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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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}

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'}