK), atypical teratoid rhabdoid tumor (ATRT), and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type (SCCOHT), also known as malignant rhaboid tumor of the ovary (MRTO)\nCohort 2 (Closed for enrollment): Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement\nCohort 3 (Closed for enrollment): Other integrase interactor 1 (INI1) negative tumors or any solid tumor with an enhancer of zeste homologue-2 (EZH2) gain of function (GOF) mutation, including: epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma) any solid tumor with an EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma\nCohort 4 (Closed for enrollment): Renal medullary carcinoma (RMC)\nCohort 5 (Closed for enrollment): Epithelioid sarcoma (ES)\nCohort 6 (Closed for enrollment): Epithelioid sarcoma (ES) undergoing mandatory tumor biopsy\nCohort 7 (Closed for enrollment): Poorly differentiated chordoma (or other chordoma with Sponsor approval)\nCohort using tazemetostat 1600 mg QD\n\n• Cohort 8 (Closed for enrollment): Epitheliod sarcoma\n\nParticipants will be dosed in continuous 28-day cycles. (Note: if treatment with study drug is discontinued prior to completing 2 years, subjects will be followed for a maximum duration of 2 years from start of study drug dosing.) Response assessment will be performed every 8 weeks while on study.\n\nTreatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study."", 'Inclusion Criteria': ""Inclusion Criteria:\n\nAge (at the time of consent/assent): ≥18 years of age\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\nHas provided signed written informed consent\nHas a life expectancy of >3 months\nHas a malignancy:\n\nFor which there are no standard therapies available (Cohorts 1, 3, 4 and 5)\nThat is relapsed or refractory after treatment with an approved therapy(ies), defined as metastatic or non-resectable, locally advanced disease that has previously been treated with and progressed following approved therapy(ies) (Cohort 2)\n\nThat has progressed within 6 months prior to study enrollment (Cohort 5 Expansion, Cohort 6 and Cohort 8 ONLY)\nHas a documented local diagnostic pathology of original biopsy confirmed by a Clinical Laboratory Improvement Amendments (CLIA/College of American Pathologists (CAP) or equivalent laboratory certification\nFor Cohort 1 (rhabdoid tumors only), the following test results must be available by local laboratory: morphology and immunophenotypic panel consistent with rhabdoid tumors, and loss of INI1 or SMARCA4 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation when INI1 or SMARCA4 IHC is equivocal or unavailable\nFor Cohort 2 (subjects with relapsed/refractory synovial sarcoma only), the following tests must be available by local laboratory: Morphology consistent with synovial sarcomas, and cytogenetics or fluorescence in situ hybridization (FISH) and/or molecular confirmation (e.g., DNA sequencing) of SS18 rearrangement t(X;18)(p11;q11)\nFor Cohort 3, 4, 5, 7 and 8 (subjects with INI1-negative/aberrant tumors or any solid tumor with EZH2 GOF mutation only), the following test results must be available by local laboratory: Morphology and immunophenotypic panel consistent with INI1-negative tumors (not applicable for solid tumors with EZH2 GOF mutation), and loss of INI1 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 loss or mutation when INI1 IHC is equivocal or unavailable, or molecular evidence of EZH2 GOF mutation\nFor Cohort 6 (subjects with ES undergoing optional tumor biopsy) only:\n\nMorphology and immunophenotypic panel consistent with ES (e.g., CD34, EMA, Keratin, and INI1)\nHas all prior treatment (i.e. chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ≤Grade 1 per CTCAE version 4.0.3 or are clinically stable and not clinically significant, at time of enrollment.\nPrior anti-cancer therapy(ies), if applicable, must be completed according to the criteria below:\n\nChemotherapy: cytotoxic (At least 14 days since last dose of chemotherapy prior to first dose of tazemetostat)\nChemotherapy: nitrosoureas (At least 6 weeks since last dose of nitrosoureas prior to first dose of tazemetostat)\nChemotherapy: non-cytotoxic (e.g., small molecule inhibitor) (At least 14 days since last dose of non-cytotoxic chemotherapy prior to first dose of tazemetostat)\nMonoclonal antibody(ies) (At least 28 days since the last dose of any monoclonal antibody prior to first dose of tazemetostat)\nImmunotherapy (e.g. tumor vaccine) (At least 42 days since last dose of immunotherapy agent(s) prior to first dose of tazemetostat)\nRadiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat/At least 21 days from stereostatic radiosurgery prior to first dose of tazemetostat/At least 12 weeks from craniospinal, ≥50% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)\nHigh dose therapy with autologous hematopoietic cell infusion (At least 60 days from last infusion prior to first dose of tazemetostat)\nHematopoietic growth factor (At least 14 days from last dose of hematopoietic growth factor prior to first dose of tazemetostat)\nHas sufficient tumor tissue (slides or blocks) available for central confirmatory testing\nHas measurable disease based on either RECIST 1.1 for solid tumors or RANO for CNS tumors\nHas adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function.\nFor subjects with CNS Tumors only, subject must have seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of 21 days prior to the planned first dose of tazemetostat\nHas a shortening fraction of >27% or an ejection fraction of ≥50% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan and New York Heart Association (NYHA) Class ≤2\nHas a QT interval corrected by Fridericia's formula (QTcF) ≤480 msec\nFemale subjects of childbearing potential must:\n\nHave a negative beta-human chorionic gonadotropin (β-hCG) pregnancy test at time of screening and within 14 days prior to planned first dose of tazemetostat and\nAgree to use effective contraception from a minimum of 7 days prior to first dose until 6 months following the last dose of tazemetostat and have a male partner who uses a condom, or\nPractice true abstinence or have a male partner who is vasectomized\nMale subjects with a female partner of childbearing potential must:\n\nBe vasectomized, or\nAgree to use condoms as defined in Section 8.6.2, from first dose of tazemetostat until 3 months following the last dose of tazemetostat, or\nHave a female partner who is NOT of childbearing potential""}",{'Arm - Disease - Indication': 'INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03092856,"{'Official Title': 'Phase II Randomized Double Blind Trial of PF-04518600, an OX40 Antibody, in Combination With Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients With Metastatic Renal Cell Carcinoma', 'Brief Summary': 'This randomized phase II trial studies how well axitinib with or without anti-OX40 antibody PF-04518600 work in treating patients with kidney cancer that has spread to other parts of the body. Biological therapies, such as anti-OX40 antibody PF-04518600, use substances made from living organisms that may may stimulate the immune system in different ways and stop tumor cells from growing. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib with or without anti-OX40 antibody PF-04518600 may work better in treating patients with kidney cancer.', 'Condition': 'Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Cancer, Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES:\n\nI. To determine whether a statistically significant improvement in progression free survival exists for patients receiving the combination.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether the combination is safe and whether objective response rate (ORR), duration of response (DOR) and overall survival (OS) improve as a result of treatment with combination of axitinib + anti-OX40 antibody PF-04518600 (PF-04518600 [OX40 Ab]) compared to axitinib + placebo.\n\nTERTIARY OBJECTIVES:\n\nI. To determine whether pre and post treatment specimens collected during the trial demonstrate significant changes in tumor microenvironment and enhanced immune response to tumor cells.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive axitinib orally (PO) twice daily (BID) on days 1-14 and anti-OX40 antibody PF-04518600 intravenously (IV) over 60 minutes on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive axitinib as in Arm I and placebo IV on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30, 90, and 180 days.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nWilling and able to provide informed consent\nHistological confirmation of renal cell carcinoma (RCC) with a predominantly (> 50%) clear cell component\nMetastatic RCC\nMust have had a nephrectomy (radical or partial) and must provide the cell block from the nephrectomy\nMeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria\nMust have progression of disease within 6 months of study enrollment after treatment with only one of the following:\n\nTwo prior lines of therapy: a VEGF inhibitor (other than axitinib), followed by a single agent PD-1/PDL-1 antibody, or\nOne prior line of therapy: combination of a VEGF inhibitor (other than axitinib) AND a PD1/PDL1 antibody, or\nAdditional prior systemic treatments not allowed\nMust agree to a fresh core or excisional biopsy from a metastatic site within a 12-week window prior to enrollment; if such a biopsy is already available, cell blocks must be provided; (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission); specimens from the nephrectomy and fresh biopsy must be received and assessed for adequacy of tissue by the Data Coordinating Center (DCC) (University of Southern California [USC]) prior to randomization\nZubrod performance status of =< 2\nWomen of childbearing potential must use method(s) of contraception; the individual methods of contraception should be determined in consultation with the treating physician or investigator\nWomen of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the administration of the investigational product; female patients who are not of childbearing potential as defined below, are eligible to be included (ie, meet at least one of the following criteria):\n\nHave undergone a documented hysterectomy and/or bilateral oophorectomy\nHave medically confirmed ovarian failure; or\nAchieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women\nWomen must not be breastfeeding\nMen who are sexually active with women of childbearing potential must use any contraceptive method with a failure rate of less than 1% per year\nContraception should be continued using two highly effective methods for a period of 90 days\nSerum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) using actual weight (ideal or adjusted weights are unacceptable)\nWhite blood cells (WBC) >= 2000/uL\nNeutrophils >= 1500/uL\nPlatelets >= 100x10^3/uL\nHemoglobin >= 9g/dL\nAspartate aminotransferase (AST) =< 3 x ULN\nAlanine aminotransferase (ALT) =< 3 x ULN\nBilirubin =< 1.5 x ULN\n""}",{'Arm - Disease - Indication': 'Metastatic Renal Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT03092856,"{'Official Title': 'Phase II Randomized Double Blind Trial of PF-04518600, an OX40 Antibody, in Combination With Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients With Metastatic Renal Cell Carcinoma', 'Brief Summary': 'This randomized phase II trial studies how well axitinib with or without anti-OX40 antibody PF-04518600 work in treating patients with kidney cancer that has spread to other parts of the body. Biological therapies, such as anti-OX40 antibody PF-04518600, use substances made from living organisms that may may stimulate the immune system in different ways and stop tumor cells from growing. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib with or without anti-OX40 antibody PF-04518600 may work better in treating patients with kidney cancer.', 'Condition': 'Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Cancer, Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES:\n\nI. To determine whether a statistically significant improvement in progression free survival exists for patients receiving the combination.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether the combination is safe and whether objective response rate (ORR), duration of response (DOR) and overall survival (OS) improve as a result of treatment with combination of axitinib + anti-OX40 antibody PF-04518600 (PF-04518600 [OX40 Ab]) compared to axitinib + placebo.\n\nTERTIARY OBJECTIVES:\n\nI. To determine whether pre and post treatment specimens collected during the trial demonstrate significant changes in tumor microenvironment and enhanced immune response to tumor cells.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive axitinib orally (PO) twice daily (BID) on days 1-14 and anti-OX40 antibody PF-04518600 intravenously (IV) over 60 minutes on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive axitinib as in Arm I and placebo IV on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30, 90, and 180 days.', 'Inclusion Criteria': ""Inclusion Criteria:\n\nWilling and able to provide informed consent\nHistological confirmation of renal cell carcinoma (RCC) with a predominantly (> 50%) clear cell component\nMetastatic RCC\nMust have had a nephrectomy (radical or partial) and must provide the cell block from the nephrectomy\nMeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria\nMust have progression of disease within 6 months of study enrollment after treatment with only one of the following:\n\nTwo prior lines of therapy: a VEGF inhibitor (other than axitinib), followed by a single agent PD-1/PDL-1 antibody, or\nOne prior line of therapy: combination of a VEGF inhibitor (other than axitinib) AND a PD1/PDL1 antibody, or\nAdditional prior systemic treatments not allowed\nMust agree to a fresh core or excisional biopsy from a metastatic site within a 12-week window prior to enrollment; if such a biopsy is already available, cell blocks must be provided; (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission); specimens from the nephrectomy and fresh biopsy must be received and assessed for adequacy of tissue by the Data Coordinating Center (DCC) (University of Southern California [USC]) prior to randomization\nZubrod performance status of =< 2\nWomen of childbearing potential must use method(s) of contraception; the individual methods of contraception should be determined in consultation with the treating physician or investigator\nWomen of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the administration of the investigational product; female patients who are not of childbearing potential as defined below, are eligible to be included (ie, meet at least one of the following criteria):\n\nHave undergone a documented hysterectomy and/or bilateral oophorectomy\nHave medically confirmed ovarian failure; or\nAchieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women\nWomen must not be breastfeeding\nMen who are sexually active with women of childbearing potential must use any contraceptive method with a failure rate of less than 1% per year\nContraception should be continued using two highly effective methods for a period of 90 days\nSerum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) using actual weight (ideal or adjusted weights are unacceptable)\nWhite blood cells (WBC) >= 2000/uL\nNeutrophils >= 1500/uL\nPlatelets >= 100x10^3/uL\nHemoglobin >= 9g/dL\nAspartate aminotransferase (AST) =< 3 x ULN\nAlanine aminotransferase (ALT) =< 3 x ULN\nBilirubin =< 1.5 x ULN\n""}",{'Arm - Disease - Indication': 'Metastatic Renal Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01927744,"{'Official Title': 'Randomized, Placebo-Controlled, Phase 2 Study Of Induction Chemotherapy With Cisplatin/Carboplatin, And Docetaxel With Or Without Erlotinib In Patients With Head And Neck Squamous Cell Carcinomas Amenable For Surgical Resection\n', 'Brief Summary': 'The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied.\n\nIn this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.\n\nThis is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN.\n\nUp to 100 patients will take part in this study. All will be enrolled at MD Anderson.', 'Condition': 'Head and Neck Cancer\n', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nSuspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study.\nPatients must have surgically resectable disease, in the opinion of the treating physician\nAge ≥ 18 years.\nECOG PS ≤ 2 (Appendix C)\nAdequate bone marrow, hepatic and renal function defined by: 6. ANC ≥ 1.5 x 109/L;\n7. Platelet count ≥ 100 x 109/L;\n\n8. ALT (SGPT) ≤ 1.5 x upper limit of normal (ULN);\n\n9. Total bilirubin ≤ ULN (patient's with Gilbert's syndrome are eligible, even if total bilirubin is > ULN);\n\n10. Alkaline phosphatase ≤ 2.5 x ULN;\n\n11. Serum creatinine ≤ 1.5 x ULN.\n\n12. Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy. Female patients of childbearing potential must provide a negative pregnancy test (serum or urine) ≤ 14 days prior to treatment initiation.\n\n13. Written informed consent to participate in the study according to the investigational review board (IRB).""}",{'Arm - Disease - Indication': 'Resectable Stage III or Stage IVA or Stage IVB Head and Neck Squamous Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT01927744,"{'Official Title': 'Randomized, Placebo-Controlled, Phase 2 Study Of Induction Chemotherapy With Cisplatin/Carboplatin, And Docetaxel With Or Without Erlotinib In Patients With Head And Neck Squamous Cell Carcinomas Amenable For Surgical Resection\n', 'Brief Summary': 'The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied.\n\nIn this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.\n\nThis is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN.\n\nUp to 100 patients will take part in this study. All will be enrolled at MD Anderson.', 'Condition': 'Head and Neck Cancer\n', 'Detailed Description': '-', 'Inclusion Criteria': ""Inclusion Criteria:\n\nSuspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study.\nPatients must have surgically resectable disease, in the opinion of the treating physician\nAge ≥ 18 years.\nECOG PS ≤ 2 (Appendix C)\nAdequate bone marrow, hepatic and renal function defined by: 6. ANC ≥ 1.5 x 109/L;\n7. Platelet count ≥ 100 x 109/L;\n\n8. ALT (SGPT) ≤ 1.5 x upper limit of normal (ULN);\n\n9. Total bilirubin ≤ ULN (patient's with Gilbert's syndrome are eligible, even if total bilirubin is > ULN);\n\n10. Alkaline phosphatase ≤ 2.5 x ULN;\n\n11. Serum creatinine ≤ 1.5 x ULN.\n\n12. Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy. Female patients of childbearing potential must provide a negative pregnancy test (serum or urine) ≤ 14 days prior to treatment initiation.\n\n13. Written informed consent to participate in the study according to the investigational review board (IRB).""}",{'Arm - Disease - Indication': 'Resectable Stage III or Stage IVA or Stage IVB Head and Neck Squamous Cell Carcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04194203,"{'Official Title': 'A Phase III, Randomized, Double-Blind Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151)\n', 'Brief Summary': ""This study will evaluate the efficacy and safety of atezolizumab when given in combination with bevacizumab, investigator's choice of either paclitaxel or pemetrexed, and carboplatin compared with placebo given in combination with bevacizumab, paclitaxel or pemetrexed, and carboplatin in patients with chemotherapy-naive, Stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC). The study will be conducted in two phases: Induction Phase and Maintenance Phase.\n"", 'Condition': 'Carcinoma, Non-Small-Cell Lung\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically or cytologically confirmed Stage IV non-squamous NSCLC\nNo prior treatment for Stage IV non-squamous NSCLC, with the following exceptions: (1) Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or were intolerant to treatment with one or more EGFR TKIs, such as erlotinib, gefitinib, afatinib, dacomitinib, and osimertinib, or another EGFR TKI appropriate for the treatment of EGFR-mutant NSCLC. Patients who have progressed on or were intolerant to first-line osimertinib or other third-generation EGFR TKIs are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, such as erlotinib, gefitinib, afatinib, dacomitinib, and who have no evidence of the EGFR T790M mutation in the tumor tissue after TKI therapy are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation in their tumor tissue must have also progressed on or were intolerant to osimertinib to be eligible. (2) Patients with an ALK gene rearrangement must have experienced disease progression or were intolerant to treatment with one or more ALK inhibitors, such as crizotinib, alectinib, ceritinib, brigatinib, ensartinib and lorlatinib that are appropriate for the treatment of NSCLC that has an ALK gene rearrangement.\nAvailability of a representative tumor specimen that is suitable for the determination of PD-L1 status, as well as the presence of EGFR mutations and ALK gene rearrangements, via central testing.\nTreatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy treatment for patients who have received prior neoadjuvant and/or adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease\nMeasurable disease, as defined by RECIST v1.1\nEastern Cooperative Oncology Group Performance Status of 0 or 1\nLife expectancy >=3 months\nAdequate hematologic and end-organ function\nNegative HIV test at screening\nNegative hepatitis B surface antigen (HBsAg) test at screening\nNegative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening\nNegative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs\nFor men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm'}",{'Arm - Disease - Indication': 'Chemotherapy-Naïve Stage IV Non-Squamous Non-Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04194203,"{'Official Title': 'A Phase III, Randomized, Double-Blind Study of Bevacizumab, Carboplatin, and Paclitaxel or Pemetrexed With or Without Atezolizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer (IMpower151)\n', 'Brief Summary': ""This study will evaluate the efficacy and safety of atezolizumab when given in combination with bevacizumab, investigator's choice of either paclitaxel or pemetrexed, and carboplatin compared with placebo given in combination with bevacizumab, paclitaxel or pemetrexed, and carboplatin in patients with chemotherapy-naive, Stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC). The study will be conducted in two phases: Induction Phase and Maintenance Phase.\n"", 'Condition': 'Carcinoma, Non-Small-Cell Lung\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically or cytologically confirmed Stage IV non-squamous NSCLC\nNo prior treatment for Stage IV non-squamous NSCLC, with the following exceptions: (1) Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or were intolerant to treatment with one or more EGFR TKIs, such as erlotinib, gefitinib, afatinib, dacomitinib, and osimertinib, or another EGFR TKI appropriate for the treatment of EGFR-mutant NSCLC. Patients who have progressed on or were intolerant to first-line osimertinib or other third-generation EGFR TKIs are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, such as erlotinib, gefitinib, afatinib, dacomitinib, and who have no evidence of the EGFR T790M mutation in the tumor tissue after TKI therapy are eligible. Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation in their tumor tissue must have also progressed on or were intolerant to osimertinib to be eligible. (2) Patients with an ALK gene rearrangement must have experienced disease progression or were intolerant to treatment with one or more ALK inhibitors, such as crizotinib, alectinib, ceritinib, brigatinib, ensartinib and lorlatinib that are appropriate for the treatment of NSCLC that has an ALK gene rearrangement.\nAvailability of a representative tumor specimen that is suitable for the determination of PD-L1 status, as well as the presence of EGFR mutations and ALK gene rearrangements, via central testing.\nTreatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy treatment for patients who have received prior neoadjuvant and/or adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease\nMeasurable disease, as defined by RECIST v1.1\nEastern Cooperative Oncology Group Performance Status of 0 or 1\nLife expectancy >=3 months\nAdequate hematologic and end-organ function\nNegative HIV test at screening\nNegative hepatitis B surface antigen (HBsAg) test at screening\nNegative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening\nNegative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs\nFor men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm'}",{'Arm - Disease - Indication': 'Chemotherapy-Naïve Stage IV Non-Squamous Non-Small Cell Lung Cancer'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04674956,"{'Official Title': 'A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine Versus Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer', 'Brief Summary': 'Aim：Evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.\r\n\r\nDrug information：\r\n\r\nanti-PD1 antibody (Camrelizumab)\r\nAG regimens：the standard first-line regimens for metastatic pancreatic cancer.', 'Condition': 'Pancreatic Cancer Stage IV, Pancreatic Cancer Metastatic', 'Detailed Description': ""CPOG1210-07 is a prospective, randomized, double-blinded, multi-center clinical trial in China aiming to evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine versus Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.\n\nThe anti-PD1 antibody(Camrelizumab) is a humanized monoclonal antibody which can specifically bind to PD-1 and block the interaction between PD-1 and its ligand (PD-L1), allowing T cells to recover the immune response against tumors. It is proved to be effective in certain cancers such as ovarian cancers and certification proved by Chinese Food and Drug Administration(CFDA) includes Hodgkin's lymphoma, non-small cell lung cancer, esophageal cancer and liver cancer."", 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n1. Aged >= 18 years, male or female; 2. Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma; 3. Patients have never received systematical anti-cancer therapy; 4. Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion which has never received local treatment like radiotherapy(The lesion located in previous radiotherapy areas can also be selected as target lesions if the progress confirmed.) 5. ECOG:0-1; 6. Expected survival>=12 weeks; 7. Essential organs function must meet the following criteria (Any blood products, growth factor, leucocyte promoting drugs, platelet promoting drugs, drugs for anemia are not allowed in 14 days before the first use of the experimental medication):\r\n\r\nAbsolute neutrophil count(ANC) >= 1.5x10^9/L\r\nPlatelet >= 85x10^9/L\r\nHemoglobin >= 90g/L\r\nSerum Albumin >= 30g/L\r\nTotal bilirubin <= 2.0 ULN (Biliary obstructive patients after biliary drainage <= 2.5 ULN), AST and ALT <= 3.0 ULN (patients with liver metastasis <= 5 ULN);\r\nCreatinine clearance rate >60 mL/min;\r\nActivated Partial Thromboplastin Time and International Standardized Ratio <= 1.5 ULN (Patients using stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin and INR is within the expected range of anticoagulants can be selected.)'}",{'Arm - Disease - Indication': 'First-Line Metastatic Pancreatic Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT04674956,"{'Official Title': 'A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine Versus Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer', 'Brief Summary': 'Aim：Evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.\r\n\r\nDrug information：\r\n\r\nanti-PD1 antibody (Camrelizumab)\r\nAG regimens：the standard first-line regimens for metastatic pancreatic cancer.', 'Condition': 'Pancreatic Cancer Stage IV, Pancreatic Cancer Metastatic', 'Detailed Description': ""CPOG1210-07 is a prospective, randomized, double-blinded, multi-center clinical trial in China aiming to evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine versus Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.\r\n\r\nThe anti-PD1 antibody(Camrelizumab) is a humanized monoclonal antibody which can specifically bind to PD-1 and block the interaction between PD-1 and its ligand (PD-L1), allowing T cells to recover the immune response against tumors. It is proved to be effective in certain cancers such as ovarian cancers and certification proved by Chinese Food and Drug Administration(CFDA) includes Hodgkin's lymphoma, non-small cell lung cancer, esophageal cancer and liver cancer."", 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n1. Aged >= 18 years, male or female; 2. Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma; 3. Patients have never received systematical anti-cancer therapy; 4. Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion which has never received local treatment like radiotherapy(The lesion located in previous radiotherapy areas can also be selected as target lesions if the progress confirmed.) 5. ECOG:0-1; 6. Expected survival>=12 weeks; 7. Essential organs function must meet the following criteria (Any blood products, growth factor, leucocyte promoting drugs, platelet promoting drugs, drugs for anemia are not allowed in 14 days before the first use of the experimental medication):\r\n\r\nAbsolute neutrophil count(ANC) >= 1.5x10^9/L\r\nPlatelet >= 85x10^9/L\r\nHemoglobin >= 90g/L\r\nSerum Albumin >= 30g/L\r\nTotal bilirubin <= 2.0 ULN (Biliary obstructive patients after biliary drainage <= 2.5 ULN), AST and ALT <= 3.0 ULN (patients with liver metastasis <= 5 ULN);\r\nCreatinine clearance rate >60 mL/min;\r\nActivated Partial Thromboplastin Time and International Standardized Ratio <= 1.5 ULN (Patients using stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin and INR is within the expected range of anticoagulants can be selected.)'}",{'Arm - Disease - Indication': 'First-Line Metastatic Pancreatic Adenocarcinoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05640830,"{'Official Title': 'A Phase 1B/2 Study of Trastuzumab, Bevacizumab With Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy (TREAZURE)\n', 'Brief Summary': 'This is a multicenter, open-label, prospective, phase 2 study of trastuzumab, bevacizumab, and paclitaxel as second-line treatment for patients with HER2-positive advanced gastric cancer who had progressed on first-line chemotherapy including trastuzumab or anti-HER2 agents.\n', 'Condition': 'HER2-positive Advanced Gastric Cancer\n', 'Detailed Description': 'Trastuzumab has been administered at 6 mg/kg every 3 weeks after initial loading of 8 mg/kg during the first anticancer treatment, so in the second anticancer treatment, 4 mg/kg is administered every 2 weeks to maintain the same concentration. Bevacizumab is administered at 5 mg/kg at 2-weekly intervals used in metastatic colorectal cancer. Paclitaxel is administered on a standard schedule of 80 mg/m2 for 3 consecutive weeks followed by a 1-week break as an existing weekly regimen, and when side effects occur, the weekly dose is reduced by 25% to 60 mg/m2 for 3 weeks or administered every 2 weeks. Administer 80 mg/m2. Administration of this drug is set as one cycle of 4 weeks.\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHER2-positive advanced gastric cancer\n\nDefined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratory tests. (SISH positivity is defined as the ratio of the HER2 gene copy number to the CEP17 signal ≥ 2.0)\nor significant overexpression of HER2 protein on target proteomic analysis (multiple reaction monitoring)\nPatients who have progressed in response to one systemic anticancer therapy for advanced gastric cancer\nPatients who are willing and able to write a written consent form for this trial.\nPatients aged 19 years or older at the time of signing the subject consent form.\nPatients with measurable or evaluable lesions according to RECIST 1.1.\nECOG activity status 0, 1 or 2\nas patients with adequate organ function\n\nAbsolute neutrophil (ANC) ≥1.0 x 109/L, platelet ≥100 x 109/L, hemoglobin ≥9 g/dL, serum creatinine ≤1.5 x ULN, total bilirubin ≤3.0 mg on laboratory tests within 2 weeks before starting treatment /dL, AST/ALT ≤5 x ULN\nEchocardiogram EF ≥55% or MUGA scan ≥50%'}",{'Arm - Disease - Indication': 'HER2-Positive Advanced Gastric Cancer\n\n'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05121350,"{'Official Title': 'A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma\n', 'Brief Summary': 'A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma\n', 'Condition': 'Soft Tissue Sarcoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nEastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\nLife expectancy >=3 months.\nFemale patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.\nUnderstood and signed an informed consent form.'}",{'Arm - Disease - Indication': 'First-Line Advanced Soft Tissue Sarcoma'},0 "Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on ""arms data"" to identify the indication. The ""arms data"" may be incomplete or irrelevant. You should not make assumptions about the ""arms data"" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer ",NCT05121350,"{'Official Title': 'A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma\n', 'Brief Summary': 'A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma\n', 'Condition': 'Soft Tissue Sarcoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nEastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\nLife expectancy >=3 months.\nFemale patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.\nUnderstood and signed an informed consent form.'}",{'Arm - Disease - Indication': 'First-Line Advanced Soft Tissue Sarcoma'},0