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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

NCT05052801

{'Official Title': 'A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression', 'Brief Summary': 'The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)', 'Condition': 'Gastric Cancer\nGastroesophageal Junction Adenocarcinoma', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\n\nAdults with histologically documented unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy\nFibroblast growth factor receptor 2b (FGFR2b) ≥10% 2+/3+ tumor cell staining as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy\nEastern Cooperative Oncology Group (ECOG) less than or equal to 1\nMeasurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) V 1.1\nParticipant has no contraindications to mFOLFOX6 chemotherapy\nAdequate organ and bone marrow function:\n\nabsolute neutrophil count greater than or equal to 1.5 times 10^9/L\nplatelet count greater than or equal to 100 times 10^9/L\nhemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment\naspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement). Total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease)\ncalculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age]) × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female)\ninternational normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment"}

{'Arm - Disease - Indication': 'Previously Untreated FGFR2b Overexpressed Adult Unresectable Advanced Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02891824

{'Official Title': 'A Randomized, Double-blinded, Phase III Study of Atezolizumab Versus Placebo in Patients With Late Relapse of Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated by Platinum-based Chemotherapy and Bevacizumab', 'Brief Summary': 'This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months).', 'Condition': 'Ovarian Cancer', 'Detailed Description': 'Approximately 600 patients will be randomized using an Interactive Voice Response System /Interactive web system (IVR/IWR system) in a 1:2 ratio to the treatments as specified below:\r\n\r\nA. Arm A: Placebo + bevacizumab & platinum-based chemotherapy.\r\n\r\nThe placebo arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)\r\n\r\nCarboplatin (day1)combined with gemcitabine (day1 & day8) and bevacizumab (day1) + placebo ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab ( day1) + placebo (day1) q3weeks until disease progression or\r\nCarboplatin (d1) combined with paclitaxel (day1) and bevacizumab (day1) + placebo (d1) x 6 cycles every 3weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression or\r\nCarboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 & 15) + placebo ( day1& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression.\r\nB. Arm B: Atezolizumab + bevacizumab & platinum-based chemotherapy\r\n\r\nThe atezolizumab arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)\r\n\r\nCarboplatin (day1) combined with gemcitabine (day1 & d8) and bevacizumab (day1) + atezolizumab ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab (day1) + atezolizumab (day1) q3w until disease progression or\r\nCarboplatin (day1) combined with paclitaxel (day1) and bevacizumab ( day1) + atezolizumab (1200mg, d1) x 6 cycles every 3wk (day1) q3weeks until disease progression or\r\nCarboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 & 15) + atezolizumab (day1& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + atezolizumab ( day1) q3weeks until disease progression.\r\nBefore randomization to the study:\r\n\r\nA tumor biopsy should have been obtained and sent to the central laboratory\r\nPD-L1 status should be determined', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nFemale Patients must be ≥18 years of age.\r\nSigned informed consent and ability to comply with treatment and follow-up.\r\nPatients with histologically confirmed progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma\r\nPatients with PD-L1 status determined for stratification on mandatory de novo biopsy sent to central laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample.\r\n\r\nCell pellet from pleural effusion, or ascites or lavage are not acceptable.\r\nFor core needle biopsy specimens, at least three cores should be obtained. Biopsies must be obtained in a manner that minimizes risks. If the location of the tumor renders tumor biopsy medically unsafe or not feasible, patient eligibility should be discussed with the sponsor.\r\nPatients whose disease has relapsed more than 6 months from the last dose of platinum before randomization:\r\n\r\ncriterion for relapse can be according to RECIST v1.1, CA-125 (GCIG) or clinical symptoms\r\nthe interval between last dose of platinum and entry in the study should be free of new anti-cancer treatment, with the exception of a maintenance therapy which is allowed up to 21 days before study entry.\r\nPatients with one or 2 prior lines of chemotherapy. The last line of chemotherapy should have included platinum.\r\nAvailability at the study site of representative FFPE tumor sample from surgery during front line therapy, at best before chemotherapy\r\nPatients must have normal organ and bone marrow function :\r\n\r\nHaemoglobin ≥ 10.0 g/dL.\r\nAbsolute neutrophil count (ANC) ≥ 1.5 x 109/L.\r\nPlatelet count ≥ 100 x 109/L.\r\nTotal bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).\r\nAspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.\r\nSerum creatinine ≤ 1.5 x institutional ULN,\r\nPatients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at the time of randomization.\r\nUrine dipstick for proteinuria < 2+. If urine dipstick is ≥2+, 24-hours urine must demonstrate ≤1 g of protein in 24 hours.\r\nNormal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).\r\nEastern Cooperative Oncology Group (ECOG) performance status 0-1\r\nFor France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category'}

{'Arm - Disease - Indication': 'Platinum Sensitive Late Relapsed Non Mucinous Epithelial Ovarian or Primary Peritoneal/Fallopian Tube Adenocarcinoma Treated With Chemotherapy Plus Bevacizumab'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02891824

{'Official Title': 'A Randomized, Double-blinded, Phase III Study of Atezolizumab Versus Placebo in Patients With Late Relapse of Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated by Platinum-based Chemotherapy and Bevacizumab', 'Brief Summary': 'This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months).', 'Condition': 'Ovarian Cancer', 'Detailed Description': 'Approximately 600 patients will be randomized using an Interactive Voice Response System /Interactive web system (IVR/IWR system) in a 1:2 ratio to the treatments as specified below:\r\n\r\nA. Arm A: Placebo + bevacizumab & platinum-based chemotherapy.\r\n\r\nThe placebo arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)\r\n\r\nCarboplatin (day1)combined with gemcitabine (day1 & day8) and bevacizumab (day1) + placebo ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab ( day1) + placebo (day1) q3weeks until disease progression or\r\nCarboplatin (d1) combined with paclitaxel (day1) and bevacizumab (day1) + placebo (d1) x 6 cycles every 3weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression or\r\nCarboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 & 15) + placebo ( day1& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression.\r\nB. Arm B: Atezolizumab + bevacizumab & platinum-based chemotherapy\r\n\r\nThe atezolizumab arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)\r\n\r\nCarboplatin (day1) combined with gemcitabine (day1 & d8) and bevacizumab (day1) + atezolizumab ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab (day1) + atezolizumab (day1) q3w until disease progression or\r\nCarboplatin (day1) combined with paclitaxel (day1) and bevacizumab ( day1) + atezolizumab (1200mg, d1) x 6 cycles every 3wk (day1) q3weeks until disease progression or\r\nCarboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 & 15) + atezolizumab (day1& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + atezolizumab ( day1) q3weeks until disease progression.\r\nBefore randomization to the study:\r\n\r\nA tumor biopsy should have been obtained and sent to the central laboratory\r\nPD-L1 status should be determined', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nFemale Patients must be ≥18 years of age.\r\nSigned informed consent and ability to comply with treatment and follow-up.\r\nPatients with histologically confirmed progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma\r\nPatients with PD-L1 status determined for stratification on mandatory de novo biopsy sent to central laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample.\r\n\r\nCell pellet from pleural effusion, or ascites or lavage are not acceptable.\r\nFor core needle biopsy specimens, at least three cores should be obtained. Biopsies must be obtained in a manner that minimizes risks. If the location of the tumor renders tumor biopsy medically unsafe or not feasible, patient eligibility should be discussed with the sponsor.\r\nPatients whose disease has relapsed more than 6 months from the last dose of platinum before randomization:\r\n\r\ncriterion for relapse can be according to RECIST v1.1, CA-125 (GCIG) or clinical symptoms\r\nthe interval between last dose of platinum and entry in the study should be free of new anti-cancer treatment, with the exception of a maintenance therapy which is allowed up to 21 days before study entry.\r\nPatients with one or 2 prior lines of chemotherapy. The last line of chemotherapy should have included platinum.\r\nAvailability at the study site of representative FFPE tumor sample from surgery during front line therapy, at best before chemotherapy\r\nPatients must have normal organ and bone marrow function :\r\n\r\nHaemoglobin ≥ 10.0 g/dL.\r\nAbsolute neutrophil count (ANC) ≥ 1.5 x 109/L.\r\nPlatelet count ≥ 100 x 109/L.\r\nTotal bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).\r\nAspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.\r\nSerum creatinine ≤ 1.5 x institutional ULN,\r\nPatients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at the time of randomization.\r\nUrine dipstick for proteinuria < 2+. If urine dipstick is ≥2+, 24-hours urine must demonstrate ≤1 g of protein in 24 hours.\r\nNormal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).\r\nEastern Cooperative Oncology Group (ECOG) performance status 0-1\r\nFor France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category'}

{'Arm - Disease - Indication': 'Platinum Sensitive Late Relapsed Non Mucinous Epithelial Ovarian or Primary Peritoneal/Fallopian Tube Adenocarcinoma Treated With Chemotherapy Plus Bevacizumab'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05029102

{'Official Title': 'TAS-102 Combined With Anlotinib in Patients With Metastatic Gastric Cancer Refractory to Standard Treatments (THALIA): a Prospective Single-arm Phase II Study', 'Brief Summary': 'To determine the efficacy and safety of TAS-102 and Anlotinib in patients with metastatic gastric cancer who had been treated with ≥ 2 lines of prior standard chemotherapy', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAge ≥ 18 years, ≤75 years\r\nHistologically confirmed gastric cancer with distant metastasis\r\nECOG 0-1\r\nProgression on ≥ 2 lines of prior standard chemotherapy\r\nPatients can swallow pills normally\r\nExpected overall survival ≥6 months\r\nBlood routine: no blood transfusion or blood products usage within 14 days, G-CSF or other hematopoietic stimulator was not used. WBC counts > 3000/µl，Absolute neutrophil count (ANC) ≥ 1500 cells/µl，Platelet count ≥ 100,000/µl，Hemoglobin ≥ 9.0 g/dL.\r\nAST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN\r\nProthrombin time (PT), international standard ratio (INR) ≤1.5 × ULN\r\nWomen of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment;\r\nInformed consent has been signed.'}

{'Arm - Disease - Indication': 'Previously Treated Refractory Metastatic Gastric 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

NCT05481463

{'Official Title': 'A Open-label, Single-arm, Single-center, Phase II Clinical Study of Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer', 'Brief Summary': 'This is a single-center, single-arm, open-label, phase 2 clinical study, to explore the efficacy and safety of surufatinib combined with TAS-102 in third-line and later-line therapy of patients with advanced pancreatic cancer', 'Condition': 'Pancreatic Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nInformed consent has been signed\r\nHistologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic cancer\r\nAge ≥ 18 years, ≤75 years, male or female\r\nECOG PS：0-1, expected overall survival ≥12 months\r\nPatients who have previously received at least two systemic therapies for locally advanced or metastatic pancreatic cancer; patients with BRCA1/2 germline mutations have previously received platinum-containing regimens\r\nPatients must have at least one measurable liver metastases (RECIST 1.1)\r\nNo serious organic diseases of the heart, lungs, brain and other organs\r\nPatients must have adequate organ and bone marrow function\r\nWomen of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration'}

{'Arm - Disease - Indication': 'Third-Line and Later-Line Unresectable 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

NCT05672316

{'Official Title': 'A Phase I/II Trial of Botensilimab, Balstilimab and Regorafenib (BBR) in Patients With Microsatellite Stable (MSS) Metastatic Colorectal Cancer Who Progressed on Prior Chemotherapy', 'Brief Summary': "This phase I/II trial tests how well botensilimab, balstilimab, and regorafenib works in treating patients with microsatellite stable colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who have progressed on prior chemotherapy. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Regorafenib binds to and inhibits growth factor receptors, which may inhibit the growth of new blood vessels that tumors need to grow. Giving botensilimab, balstilimab, and regorafenib in combination may work better in treating patients with metastatic colorectal cancer than giving these drugs alone.", 'Condition': 'Advanced Colorectal Adenocarcinoma\nAdvanced Microsatellite Stable Colorectal Carcinoma\nMetastatic Colorectal Adenocarcinoma\nMetastatic Microsatellite Stable Colorectal Carcinoma\nStage III Colorectal Cancer AJCC v8\nStage IV Colorectal Cancer AJCC v8', 'Detailed Description': 'PRIMARY OBJECTIVES:\n\nI. To identify the recommended phase 2 dose (RP2D) of botensilimab, balstilimab, and regorafenib (BBR) in patients with chemotherapy-resistant microsatellite stable (MSS) metastatic colorectal cancer (MSS mCRC). (Phase I) II. To estimate the overall response rate (ORR) of botensilimab, balstilimab, and regorafenib in patients with chemotherapy-resistant MSS mCRC, with and without liver metastatic disease. (Phase II)\n\nSECONDARY OBJECTIVES:\n\nI. Describe the safety of botensilimab, balstilimab, and regorafenib at all evaluable dose levels. (Phase I) II. Describe the efficacy of BBR in terms of ORR, progression free survival (PFS) and overall survival (OS). (Phase I) III. To evaluate the safety/feasibility of botensilimab, balstilimab, and regorafenib through the assessment of adverse events. (Phase II) IV. Estimate the PFS, OS and duration of response (DOR). (Phase II)\n\nCORRELATIVE OBJECTIVES:\n\nI. Evaluate potential circulating biomarkers of response, resistance, activity, and toxicity. (Phase I/II) II. Correlate baseline molecular biomarkers (RAS, BRAF, TMB, and PD-L1 if available), with overall outcome. (Phase I/II)\n\nOUTLINE: This is a phase I, dose-escalation study of botensilimab followed by a phase II study.\n\nPatients receive botensilimab intravenously (IV), balstilimab IV, and regorafenib orally (PO) on study. Patients also undergo computed tomography (CT) and collection of blood throughout the study.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nDocumented informed consent of the participant and/or legally authorized representative.\n\nAssent, when appropriate, will be obtained per institutional guidelines\nAge: >= 18 years\nEastern Cooperative Oncology Group (ECOG) =< 1\nLife expectancy >= 3 months\nAble to swallow and absorb oral tablets\nHistological or cytological confirmed advanced, metastatic, or progressive proficient mismatch repair (pMMR)/MSS adenocarcinoma of colon or rectum\n\nMicrosatellite status should be performed per local standard of practice (e.g., immunohistochemistry [IHC] and/or polymerase chain reaction [PCR], or next-generation sequencing). Only participants with pMMR/MSS mCRC are eligible\nPatients should have measurable metastatic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines\nKnown extended RAS and BRAF status as per local standard of practice. TMB and PD-L1 status will be collected when available but not mandated for enrollment\nPatients must have progressed following exposure to all of the following agents:\n\nFluoropyrimidines (capecitabine or 5-FU)\nIrinotecan\nOxaliplatin\nAnti-EGFR therapy if RAS and BRAF wild type with left colon primary\nPatients must have evidence of progression on or after the last treatment received and within 6 months prior to study enrollment\n\nPatients who were intolerant to prior systemic chemotherapy regimens are eligible if there is documented evidence of clinically significant intolerance despite adequate supportive measures\nAdjuvant/neoadjuvant chemotherapy can be considered as one line of chemotherapy for advanced/metastatic disease if the participant had disease recurrence within 6 months of completion\nFor patients with liver metastatic disease, patients must have no more than 5 hepatic metastases at the time of enrollment\nPatients without liver metastatic disease should be either with no history of liver metastatic disease or with history of resected or ablated liver metastases without evidence of disease recurrence in the liver for at least 6 months before enrollment\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAspartate aminotransferase (AST) =< 2.5 x ULN, unless presence of liver metastases for which =< 5 x ULN is allowed (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAlanine aminotransferase (ALT) =< 2.5 x ULN, unless presence of liver metastases for which =< 5 x ULN is allowed (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nSerum creatinine =< 1.5 x ULN or creatinine clearance >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nWhite blood cell (WBC) >= 2000/ul (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nHemoglobin >= 9 g/dl (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAbsolute neutrophil count (ANC) >= 1500/ul (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nPlatelets >= 75,000/mm^3 (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAlbumin >= 3.0 g/dl (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nWomen of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 7 days prior to day 1 of protocol therapy unless otherwise stated)\nAgreement by females and males of childbearing potential to use an effective method of birth control or abstain from sexual activity for the course of the study through at least 120 days after the last dose of protocol therapy\n\nFemales of non-childbearing potential defined as:\n\n>= 50 years of age and has not had menses for greater than 1 year\nAmenorrheic for >= 2 years without a hysterectomy and bilateral oophorectomy and a follicle stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation\nStatus is post-hysterectomy, bilateral oophorectomy, or tubal ligation'}

{'Arm - Disease - Indication': 'Advanced Metastatic Progressive Microsatellite Stable Colorectal Adenocarcinoma '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02257736

{'Official Title': 'A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)', 'Brief Summary': 'The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': "This is a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know the treatment) placebo-controlled and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to determine if participants with chemotherapy-naive mCRPC will benefit from the addition of apalutamide to AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment phase, and Follow-up phase. At the final analysis, the study will be unblinded. After the Independent Data Monitoring Committee (IDMC) review and the sponsor's subsequent decision participants will be offered to receive treatment either in the Open-Label Extension Phase or the Long-Term Extension Phase of study. Participants' safety will be monitored throughout the study.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nAdenocarcinoma of the prostate\nMetastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter\nCastration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)\nParticipants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period\nProstate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2\nParticipants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.'}

{'Arm - Disease - Indication': 'Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02257736

{'Official Title': 'A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)', 'Brief Summary': 'The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).', 'Condition': 'Prostatic Neoplasms', 'Detailed Description': "This is a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know the treatment) placebo-controlled and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to determine if participants with chemotherapy-naive mCRPC will benefit from the addition of apalutamide to AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment phase, and Follow-up phase. At the final analysis, the study will be unblinded. After the Independent Data Monitoring Committee (IDMC) review and the sponsor's subsequent decision participants will be offered to receive treatment either in the Open-Label Extension Phase or the Long-Term Extension Phase of study. Participants' safety will be monitored throughout the study.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nAdenocarcinoma of the prostate\nMetastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter\nCastration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)\nParticipants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period\nProstate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2\nParticipants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.'}

{'Arm - Disease - Indication': 'Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05353257

{'Official Title': 'A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer', 'Brief Summary': 'This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.', 'Condition': 'Limited-Stage Small Cell Lung Cancer', 'Detailed Description': 'Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.\r\n\r\nArm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale or female, aged ≥18 years when signing the ICF.\r\nHistologically diagnosed with SCLC.\r\nDiagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.\r\nMajor organs are functioning well.'}

{'Arm - Disease - Indication': 'Limited Stage Stage I to Stage III Small-Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05353257

{'Official Title': 'A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer', 'Brief Summary': 'This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.', 'Condition': 'Limited-Stage Small Cell Lung Cancer', 'Detailed Description': 'Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.\r\n\r\nArm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale or female, aged ≥18 years when signing the ICF.\r\nHistologically diagnosed with SCLC.\r\nDiagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.\r\nMajor organs are functioning well.'}

{'Arm - Disease - Indication': 'Limited Stage Stage I to Stage III Small-Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05328908

{'Official Title': 'A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer', 'Brief Summary': 'The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.', 'Condition': 'Colorectal Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry\r\nParticipants must have:\r\n\r\nprogressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;\r\nbeen intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures\r\nMust have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements\r\nMust have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately'}

{'Arm - Disease - Indication': 'Non Microsatellite Instability High / Deficient Mismatch Repair Previously Treated Metastatic Colorectal Cancer Progressive During At Least 1 But Not More Than 4 Prior Lines of Therapies'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05328908

{'Official Title': 'A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer', 'Brief Summary': 'The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.', 'Condition': 'Colorectal Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry\r\nParticipants must have:\r\n\r\nprogressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type), if available in the respective country, or;\r\nbeen intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures\r\nMust have sufficient tumor tissue & evaluable PD-L1 expression to meet the study requirements\r\nMust have measurable disease per RECIST v1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately'}

{'Arm - Disease - Indication': 'Non Microsatellite Instability High / Deficient Mismatch Repair Previously Treated Metastatic Colorectal Cancer Progressive During At Least 1 But Not More Than 4 Prior Lines of Therapies'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03959293

{'Official Title': 'A Randomized Phase II Study Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma', 'Brief Summary': 'Gastric adenocarcinoma is the 4th most frequent cancer and the 2nd leading cause of cancer mortality. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone).\n\nSecond-line chemotherapy-based treatment improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012).\n\nBased on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. The present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Condition': 'Gastric Adenocarcinoma\nGastric Cancer', 'Detailed Description': 'Gastric adenocarcinoma is the fourth most frequent cancer and the second leading cause of cancer mortality. Advanced gastric adenocarcinoma has a poor prognosis with short overall survival (ranging from 10% to 15% at 5-years) even after surgical complete resection and despite the progress in therapeutic approaches. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone). First-line chemotherapy depends on HER2 status, which also influenced overall survival (14 months for HER2 positive versus 10 months for HER2 negative tumors). In HER2 negative tumors standard first-line regimen is a doublet of fluoropyrimidine (5-fluorouracil or capecitabine) plus a platinum salt (cisplatin or oxaliplatin). 5-fluorouracil (5-FU) and capecitabine as also cisplatin and oxaliplatin have similar efficacy but different toxicities.\n\nIn patients whose tumor overexpresses the HER2 receptor adding trastuzumab to fluoropyrimidine/cisplatin regimen increased overall survival compared to chemotherapy alone. In HER2 negative tumors the addition of docetaxel to cisplatin/fluoropyrimidine regimen increased overall survival but its use remains limited in clinical practice because of its high toxicity. Preliminary results demonstrated a high efficacy with less toxicities of docetaxel-oxaliplatin-fluoropyrimidine combination, also called TFOX/FLOT regimen. Indeed, in France a large phase III trial comparing TFOX versus FOLFOX in first-line treatment of patients with advanced gastric or gastro-oesophageal junction adenocarcinoma is ongoing (GASTFOX, trial NCT03006432). Primary endpoint is progression-free survival (PFS) and 506 patients are planned between 2017 and 2020 (actually at the date of January 30, 2018, 65 patients are included).\n\nSecond-line chemotherapy improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Weekly paclitaxel monotherapy is also used because of its good efficacy-toxicity ratio. Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012). Recently ramucirumab monotherapy demonstrated its efficacy on overall survival in a randomized, placebo-controlled second-line metastatic study. In a randomized phase 3 trial ramucirumab also showed its efficacy in combination with paclitaxel versus paclitaxel monotherapy with a median overall survival of 9.6 versus 7.4 months, respectively (p=0.017; HR=0.81). However, the "amelioration du service medical rendu" (ASMR) assessed by the French "Haute Autorité de Santé" (HAS) consider an insufficient benefit to a reimbursement of ramucirumab in France. The HAS gave a moderate ASMR opinion (ASMR IV).\n\nDocetaxel is more and more frequently used in first-line chemotherapy then in this setting taxane (alone or combined with others drugs) cannot be used as second-line regimen. Indeed, based on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nHuman tumors tend to activate the immune system regulatory checkpoints as a means of escaping immunosurveillance. For instance, interaction between PD1 (Program Death 1) and PD-L1 (Program Death 1 ligand) will lead the activated T cell to a state of anergy. PD-L1 is up regulated on a wide range of cancers. Anti-PD1 and anti-PD-L1 monoclonal antibodies (mAbs), called immune checkpoint inhibitors (ICIs), have consequently been designed to restore T cell activity. Others ICIs are investigated, notably cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors. CTLA-4 transmits an inhibitory signal to T cells to prevent early excessive T cell activation. CTLA4 blockade may stimulate a more robust antitumor response by sustaining activation and proliferation of T lymphocytes and may overcome immune suppression mediated by regulatory T cells. ICIs have been recently tested in many cancers with promising results, especially in tumors with microsatellite instability (MSI) and/or PD-L1 overexpression.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. Finally, immunogenic cell death induced by chemotherapy may enhance efficacy of ICIs. Durvalumab (MEDI4736) is a human monoclonal antibody directed against PD-L1 in development for the treatment of many cancers. A phase I study included 16 patients with advanced gastric cancer and the objective response rate was 25%. Tremelimumab is a fully human monoclonal antibody against CTLA-4. Durvalumab plus tremelimumab combination showed a manageable tolerability profile, with antitumour activity irrespective of PD-L1 status in non-small cell lung cancer (NSCLC). Durvalumab alone or combined with tremelimumab is evaluated in phase III studies in NSCLC (e.g NEPTUNE and MYSTIC), small cell lung cancer (CASPIAN), hepatocellular carcinoma (HIMALAYA), bladder cancer (DANUBE) and head and neck cancer (EAGLE and KESTREL).\n\nConcerning safety of anti-PD1 plus anti-CTLA4 combination, in the randomized phase I/II CheckMate-032 study, that included 160 patients, there was no unexpected toxicity signal. Grade 3 and 4 treatment-related adverse events were 17%, 47%, and 27%, respectively. These rates of grade 3 and 4 treatment-related adverse events are those usually found with the anti-PD1 plus anti-CTLA4 combination in other tumors, observed approximately in 40% of patients. Up until now, there is no published data concerning combination of ICIs plus irinotecan. Nevertheless, in all trial combining chemotherapy plus anti-PD1 and/or anti-CTLA4 chemotherapy drugs were used at full-dose (5FU, oxaliplatin, cisplatin…). An Italian trial just started and combined full-dose FOLFOXIRI (5-FU 3200 mg/m2 plus irinotecan 165 mg/m2 and oxaliplatin 85 mg/m2) with bevacizumab (5 mg/kg) and atezolizumab (anti-PD-L1, 840 mg) in metastatic colorectal cancers as first-line treatment. FOLFOXIRI is a triplet chemotherapy more "toxic" than FOLFIRI doublet chemotherapy and this trial is a randomized phase II (FOLFOXIRI plus bevacizumab and atezolizumab versus FOLFOXIRI plus bevacizumab). There is, however, a preliminary safety phase in 6 patients, once they have all received at least 2 cycles of treatment, the latter being administered at full dose (AtezoTRIBE trial, NCT03721653).\n\nThe present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥ 18 years.\nBody weight > 30kg.\nHistologically proven advanced-stage unresectable adenocarcinoma of the stomach or the GEJ (Siewert II or III).\nKnown MSS/MSI status or tumor tissue available (frozen or paraffin-embedded, primary tumors or metastases) in order to allow determination of MSS/MSI status. The investigator needs to ensure that tumor tissues will be sent after patient randomization.\nFailure to platinium-based 1st line therapy with or without trastuzumab, or early recurrent disease after surgery with neo-adjuvant and/or adjuvant platinium-based chemotherapy (within 6 months of the end of chemotherapy) or progression during neo-adjuvant and/or adjuvant platinium-based chemotherapy.\nEligible for a second-line treatment with irinotecan and 5-FU.\nMeasurable or non-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\nEastern Cooperative Oncology Group (ECOG) performance status 0-1.\nAdequate organ function: ANC ≥ 1.5 x 109/L, haemoglobin ≥ 9 g/dL, platelets ≥ 100 x 109/L, AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), GGT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), bilirubin ≤ 1.5 x ULN, creatinin clearance > 40 mL/min (MDRD).\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.\nMan and woman who childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.\nPatient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.'}

{'Arm - Disease - Indication': 'Advanced Unresectable Gastric or Gastro-oesophageal Junction Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03959293

{'Official Title': 'A Randomized Phase II Study Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma\n', 'Brief Summary': 'Gastric adenocarcinoma is the 4th most frequent cancer and the 2nd leading cause of cancer mortality. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone).\n\nSecond-line chemotherapy-based treatment improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012).\n\nBased on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. The present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Condition': 'Gastric Adenocarcinoma\nGastric Cancer', 'Detailed Description': 'Gastric adenocarcinoma is the fourth most frequent cancer and the second leading cause of cancer mortality. Advanced gastric adenocarcinoma has a poor prognosis with short overall survival (ranging from 10% to 15% at 5-years) even after surgical complete resection and despite the progress in therapeutic approaches. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone). First-line chemotherapy depends on HER2 status, which also influenced overall survival (14 months for HER2 positive versus 10 months for HER2 negative tumors). In HER2 negative tumors standard first-line regimen is a doublet of fluoropyrimidine (5-fluorouracil or capecitabine) plus a platinum salt (cisplatin or oxaliplatin). 5-fluorouracil (5-FU) and capecitabine as also cisplatin and oxaliplatin have similar efficacy but different toxicities.\n\nIn patients whose tumor overexpresses the HER2 receptor adding trastuzumab to fluoropyrimidine/cisplatin regimen increased overall survival compared to chemotherapy alone. In HER2 negative tumors the addition of docetaxel to cisplatin/fluoropyrimidine regimen increased overall survival but its use remains limited in clinical practice because of its high toxicity. Preliminary results demonstrated a high efficacy with less toxicities of docetaxel-oxaliplatin-fluoropyrimidine combination, also called TFOX/FLOT regimen. Indeed, in France a large phase III trial comparing TFOX versus FOLFOX in first-line treatment of patients with advanced gastric or gastro-oesophageal junction adenocarcinoma is ongoing (GASTFOX, trial NCT03006432). Primary endpoint is progression-free survival (PFS) and 506 patients are planned between 2017 and 2020 (actually at the date of January 30, 2018, 65 patients are included).\n\nSecond-line chemotherapy improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Weekly paclitaxel monotherapy is also used because of its good efficacy-toxicity ratio. Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012). Recently ramucirumab monotherapy demonstrated its efficacy on overall survival in a randomized, placebo-controlled second-line metastatic study. In a randomized phase 3 trial ramucirumab also showed its efficacy in combination with paclitaxel versus paclitaxel monotherapy with a median overall survival of 9.6 versus 7.4 months, respectively (p=0.017; HR=0.81). However, the "amelioration du service medical rendu" (ASMR) assessed by the French "Haute Autorité de Santé" (HAS) consider an insufficient benefit to a reimbursement of ramucirumab in France. The HAS gave a moderate ASMR opinion (ASMR IV).\n\nDocetaxel is more and more frequently used in first-line chemotherapy then in this setting taxane (alone or combined with others drugs) cannot be used as second-line regimen. Indeed, based on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.\n\nHuman tumors tend to activate the immune system regulatory checkpoints as a means of escaping immunosurveillance. For instance, interaction between PD1 (Program Death 1) and PD-L1 (Program Death 1 ligand) will lead the activated T cell to a state of anergy. PD-L1 is up regulated on a wide range of cancers. Anti-PD1 and anti-PD-L1 monoclonal antibodies (mAbs), called immune checkpoint inhibitors (ICIs), have consequently been designed to restore T cell activity. Others ICIs are investigated, notably cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors. CTLA-4 transmits an inhibitory signal to T cells to prevent early excessive T cell activation. CTLA4 blockade may stimulate a more robust antitumor response by sustaining activation and proliferation of T lymphocytes and may overcome immune suppression mediated by regulatory T cells. ICIs have been recently tested in many cancers with promising results, especially in tumors with microsatellite instability (MSI) and/or PD-L1 overexpression.\n\nPreliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.\n\nOthers anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. Finally, immunogenic cell death induced by chemotherapy may enhance efficacy of ICIs. Durvalumab (MEDI4736) is a human monoclonal antibody directed against PD-L1 in development for the treatment of many cancers. A phase I study included 16 patients with advanced gastric cancer and the objective response rate was 25%. Tremelimumab is a fully human monoclonal antibody against CTLA-4. Durvalumab plus tremelimumab combination showed a manageable tolerability profile, with antitumour activity irrespective of PD-L1 status in non-small cell lung cancer (NSCLC). Durvalumab alone or combined with tremelimumab is evaluated in phase III studies in NSCLC (e.g NEPTUNE and MYSTIC), small cell lung cancer (CASPIAN), hepatocellular carcinoma (HIMALAYA), bladder cancer (DANUBE) and head and neck cancer (EAGLE and KESTREL).\n\nConcerning safety of anti-PD1 plus anti-CTLA4 combination, in the randomized phase I/II CheckMate-032 study, that included 160 patients, there was no unexpected toxicity signal. Grade 3 and 4 treatment-related adverse events were 17%, 47%, and 27%, respectively. These rates of grade 3 and 4 treatment-related adverse events are those usually found with the anti-PD1 plus anti-CTLA4 combination in other tumors, observed approximately in 40% of patients. Up until now, there is no published data concerning combination of ICIs plus irinotecan. Nevertheless, in all trial combining chemotherapy plus anti-PD1 and/or anti-CTLA4 chemotherapy drugs were used at full-dose (5FU, oxaliplatin, cisplatin…). An Italian trial just started and combined full-dose FOLFOXIRI (5-FU 3200 mg/m2 plus irinotecan 165 mg/m2 and oxaliplatin 85 mg/m2) with bevacizumab (5 mg/kg) and atezolizumab (anti-PD-L1, 840 mg) in metastatic colorectal cancers as first-line treatment. FOLFOXIRI is a triplet chemotherapy more "toxic" than FOLFIRI doublet chemotherapy and this trial is a randomized phase II (FOLFOXIRI plus bevacizumab and atezolizumab versus FOLFOXIRI plus bevacizumab). There is, however, a preliminary safety phase in 6 patients, once they have all received at least 2 cycles of treatment, the latter being administered at full dose (AtezoTRIBE trial, NCT03721653).\n\nThe present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥ 18 years.\nBody weight > 30kg.\nHistologically proven advanced-stage unresectable adenocarcinoma of the stomach or the GEJ (Siewert II or III).\nKnown MSS/MSI status or tumor tissue available (frozen or paraffin-embedded, primary tumors or metastases) in order to allow determination of MSS/MSI status. The investigator needs to ensure that tumor tissues will be sent after patient randomization.\nFailure to platinium-based 1st line therapy with or without trastuzumab, or early recurrent disease after surgery with neo-adjuvant and/or adjuvant platinium-based chemotherapy (within 6 months of the end of chemotherapy) or progression during neo-adjuvant and/or adjuvant platinium-based chemotherapy.\nEligible for a second-line treatment with irinotecan and 5-FU.\nMeasurable or non-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\nEastern Cooperative Oncology Group (ECOG) performance status 0-1.\nAdequate organ function: ANC ≥ 1.5 x 109/L, haemoglobin ≥ 9 g/dL, platelets ≥ 100 x 109/L, AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), GGT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), bilirubin ≤ 1.5 x ULN, creatinin clearance > 40 mL/min (MDRD).\nEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.\nMan and woman who childbearing potential agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake.\nPatient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed.'}

{'Arm - Disease - Indication': 'Advanced Unresectable Gastric or Gastro-oesophageal Junction Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03863483

{'Official Title': 'A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy', 'Brief Summary': 'This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.', 'Condition': 'Nonsquamous Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVolunteer to participate in clinical research; fully understand and know the research and sign informed consent;\r\nAge ≥ 18 years old and ≤ 75 years old, either sex;\r\nEastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;\r\nHas a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;\r\nHave at least one measurable lesion as defined by RECIST 1.1;\r\nHas progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;\r\nPatients without activating EGFR mutation;\r\nNormal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present;\r\nNormal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );\r\nNormal hematological function: absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];\r\nHas a life expectancy of at ≥3 months.'}

{'Arm - Disease - Indication': 'Second-Line Wild-Type EGFR Stage IV Nonsquamous Non-small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03863483

{'Official Title': 'A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy', 'Brief Summary': 'This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.', 'Condition': 'Nonsquamous Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nVolunteer to participate in clinical research; fully understand and know the research and sign informed consent;\r\nAge ≥ 18 years old and ≤ 75 years old, either sex;\r\nEastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;\r\nHas a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;\r\nHave at least one measurable lesion as defined by RECIST 1.1;\r\nHas progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;\r\nPatients without activating EGFR mutation;\r\nNormal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present;\r\nNormal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );\r\nNormal hematological function: absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];\r\nHas a life expectancy of at ≥3 months.'}

{'Arm - Disease - Indication': 'Second-Line Wild-Type EGFR Stage IV Nonsquamous Non-small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05179239

{'Official Title': 'A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ≥ 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}

{'Arm - Disease - Indication': 'First-Line Persistent, Recurrent, or Metastatic Cervical Adenosquamous Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05179239

{'Official Title': 'A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ≥ 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}

{'Arm - Disease - Indication': 'First-Line Persistent, Recurrent, or Metastatic Cervical Adenosquamous Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05179239

{'Official Title': 'A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer', 'Brief Summary': 'The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAged 18-70 years, female.\nWith Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.\nWith a life expectancy of ≥ 12 weeks.\nAcute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).\nWith at least one measurable lesion as per RECIST v1.1.\nWith histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.\nPersistent, recurrent, or metastatic cervical cancer.\nPatients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).\nWomen of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.\nPatients must agree and have signed the informed consent form.'}

{'Arm - Disease - Indication': 'First-Line Persistent, Recurrent, or Metastatic Cervical Adenosquamous Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04732494

{'Official Title': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma', 'Brief Summary': 'A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.', 'Condition': 'Esophageal Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.\nHave PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.\nHave measurable disease as assessed by RECIST v1.1.\nHave confirmed PD-L1 TAP ≥ 10% in tumor tissues tested by the central lab.\nEastern Cooperative Oncology Group Performance Status score of 0 or 1.'}

{'Arm - Disease - Indication': 'Second-Line Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04732494

{'Official Title': 'A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma', 'Brief Summary': 'A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.', 'Condition': 'Esophageal Squamous Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.\nHave PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.\nHave measurable disease as assessed by RECIST v1.1.\nHave confirmed PD-L1 TAP ≥ 10% in tumor tissues tested by the central lab.\nEastern Cooperative Oncology Group Performance Status score of 0 or 1.'}

{'Arm - Disease - Indication': 'Second-Line Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05299255

{'Official Title': 'An Open, Single-center Phase II Clinical Study of Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer', 'Brief Summary': 'SCLC has a very high degree of malignancy, and 60% to 70% of patients are diagnosed as extensive stage. The median survival of patients with limited-stage disease is about 15-20 months, and the median OS of patients with extensive-stage disease is about 8-13 months, and the 2-year and 5-year survival rates are about 5% and 1-2%, respectively. However, although the initial treatment has a high effective rate, most patients relapse or progress within 1 year, and the effect of re-treatment is poor and the prognosis is poor. The effective rate of SCLC second-line treatment is only 10-25%, and the median survival time is less than 6 months. After the third and fourth lines, there are almost no recognized treatment options. Therefore, improving the second-line treatment of SCLC has always been a difficult clinical problem, and new drugs are urgently needed to be explored. In small cell lung cancer, based on phase II clinical trials, paclitaxel is currently recommended by NCCN guidelines for subsequent systemic therapy in patients who relapse 6 months or less after initial therapy. Utidelone (UTD1) is an epothilone derivative with a similar mechanism of action to taxanes, but a completely different molecular structure.', 'Condition': 'SCLC, Extensive Stage', 'Detailed Description': 'Compared with paclitaxel, epothilones has higher water solubility and toxicity tolerance, and fewer side effects, these findings suggest that utidron may have better antitumor activity against small cell lung cancer. Therefore, to prospectively observe the treatment of extensive-stage small cell lung cancer with failure of second-line or above chemotherapy and receive Utilidron, so as to understand the efficacy, safety and tolerability of Utilidron in the third-line and above treatment of small cell lung cancer, which is a small Post-line treatment of cell lung cancer provides new directions and treatment options.\n\nThis study is an open, single-center phase II clinical study. Small cell lung cancer patients with disease progression or recurrence after second-line therapy or above, receive Utilidron injection. Utilidron injection 40mg/m2/d d1-5 q3w was administered until disease progression (PD), intolerable toxicity, initiation of new antitumor therapy, loss to follow-up, death, and the investigator decided to be tested Subjects who withdraw from the study treatment or the subject/their legal representative requests to withdraw from the study (whichever occurs first). After consultation with the sponsor, the patient will determine whether the treatment can be continued, observe and evaluate the preliminary efficacy and safety.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistologically diagnosed small cell lung cancer (except for small cell lung cancer mixed with other pathological types);\nThe expected survival period is not less than 3 months;\nSecond-line therapy (excluding maintenance therapy) and above with disease progression or recurrence of small cell lung cancer;\nPatients who have not received chemotherapy, radiotherapy, surgery, targeted therapy and immunotherapy within 4 weeks before enrollment;\nAge 18-75 years old, physical condition score ECOG 0-1 points;\nAt least one target lesion measurable by imaging within 3 weeks before enrollment, ordinary CT scan ≥ 20 mm, spiral CT scan diameter ≥ 10 mm (lymph node short diameter ≥ 15 mm);\nAsymptomatic brain metastases, or patients with stable disease for more than 4 weeks after brain metastases treatment;\nNeurological lesions should be less than grade 2 within 4 weeks before enrollment (NCI CTC4.03);\nRoutine blood and blood biochemical tests were basically normal within 1 week before enrollment (based on the normal value of the research center laboratory, no blood transfusion within 14 days before screening, and no rhG-CSF was used):\nBlood routine: HGB≥9g/dL; ANC≥1.5×109/L; PLT≥80×109/L; Blood biochemistry (without ALB infusion within 14 days): bilirubin <1.5 times the upper limit of normal, ALT and AST ≤2.5 times the upper limit of normal (if liver metastases exist, bilirubin ≤3 times the upper limit of normal, ALT and AST≤3 times the upper limit of normal) 5 times the upper limit of normal), serum Cr≤1.5 times the upper limit of normal or endogenous creatinine clearance ≥45 mL/min (Cockcroft-Gault formula);\n\nThose who have no major organ dysfunction and no concomitant heart disease;\nFemales of childbearing age, including those who are in menopause but have not reached postmenopausal state (natural amenorrhea for 12 consecutive months) and who have not received sterilization and ovarian and/or hysterectomy, must have a blood pregnancy test within 7 days before the first'}

{'Arm - Disease - Indication': 'Third-Line or Above Treatment of Recurrent Small cell lung cancer (except for small cell lung cancer mixed with other pathological types)'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04269200

{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)\n', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n', 'Condition': 'Endometrial Neoplasms\n', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer\n\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}

{'Arm - Disease - Indication': 'Newly Diagnosed Advanced or Recurrent Endometrial Neoplasm'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04269200

{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)\n', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n', 'Condition': 'Endometrial Neoplasms\n', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer\n\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}

{'Arm - Disease - Indication': 'Newly Diagnosed Advanced or Recurrent Endometrial Neoplasm'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04269200

{'Official Title': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)\n', 'Brief Summary': 'A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n', 'Condition': 'Endometrial Neoplasms\n', 'Detailed Description': 'This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.\n\nTarget patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer\n\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nAge ≥18 years at the time of screening and female.\nHistologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\nPatient must have endometrial cancer in one of the following categories:\n\nNewly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),\nNewly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)\nRecurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.\nNaïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse\nFPPE tumor sample must be available for MMR evaluation.\nHas Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.'}

{'Arm - Disease - Indication': 'Newly Diagnosed Advanced or Recurrent Endometrial Neoplasm'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04916613

{'Official Title': 'A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents', 'Brief Summary': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.', 'Condition': 'Prostate Cancer Metastatic', 'Detailed Description': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 patients who will be randomized (1:1) to receive either: (i) Experimental arm: ADT + darolutamide 600 mg po bid, or (ii) Control arm: ADT + placebo po bid. Response to treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (Scher, 2016). Treatment will be continued until radiographic disease progression. Treatment may also be terminated at the initiative of either the patient or the investigator for any reason that would be beneficial to the patient, including: unacceptable toxicity, intercurrent conditions that preclude continuation of treatment, or patient request. Following treatment discontinuation patients will enter the follow-up period and will be monitored for up to 10 years with regards to survival status, subsequent antineoplastic treatments and the status of ongoing adverse events (AEs) and/or new investigational product related AEs.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSigned a written informed consent form prior to any trial specific procedures.\r\nMen with histologically or cytologically confirmed adenocarcinoma of the prostate.\r\nAged ≥18 years old at the time of signing informed consent.\r\nDe novo metastatic disease defined by clinical or radiological evidence of metastases.\r\n\r\nNote: For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\r\n\r\nAt least one extra-pelvic lymph node ≥2 cm\r\nAt least one extra-pelvic lymph node ≥1 cm if the patients also have at least one pelvic lymph node ≥2 cm\r\nMeasurable disease or bone lesions that are evaluable according to PCWG3 criteria.\r\nIneligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:\r\n\r\nActivities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4/5;\r\n4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4;\r\nA Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire;\r\nBody mass index (BMI) ≤21 kg/m² and/or >10% weight loss in the last 6 months;\r\nTimed up and go test (TUG) >14 sec.\r\nAdequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L and platelets ≥80 x10⁹/L.\r\nAdequate liver function: alanine aminotransferase (ALT) <2 x upper limit of normal (ULN) and bilirubin <1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). For patients with documented liver metastasis, ALT <5 x ULN is acceptable.\r\nAdequate renal function: calculated creatinine clearance >30 ml/min (using the Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology Collaboration [CKD EPI) method).\r\nFor sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment.\r\nAffiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\r\nWilling and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.'}

{'Arm - Disease - Indication': 'Metastatic Castration-Naive Prostate Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04916613

{'Official Title': 'A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents', 'Brief Summary': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.', 'Condition': 'Prostate Cancer Metastatic', 'Detailed Description': 'This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 patients who will be randomized (1:1) to receive either: (i) Experimental arm: ADT + darolutamide 600 mg po bid, or (ii) Control arm: ADT + placebo po bid. Response to treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (Scher, 2016). Treatment will be continued until radiographic disease progression. Treatment may also be terminated at the initiative of either the patient or the investigator for any reason that would be beneficial to the patient, including: unacceptable toxicity, intercurrent conditions that preclude continuation of treatment, or patient request. Following treatment discontinuation patients will enter the follow-up period and will be monitored for up to 10 years with regards to survival status, subsequent antineoplastic treatments and the status of ongoing adverse events (AEs) and/or new investigational product related AEs.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSigned a written informed consent form prior to any trial specific procedures.\r\nMen with histologically or cytologically confirmed adenocarcinoma of the prostate.\r\nAged ≥18 years old at the time of signing informed consent.\r\nDe novo metastatic disease defined by clinical or radiological evidence of metastases.\r\n\r\nNote: For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\r\n\r\nAt least one extra-pelvic lymph node ≥2 cm\r\nAt least one extra-pelvic lymph node ≥1 cm if the patients also have at least one pelvic lymph node ≥2 cm\r\nMeasurable disease or bone lesions that are evaluable according to PCWG3 criteria.\r\nIneligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:\r\n\r\nActivities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4/5;\r\n4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4;\r\nA Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire;\r\nBody mass index (BMI) ≤21 kg/m² and/or >10% weight loss in the last 6 months;\r\nTimed up and go test (TUG) >14 sec.\r\nAdequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L and platelets ≥80 x10⁹/L.\r\nAdequate liver function: alanine aminotransferase (ALT) <2 x upper limit of normal (ULN) and bilirubin <1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). For patients with documented liver metastasis, ALT <5 x ULN is acceptable.\r\nAdequate renal function: calculated creatinine clearance >30 ml/min (using the Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology Collaboration [CKD EPI) method).\r\nFor sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment.\r\nAffiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\r\nWilling and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.'}

{'Arm - Disease - Indication': 'Metastatic Castration-Naive Prostate Cancer\n'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03740165

{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': "Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}

{'Arm - Disease - Indication': 'First-Line BRCA Non-mutated Advanced Epithelial Ovarian Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03740165

{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': "Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}

{'Arm - Disease - Indication': 'First-Line BRCA Non-mutated Advanced Epithelial Ovarian Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03740165

{'Official Title': 'A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.\n\nThe primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.', 'Condition': 'Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms', 'Detailed Description': "Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms:\n\nPembrolizumab + Olaparib,\nPembrolizumab + Placebo for Olaparib\nPlacebo for Pembrolizumab + Placebo for Olaparib\n\nAt Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected:\n\nup to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle\nup to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or\nup to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle.\nDocetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nHas histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer\nHas just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery\nIs a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting\nCandidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25\nIs able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1\nFemale participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\nHas adequate organ function'}

{'Arm - Disease - Indication': 'First-Line BRCA Non-mutated Advanced Epithelial Ovarian Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05580562

{'Official Title': 'ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.', 'Condition': 'Glioma', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAble to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\r\nBody weight ≥ 10 kg at time of randomization.\r\nHistologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS] in a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory). [Site to provide (as available): ≥ 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]\r\nCompleted standard frontline radiotherapy within 2 to 6 weeks prior to randomization. Standard frontline radiotherapy is defined as a dose of 54 to 60 Gy at 1.8 to 2.2 Gy/fraction. Radiotherapy must be initiated within 12 weeks from initial diagnosis of H3 K27M-mutant diffuse glioma and within 8 weeks of most recent surgical resection/biopsy.\r\nKarnofsky Performance Status or Lansky Performance Status ≥ 70 at time of randomization.\r\nStable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid)."}

{'Arm - Disease - Indication': ' Newly diagnosed H3 K27M-mutant diffuse glioma '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05580562

{'Official Title': 'ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.', 'Condition': 'Glioma', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAble to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\r\nBody weight ≥ 10 kg at time of randomization.\r\nHistologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS] in a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory). [Site to provide (as available): ≥ 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]\r\nCompleted standard frontline radiotherapy within 2 to 6 weeks prior to randomization. Standard frontline radiotherapy is defined as a dose of 54 to 60 Gy at 1.8 to 2.2 Gy/fraction. Radiotherapy must be initiated within 12 weeks from initial diagnosis of H3 K27M-mutant diffuse glioma and within 8 weeks of most recent surgical resection/biopsy.\r\nKarnofsky Performance Status or Lansky Performance Status ≥ 70 at time of randomization.\r\nStable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid)."}

{'Arm - Disease - Indication': ' Newly diagnosed H3 K27M-mutant diffuse glioma '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05580562

{'Official Title': 'ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.', 'Condition': 'Glioma', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAble to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\r\nBody weight ≥ 10 kg at time of randomization.\r\nHistologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry [IHC] or next-generation sequencing [NGS] in a Clinical Laboratory Improvement Amendments [CLIA]-certified or equivalent laboratory). [Site to provide (as available): ≥ 10 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.]\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\r\nAt least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. [Site to also provide all available MRIs completed prior to initiating treatment with study intervention.]\r\nCompleted standard frontline radiotherapy within 2 to 6 weeks prior to randomization. Standard frontline radiotherapy is defined as a dose of 54 to 60 Gy at 1.8 to 2.2 Gy/fraction. Radiotherapy must be initiated within 12 weeks from initial diagnosis of H3 K27M-mutant diffuse glioma and within 8 weeks of most recent surgical resection/biopsy.\r\nKarnofsky Performance Status or Lansky Performance Status ≥ 70 at time of randomization.\r\nStable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg/day increase (based on dexamethasone dose or equivalent dose of an alternative steroid)."}

{'Arm - Disease - Indication': ' Newly diagnosed H3 K27M-mutant diffuse glioma '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04853043

{'Official Title': 'APK Mutant: A Single Arm Phase II Study of Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'A prospective, multi-center, phase II study of 21 patients to evaluate the efficacy of the EGFR inhibitor, Cetuximab in patients with mCRC harboring APC, TP53 and RAS mutations.', 'Condition': 'Colorectal Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\n\nMale or female subject aged ≥ 18 years.\nHistologically confirmed metastatic colorectal adenocarcinoma with mutant APC, TP53 and KRAS genes as determined by the local CLIA-certified laboratory are eligible. All RAS mutations are allowed (KRAS, NRAS, HRAS). Patients with wild type KRAS, APC or TP53 are ineligible..\nProgression or unwanted toxicities on atleast 2 prior lines of treatment including 5-Flourouracil, oxaliplatin and irinotecan based regimen\nStudy participants must have measurable disease by RECIST 1.1 criteria by CT or MRI.\nECOG Performance Status ≤ 2.\nStudy participants with treated and/or stable brain metastases are allowed\nStudy participants must have anticipated life expectancy > 3 months\nAdequate organ function as defined as:\n\nHematologic:\n\nAbsolute neutrophil count (ANC) ≥ ≥1000/µL\nPlatelet count ≥ 100,000/mm3\nHemoglobin ≥ 9 g/dL\nHepatic:\n\nSerum Bilirubin ≤ 2 x ULN or ≤ 3 x ULN for subjects with Gilbert's syndrome\nAspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases)\nRenal:\n\nSerum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed)\nFor female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\nWomen < 50 years of age:\n\nAmenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\nLuteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\nUnderwent surgical sterilization (bilateral oophorectomy or hysterectomy).\nWomen ≥ 50 years of age:\n\nAmenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\nHad radiation-induced menopause with last menses >1 year ago; or\nHad chemotherapy-induced menopause with last menses >1 year ago; or\nUnderwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\nFemale subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for atleast 12 months after last study treatment administration.\nMale subjects must agree to use a condom during intercourse for the duration of study therapy and for atleast 12 months after last study treatment administration.\nRecovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator.\nAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines."}

{'Arm - Disease - Indication': 'Third Line Mutant APC, TP53 and RAS Refractory Metastatic Colorectal Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05987358

{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation.\n', 'Brief Summary': 'This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma.\n', 'Condition': 'Biliary Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nage ≥18 years old, ≤75 years old (calculated on the date of signing the informed consent); Eastern Cooperative oncology Group (ECOG) score 0 ~ 2.\nTumor tissue samples must be provided for genetic testing (10 puncture paraffin sections or 5 surgical paraffin sections).\nPatients with viral hepatitis: Patients should be treated symptomatically until the virus is stable before enrollment, and treatment should be maintained during the experimental period.\nThe main organs have good functions.\nMeet the criteria for advanced biliary carcinoma:\n\ncholangiocarcinoma histologically or cytologically confirmed\nLocally advanced, relapsing, and/or metastatic disease that is not operable and has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors V1.1 (RECIST 1.1) criteria.\nPrevious gemcitabine and fluorouracil (and/or platinum-based) drug therapy failed.\nWomen of reproductive age should agree that they must use effective contraception during the study period and for 6 months after the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period.\nThe subjects voluntarily joined the study, signed the informed consent, and the compliance was good.'}

{'Arm - Disease - Indication': 'IDH1 Mutated Unresectable Locally Advanced Relapsing and/or Metastatic Biliary Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05987358

{'Official Title': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation.\n', 'Brief Summary': 'This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma.\n', 'Condition': 'Biliary Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nage ≥18 years old, ≤75 years old (calculated on the date of signing the informed consent); Eastern Cooperative oncology Group (ECOG) score 0 ~ 2.\nTumor tissue samples must be provided for genetic testing (10 puncture paraffin sections or 5 surgical paraffin sections).\nPatients with viral hepatitis: Patients should be treated symptomatically until the virus is stable before enrollment, and treatment should be maintained during the experimental period.\nThe main organs have good functions.\nMeet the criteria for advanced biliary carcinoma:\n\ncholangiocarcinoma histologically or cytologically confirmed\nLocally advanced, relapsing, and/or metastatic disease that is not operable and has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors V1.1 (RECIST 1.1) criteria.\nPrevious gemcitabine and fluorouracil (and/or platinum-based) drug therapy failed.\nWomen of reproductive age should agree that they must use effective contraception during the study period and for 6 months after the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period.\nThe subjects voluntarily joined the study, signed the informed consent, and the compliance was good.'}

{'Arm - Disease - Indication': 'IDH1 Mutated Unresectable Locally Advanced Relapsing and/or Metastatic Biliary Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05457959

{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': "This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}

{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05457959

{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': "This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}

{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05457959

{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': "This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}

{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05457959

{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': "This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}

{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05457959

{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': "This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}

{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05457959

{'Official Title': 'A Placebo-Controlled, Single (Participant) Blind Trial to Evaluate the Safety, Tolerability, and Early Immunogenicity of Peptide-Pulsed Dendritic Cell Vaccination With Nivolumab and Ipilimumab in Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Brief Summary': "This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.\n", 'Condition': 'Diffuse Hemispheric Glioma, H3 G34-Mutant\n', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the safety and tolerability of nivolumab/ipilimumab and peptide-pulsed dendritic cell (ppDC) vaccination in diffuse hemispheric glioma H3 G34-mutant (DHG) participants undergoing surgical resection.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether nivolumab/ipilimumab and/or ppDC vaccination facilitate intratumoral T cell-mediated anti-tumor immune activation in progressive DHG.\n\nII. To determine whether nivolumab/ipilimumab and/or ppDC vaccination stimulate systemic adaptive anti-tumor immunity in progressive DHG.\n\nOUTLINE: Patients are sequentially assigned to 2 cohorts.\n\nCOHORT 1 (Pre-Surgical Resection): Patients are randomized to 1 of 3 arms.\n\nARM A: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC intradermally (ID) in both arms with poly ICLC intramuscularly (IM) on day -10 and placebo intravenously (IV) on day -9 prior to standard of care surgical resection.\n\nARM B: Patients undergo leukapheresis 10 days prior to first injection. Patients receive placebo ID in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nARM C: Patients undergo leukapheresis 10 days prior to first injection. Patients receive ppDC ID divided in both arms with poly ICLC IM on day -10 and nivolumab IV and ipilimumab IV on day -9 prior to standard of care surgical resection.\n\nCOHORT 2 (Post-Surgical Resection): Patients are assigned to 1 of 3 arms.\n\nARM A: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and placebo IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM B: Within 30 days of surgical resection, patients receive placebo ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nARM C: Within 30 days of surgical resection, patients receive ppDC ID in both arms with poly ICLC IM and nivolumab IV on day 1 of each cycle. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Post-treatment, patients may receive nivolumab IV on day 1 of each cycle. Cycles repeat every 4 weeks for up to 24 months following surgical resection in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days and 6 months and every 6 months for up to 2 years.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants between the ages of 13 and 60 years with pathologically-confirmed diagnosis of (or pathology re-review consistent with) DHG will be enrolled in this study\nAll participants must be undergoing clinically indicated resection surgical resection with the goal of cytoreduction\nParticipants must undergo human leukocyte antigen (HLA) testing\nA female participant who has childbearing potential must have negative urine or serum pregnancy test 72 hours prior to the first dose and be willing to use adequate method of contraception for course of study and 120 days after last dose\nThe participant (or legally acceptable representative if applicable) provides informed consent (and written assent from minors) for the trial\nHave unequivocal evidence for contrast-enhancing tumor progression by modified response assessment in neuro-oncology (mRANO) criteria based on MRI scan within 72 days prior to enrollment. This criterion will be reviewed by investigators prior to enrollment\nAn interval of the following durations prior to enrollment:\n\nAt least 14 days from prior surgical resection\nAt least 7 days from prior stereotactic biopsy\nAt least 12 weeks from prior radiotherapy, unless there is unequivocal histologic confirmation of tumor progression\nAt least 23 days from prior chemotherapy\nAt least 42 days from nitrosureas\nHave sufficient archival tumor tissue confirming high-grade glioma (HGG) or variants for submission following registration. The following amount of tissue is required: 1 formalin-fixed, paraffin embedded (FFPE) tissue block (preferred) or 10 FFPE unstained slides (5 um thick)\nHave a Karnofsky Performance Status (KPS) >= 70, if participant age >= 16. Have a Lansky Performance Status (LPS) >= 70, if participant age < 16\nAbsolute neutrophil count (ANC) >= 1500/uL (within 14 days prior to start of study treatment)\nPlatelets >= 100 000/uL (microliter) (within 14 days prior to the start of study treatment)\nHemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 14 days prior to the start of study treatment)\n\nNote: Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\nCreatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) (within 14 days prior to the start of study treatment)\n\nNote: Creatinine clearance (CrCl) should be calculated per institutional standard\nTotal bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (within 14 days prior to the start of study treatment)\nAspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN (=< 5 x ULN for participants with liver metastases) (within 14 days prior to the start of study treatment)\nInternational normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)\nActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 14 days prior to the start of study treatment)'}

{'Arm - Disease - Indication': 'H3 G34 Mutant Recurrent Progressive Diffuse Hemispheric Glioma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02773524

{'Official Title': 'A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)\n', 'Brief Summary': 'A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)\n', 'Condition': 'Gastro-Oesophageal Cancer\n', 'Detailed Description': 'Purpose:\n\nThe purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma.\n\nWho is it for:\n\nYou may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy.\n\nTrial Details:\n\nParticipants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.', 'Inclusion Criteria': 'Inclusion Criteria\n\nAdults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which:\n\nhas arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and\nis of adenocarcinoma or undifferentiated carcinoma histology , and\nis evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and\nhas failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue.\n\nNote: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment.\n\nHER2-positive participants must have received trastuzumab.\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\nAbility to swallow oral medication.\nAdequate bone marrow function (Platelets ≥100x109/L; Absolute Neutrophil Count (ANC) ≥1.5x109/L and Haemoglobin ≥ 9.0g/dL).\nAdequate renal function (Creatinine clearance >50 ml/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine ≤1.5 x Upper Limit of Normal (ULN).\nAdequate liver function (Serum total bilirubin ≤1.5 x ULN, and INR ≤ 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤2.5 x ULN (≤ 5 x ULN for participants with liver metastases)). Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists.\nAdequate cardiac function (Left Ventricular Ejection Fraction (LVEF) ≥ 50% or above the lower limit of normal (LLN) for the Institution (whichever is lower). Cardiac function should be assessed within 3 months prior to randomisation, but after completion of any anthracycline-containing chemotherapy.\nWilling and able to comply with all study requirements, including treatment, timing, and/or nature of required assessments and follow-up.\nStudy treatment both planned and able to start within 7 days after randomisation (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday).\nSigned, written informed consent.'}

{'Arm - Disease - Indication': 'Adult Metastatic or Locally Recurrent Refractory Gastro-Oesophageal Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02773524

{'Official Title': 'A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)\n', 'Brief Summary': 'A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)\n', 'Condition': 'Gastro-Oesophageal Cancer\n', 'Detailed Description': 'Purpose:\n\nThe purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma.\n\nWho is it for:\n\nYou may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy.\n\nTrial Details:\n\nParticipants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.', 'Inclusion Criteria': 'Inclusion Criteria\n\nAdults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which:\n\nhas arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and\nis of adenocarcinoma or undifferentiated carcinoma histology , and\nis evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and\nhas failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue.\n\nNote: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment.\n\nHER2-positive participants must have received trastuzumab.\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\nAbility to swallow oral medication.\nAdequate bone marrow function (Platelets ≥100x109/L; Absolute Neutrophil Count (ANC) ≥1.5x109/L and Haemoglobin ≥ 9.0g/dL).\nAdequate renal function (Creatinine clearance >50 ml/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine ≤1.5 x Upper Limit of Normal (ULN).\nAdequate liver function (Serum total bilirubin ≤1.5 x ULN, and INR ≤ 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤2.5 x ULN (≤ 5 x ULN for participants with liver metastases)). Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists.\nAdequate cardiac function (Left Ventricular Ejection Fraction (LVEF) ≥ 50% or above the lower limit of normal (LLN) for the Institution (whichever is lower). Cardiac function should be assessed within 3 months prior to randomisation, but after completion of any anthracycline-containing chemotherapy.\nWilling and able to comply with all study requirements, including treatment, timing, and/or nature of required assessments and follow-up.\nStudy treatment both planned and able to start within 7 days after randomisation (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday).\nSigned, written informed consent.'}

{'Arm - Disease - Indication': 'Adult Metastatic or Locally Recurrent Refractory Gastro-Oesophageal Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05270044

{'Official Title': 'Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group', 'Brief Summary': 'The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).', 'Condition': 'Melanoma', 'Detailed Description': 'This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial.\r\n\r\nParticipants with completely resected cutaneous melanoma and documented BRAF V600E/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between:\r\n\r\nstage IIB (i.e., pT3b or pT4a)\r\nstage IIC (i.e., pT4b).\r\nThe long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nPre-Screening\r\n\r\nMale or female ≥ 18 years of age;\r\nSurgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa;\r\nSentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma.\r\nSentinel node (SN) staged node negative (pN0);\r\nAvailable tumour sample for central determination of the BRAF V600E/K mutation.\r\nScreening\r\n\r\nMelanoma confirmed centrally to be BRAF V600E/K mutation-positive;\r\nParticipant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1);\r\nNo more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;\r\nRecovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);\r\nECOG performance status of 0 or 1;\r\nAdequate haematological function as defined as Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L and Hemoglobin\r\n\r\n≥ 9.0 g/dL;\r\n\r\nAdequate renal function as defined as Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min;\r\nAdequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;\r\nAdequate hepatic function as defined as Serum total bilirubin ≤ 1.5 x ULN and < 2 mg/dL, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN;\r\nAdequate cardiac function as defined as LVEF ≥ 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value ≤ 480 msec and no history of QT syndrome;\r\nAdequate coagulation function, defined as INR ≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range;\r\nNegative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;\r\nFemale patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for ≥30 days after last administration."}

{'Arm - Disease - Indication': 'Fully Resected BRAF V600E-Positive Stage IIB or Stage IIC Cutaneous Melanoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05270044

{'Official Title': 'Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group', 'Brief Summary': 'The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).', 'Condition': 'Melanoma', 'Detailed Description': 'This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial.\r\n\r\nParticipants with completely resected cutaneous melanoma and documented BRAF V600E/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between:\r\n\r\nstage IIB (i.e., pT3b or pT4a)\r\nstage IIC (i.e., pT4b).\r\nThe long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nPre-Screening\r\n\r\nMale or female ≥ 18 years of age;\r\nSurgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa;\r\nSentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma.\r\nSentinel node (SN) staged node negative (pN0);\r\nAvailable tumour sample for central determination of the BRAF V600E/K mutation.\r\nScreening\r\n\r\nMelanoma confirmed centrally to be BRAF V600E/K mutation-positive;\r\nParticipant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1);\r\nNo more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;\r\nRecovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);\r\nECOG performance status of 0 or 1;\r\nAdequate haematological function as defined as Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L and Hemoglobin\r\n\r\n≥ 9.0 g/dL;\r\n\r\nAdequate renal function as defined as Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min;\r\nAdequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;\r\nAdequate hepatic function as defined as Serum total bilirubin ≤ 1.5 x ULN and < 2 mg/dL, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN;\r\nAdequate cardiac function as defined as LVEF ≥ 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value ≤ 480 msec and no history of QT syndrome;\r\nAdequate coagulation function, defined as INR ≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range;\r\nNegative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;\r\nFemale patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for ≥30 days after last administration."}

{'Arm - Disease - Indication': 'Fully Resected BRAF V600E-Positive Stage IIB or Stage IIC Cutaneous Melanoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04322539

{'Official Title': 'A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.', 'Condition': 'Metastatic Colorectal Cancer, Metastatic Colon Cancer', 'Detailed Description': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib in combination with BSC versus placebo in combination with BSC in metastatic colorectal cancer participants who have progressed on, or were intolerant to, chemotherapy, anti-VEGF and anti-EGFR biologics, and TAS-102 or regorafenib. Participants with MSI-H/MMR deficient tumors must have also received an immune checkpoint inhibitor if approved and available and if deemed appropriate. Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available and if deemed appropriate.\n\nMetastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.', 'Inclusion Criteria': "Inclusion Criteria:\n\nProvide written informed consent;\nAge ≥18 years;\nHistologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines;\nParticipants must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Participants are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Participants who have been treated with both TAS-102 and regorafenib are permitted. Participants must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy;\nParticipants with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the participant's country unless the patient is ineligible for treatment with a checkpoint inhibitor;\nParticipants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Participants who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible;\nBody weight ≥40kg;\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1;\nHave measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions;\nExpected survival >12 weeks.\nFor female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male participants involved in this clinical trial if they have a partner of childbirth potential, and male participants must always use a condom.\nParticipants with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the participant's home country unless the patient is ineligible for treatment with a BRAF inhibitor."}

{'Arm - Disease - Indication': 'Metastatic Colorectal Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04322539

{'Official Title': 'A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer', 'Brief Summary': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.', 'Condition': 'Metastatic Colorectal Cancer, Metastatic Colon Cancer', 'Detailed Description': 'This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib in combination with BSC versus placebo in combination with BSC in metastatic colorectal cancer participants who have progressed on, or were intolerant to, chemotherapy, anti-VEGF and anti-EGFR biologics, and TAS-102 or regorafenib. Participants with MSI-H/MMR deficient tumors must have also received an immune checkpoint inhibitor if approved and available and if deemed appropriate. Subjects with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available and if deemed appropriate.\n\nMetastatic colorectal cancer cannot be cured by surgery. Therefore, treatment principals are primarily aimed at controlling disease progression and prolonging survival. Standard first- and second-line therapy includes cytotoxic drugs such as 5-fluorouracil, oxaliplatin, and irinotecan; anti-VEGF therapy; and, if RAS wild type, anti-EGFR therapy. After the first two lines of chemotherapy, standard third-line treatment is either TAS-102 or regorafenib. There are currently no effective treatments for patients who have progressed on standard, approved therapies, and treatment options include reuse of prior therapies, clinical trials or BSC. Consequently, there is an unmet medical need for additional safe and effective treatment.', 'Inclusion Criteria': "Inclusion Criteria:\n\nProvide written informed consent;\nAge ≥18 years;\nHistologically and/or cytologically documented metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be documented, according to country level guidelines;\nParticipants must have progressed on or been intolerant to treatment with either trifluridine/tipiracil (TAS-102) or regorafenib. Participants are considered intolerant to TAS-102 or regorafenib if they have received at least 1 dose of either agents and were discontinued from therapy for reasons other than disease progression. Participants who have been treated with both TAS-102 and regorafenib are permitted. Participants must also have been previously treated with standard approved therapies: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy;\nParticipants with microsatellite-high (MSI-H) or mismatch repair deficient (dMMR) tumors must have been treated with immune checkpoint inhibitors if approved and available in the participant's country unless the patient is ineligible for treatment with a checkpoint inhibitor;\nParticipants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxaliplatin in the metastatic setting. Participants who developed metastatic disease more than 6 months after completion of oxaliplatin-containing adjuvant treatment must be treated with oxaliplatin-based therapy in the metastatic setting to be eligible;\nBody weight ≥40kg;\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1;\nHave measurable disease according to RECIST Version 1.1, assessed locally. Tumors that were treated with radiotherapy are not measurable per RECIST Version 1.1, unless there has been documented progression of those lesions;\nExpected survival >12 weeks.\nFor female participants of childbearing potential and male participants with partners of childbearing potential, agreement to use a highly effective form(s) of contraception, that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include: oral hormonal contraception (combined estrogen/ progestogen, or progestogen-only) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Highly effective contraception should always be combined with an additional barrier method (eg, diaphragm, with spermicide). The same criteria are applicable to male participants involved in this clinical trial if they have a partner of childbirth potential, and male participants must always use a condom.\nParticipants with BRAF-mutant tumors must have been treated with a BRAF inhibitor if approved and available in the participant's home country unless the patient is ineligible for treatment with a BRAF inhibitor."}

{'Arm - Disease - Indication': 'Metastatic Colorectal Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04844528

{'Official Title': 'Randomized Phase 2 Studying the Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC)\n', 'Brief Summary': 'This is a randomized, phase II, double-blind, placebo-controlled trial with planned crossover to the intervention arm after 1 year.\n\nConsenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive either oral nicotinamide 500 mg twice daily (BID) for 1 year or oral placebo 1 tablet twice daily for 1 year. Patients will be stratified according to CLL therapy and the number of prior NMSC. At the end of 1 year, patients will undergo dermatologic examination and the number of new NMSC will be quantified. The number of patients who develop new NMSC in each arm will be documented. At this time, patients will be unblinded and all patients will receive Nicotinamide 500 mg BID for an additional year. At the end of this second year, patients will again undergo dermatologic examination, and the number of new NMSC will be quantified. The number of patients who develop NMSC will be documented. Skin biopsies will be taken for correlative studies.\n\nEnrollment will be split into two parts separated by an interim analysis. Part 1 will accrue 40 patients: 20 to each arm. After 40 patients have completed their 12 month visit an interim futility analysis will be conducted prior to recruiting more patients. The study will stop if the difference in the number of patients with NMSC between control and treatment arms is 0 or less (i.e., absolutely no evidence that the treatment is better than control). If the trial is not stopped, the investigators will proceed with Part 2 and recruit 46 more patients.\n\n', 'Condition': 'Chronic Lymphocytic Leukemia\n', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\n\nMale or female subject aged ≥ 18 years.\nConfirmed diagnosis of CLL or small lymphocytic leukemia (SLL) per iwCLL 2018 criteria.\nHistory of ≥1 non-melanoma skin cancer (NMSC) diagnosed within the last 5 years\nAdequate liver function as defined as:\n\nTotal Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)\n\n---Subjects with a known diagnosis of Gilbert's Syndrome: direct bilirubin ≤ 1.5x ULN\n\nAST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN\nFor female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n--Women < 50 years of age:\n\nAmenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\nLuteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\nUnderwent surgical sterilization (bilateral oophorectomy or hysterectomy).\nWomen ≥ 50 years of age:\n\nAmenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\nHad radiation-induced menopause with last menses >1 year ago; or\nHad chemotherapy-induced menopause with last menses >1 year ago; or\nUnderwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\nFemale subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1."}

{'Arm - Disease - Indication': 'Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers\n'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04844528

{'Official Title': 'Randomized Phase 2 Studying the Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC)\n', 'Brief Summary': 'This is a randomized, phase II, double-blind, placebo-controlled trial with planned crossover to the intervention arm after 1 year.\n\nConsenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive either oral nicotinamide 500 mg twice daily (BID) for 1 year or oral placebo 1 tablet twice daily for 1 year. Patients will be stratified according to CLL therapy and the number of prior NMSC. At the end of 1 year, patients will undergo dermatologic examination and the number of new NMSC will be quantified. The number of patients who develop new NMSC in each arm will be documented. At this time, patients will be unblinded and all patients will receive Nicotinamide 500 mg BID for an additional year. At the end of this second year, patients will again undergo dermatologic examination, and the number of new NMSC will be quantified. The number of patients who develop NMSC will be documented. Skin biopsies will be taken for correlative studies.\n\nEnrollment will be split into two parts separated by an interim analysis. Part 1 will accrue 40 patients: 20 to each arm. After 40 patients have completed their 12 month visit an interim futility analysis will be conducted prior to recruiting more patients. The study will stop if the difference in the number of patients with NMSC between control and treatment arms is 0 or less (i.e., absolutely no evidence that the treatment is better than control). If the trial is not stopped, the investigators will proceed with Part 2 and recruit 46 more patients.\n\n', 'Condition': 'Chronic Lymphocytic Leukemia\n', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\n\nMale or female subject aged ≥ 18 years.\nConfirmed diagnosis of CLL or small lymphocytic leukemia (SLL) per iwCLL 2018 criteria.\nHistory of ≥1 non-melanoma skin cancer (NMSC) diagnosed within the last 5 years\nAdequate liver function as defined as:\n\nTotal Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)\n\n---Subjects with a known diagnosis of Gilbert's Syndrome: direct bilirubin ≤ 1.5x ULN\n\nAST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN\nFor female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n--Women < 50 years of age:\n\nAmenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\nLuteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\nUnderwent surgical sterilization (bilateral oophorectomy or hysterectomy).\nWomen ≥ 50 years of age:\n\nAmenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\nHad radiation-induced menopause with last menses >1 year ago; or\nHad chemotherapy-induced menopause with last menses >1 year ago; or\nUnderwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\nFemale subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1."}

{'Arm - Disease - Indication': 'Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers\n'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03981614

{'Official Title': 'Combination of MEK Inhibitor Binimetinib and CDK4/6 Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers\n', 'Brief Summary': 'This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer.\n', 'Condition': 'Metastatic Colorectal Carcinoma\nStage IV Colorectal Cancer AJCC v8\nStage IVA Colorectal Cancer AJCC v8\nStage IVB Colorectal Cancer AJCC v8\nStage IVC Colorectal Cancer AJCC v8\nUnresectable Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. The primary objective is to compare the progression-free survival (PFS) between those randomized to palbociclib/binimetinib and those randomized to trifluridine and tipiracil hydrochloride (TAS-102) in patients with refractory KRAS- or NRAS-mutant metastatic colorectal cancer (CRC).\n\nSECONDARY OBJECTIVES:\n\nI. To compare the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nII. To compare the overall survival (OS) between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nIII. To determine the safety and tolerability of the recommended phase II dose of palbociclib in combination with binimetinib in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nCORRELATIVE RESEARCH OBJECTIVES:\n\nI. To determine the tumor mutational profiles that characterize groups of patients that predict for response or resistance to combination of palbociclib/binimetinib.\n\nII. To determine the correlation between circulating tumor deoxyribonucleic acid (DNA) and tumor response or resistance to therapy with palbociclib/binimetinib or TAS-102.\n\nIII. To determine the association between Consensus Molecular Subtype based on gene expression profiling and response or resistance to combination of palbociclib/binimetinib.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and palbociclib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\n\nAfter completion of study treatment, patients are followed up within 30-37 days and then every 12 weeks for up to 24 months.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistological confirmation of colorectal cancer that is metastatic and/or unresectable\nDocumented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\nMeasurable disease\nEastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\nPreviously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nAbsolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nPlatelet count >= 75 x 10^9/L without transfusions (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nHemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nAspartate transaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nNegative serum beta-human chorionic gonadotropin (B-HCG) pregnancy test done =< 7 days prior to registration/randomization for women of childbearing potential only\nAble to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nAble and willing to provide informed written consent and able to comply with protocol requirement\nAble and willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nNOTE: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nWilling to provide blood and tissue samples for mandatory correlative research purposes\nPatient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)\nCROSSOVER INCLUSION CRITERIA: Histological confirmation of colorectal cancer that is metastatic and/or unresectable\nCROSSOVER INCLUSION CRITERIA: Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a CLIA-certified laboratory\nCROSSOVER INCLUSION CRITERIA: Measurable disease\nCROSSOVER INCLUSION CRITERIA: ECOG performance status (PS) of 0 or 1\nCROSSOVER INCLUSION CRITERIA: Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nCROSSOVER INCLUSION CRITERIA: ANC >= 1.5 x 10^9/L (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Platelet count >= 75 x 10^9/L without transfusion (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Hgb >= 9 g/dL (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Total bilirubin =< 1.5 x ULN (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: AST and ALT =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Negative serum beta-HCG pregnancy test done =< 7 days prior to re-registration for women of childbearing potential only\nCROSSOVER INCLUSION CRITERIA: Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nCROSSOVER INCLUSION CRITERIA: Able and willing to provide informed written consent and able to comply with protocol requirements\nCROSSOVER INCLUSION CRITERIA: Able and willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nNOTE: During the Active Monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nCROSSOVER INCLUSION CRITERIA: Willing to provide blood samples for mandatory correlative research purposes\nCROSSOVER INCLUSION CRITERIA: Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)'}

{'Arm - Disease - Indication': 'KRAS/NRAS Positive Metastatic Refractory Unresectable Colorectal Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03981614

{'Official Title': 'Combination of MEK Inhibitor Binimetinib and CDK4/6 Inhibitor Palbociclib in KRAS and NRAS Mutant Metastatic Colorectal Cancers\n', 'Brief Summary': 'This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving binimetinib and palbociclib may work better compared to TAS-102 alone in treating patients with colorectal cancer.\n', 'Condition': 'Metastatic Colorectal Carcinoma\nStage IV Colorectal Cancer AJCC v8\nStage IVA Colorectal Cancer AJCC v8\nStage IVB Colorectal Cancer AJCC v8\nStage IVC Colorectal Cancer AJCC v8\nUnresectable Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\n\nI. The primary objective is to compare the progression-free survival (PFS) between those randomized to palbociclib/binimetinib and those randomized to trifluridine and tipiracil hydrochloride (TAS-102) in patients with refractory KRAS- or NRAS-mutant metastatic colorectal cancer (CRC).\n\nSECONDARY OBJECTIVES:\n\nI. To compare the overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nII. To compare the overall survival (OS) between those randomized to palbociclib/binimetinib and those randomized to TAS-102 in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nIII. To determine the safety and tolerability of the recommended phase II dose of palbociclib in combination with binimetinib in patients with refractory KRAS- or NRAS-mutant metastatic CRC.\n\nCORRELATIVE RESEARCH OBJECTIVES:\n\nI. To determine the tumor mutational profiles that characterize groups of patients that predict for response or resistance to combination of palbociclib/binimetinib.\n\nII. To determine the correlation between circulating tumor deoxyribonucleic acid (DNA) and tumor response or resistance to therapy with palbociclib/binimetinib or TAS-102.\n\nIII. To determine the association between Consensus Molecular Subtype based on gene expression profiling and response or resistance to combination of palbociclib/binimetinib.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and palbociclib PO once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\n\nAfter completion of study treatment, patients are followed up within 30-37 days and then every 12 weeks for up to 24 months.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nHistological confirmation of colorectal cancer that is metastatic and/or unresectable\nDocumented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\nMeasurable disease\nEastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\nPreviously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nAbsolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nPlatelet count >= 75 x 10^9/L without transfusions (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nHemoglobin (Hgb) >= 9 g/dL (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nAspartate transaminase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration/randomization unless otherwise noted)\nNegative serum beta-human chorionic gonadotropin (B-HCG) pregnancy test done =< 7 days prior to registration/randomization for women of childbearing potential only\nAble to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nAble and willing to provide informed written consent and able to comply with protocol requirement\nAble and willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nNOTE: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nWilling to provide blood and tissue samples for mandatory correlative research purposes\nPatient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)\nCROSSOVER INCLUSION CRITERIA: Histological confirmation of colorectal cancer that is metastatic and/or unresectable\nCROSSOVER INCLUSION CRITERIA: Documented mutation in KRAS or NRAS (codon 12, 13, 59, 61, 117, or 146) in tumor tissue from primary or metastatic site, tested by a CLIA-certified laboratory\nCROSSOVER INCLUSION CRITERIA: Measurable disease\nCROSSOVER INCLUSION CRITERIA: ECOG performance status (PS) of 0 or 1\nCROSSOVER INCLUSION CRITERIA: Previously treated with fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy, and an anti-VEGF biological therapy\nCROSSOVER INCLUSION CRITERIA: ANC >= 1.5 x 10^9/L (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Platelet count >= 75 x 10^9/L without transfusion (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Hgb >= 9 g/dL (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Total bilirubin =< 1.5 x ULN (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: AST and ALT =< 2.5 x ULN; =< 5.0 x ULN if known liver metastases (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula (obtained =< 28 days of re-registration unless otherwise noted)\nCROSSOVER INCLUSION CRITERIA: Negative serum beta-HCG pregnancy test done =< 7 days prior to re-registration for women of childbearing potential only\nCROSSOVER INCLUSION CRITERIA: Able to swallow capsules with no surgical or anatomic conditions that would preclude the patient from swallowing and absorbing oral medications\nCROSSOVER INCLUSION CRITERIA: Able and willing to provide informed written consent and able to comply with protocol requirements\nCROSSOVER INCLUSION CRITERIA: Able and willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nNOTE: During the Active Monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up\nCROSSOVER INCLUSION CRITERIA: Willing to provide blood samples for mandatory correlative research purposes\nCROSSOVER INCLUSION CRITERIA: Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)'}

{'Arm - Disease - Indication': 'KRAS/NRAS Positive Metastatic Refractory Unresectable Colorectal Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05920356

{'Official Title': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'Brief Summary': 'The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\r\nNo history of systemic anticancer therapy in metastatic/non-curable settings\r\nEastern Cooperative Oncology Group (ECOG) ≤ 1'}

{'Arm - Disease - Indication': 'Frontline Stage IV or Advanced Stage IIIB/\u200bC Nonsquamous Non-Small Cell Lung Cancer, Negative for PD-L1, and Positive for KRAS p.G12C '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05920356

{'Official Title': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'Brief Summary': 'The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.', 'Condition': 'Non-Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\r\nNo history of systemic anticancer therapy in metastatic/non-curable settings\r\nEastern Cooperative Oncology Group (ECOG) ≤ 1'}

{'Arm - Disease - Indication': 'Frontline Stage IV or Advanced Stage IIIB/\u200bC Nonsquamous Non-Small Cell Lung Cancer, Negative for PD-L1, and Positive for KRAS p.G12C '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02642042

{'Official Title': 'A Phase II Trial of Trametinib With Docetaxel in Patients With KRAS Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies', 'Brief Summary': 'This phase II trial studies how well trametinib and docetaxel work in treating patients with stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come back. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib with docetaxel may work better in treating non-small cell lung cancer.', 'Condition': 'Recurrent Lung Non-Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVES:\r\n\r\nI. To evaluate the response rate (confirmed and unconfirmed) to trametinib plus docetaxel in the entire study population of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive non-small cell lung cancer (NSCLC) patients following one or two prior systemic therapies.\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To evaluate if trametinib plus docetaxel is consistent with promise of activity measured by the response rate in G12C KRAS mutation positive NSCLC patients following one or two prior systemic therapies.\r\n\r\nII. To assess the response rate of this combination in non-G12C KRAS mutation positive NSCLC patients.\r\n\r\nIII. To assess progression-free survival within the G12C and non-G12C KRAS positive subgroups and the entire study population.\r\n\r\nIV. To evaluate the toxicity of the regimen. V. To assess overall survival within G12C positive patients, non-G12C positive patients, and the entire study population.\r\n\r\nTRANSLATIONAL MEDICINE OBJECTIVES:\r\n\r\nI. To evaluate the response rates in the presence of comutations p53 and LKB1. II. To bank specimens for future research.\r\n\r\nOUTLINE:\r\n\r\nPatients receive trametinib orally (PO) on days 1-21. Patients also receive docetaxel intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\r\n\r\nAfter completion of study treatment, patients are followed up every 6 months for 3 years.\r\n\r', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nDISEASE RELATED CRITERIA: Patients must have pathologically confirmed KRAS mutation (at codon 12, 13 and 61) positive non-small cell lung cancer (NSCLC) that is stage IV or recurrent; the specific subtype of KRAS mutation must be known; KRAS mutation testing must have been performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory; CLIA certified commercially available tests are acceptable\r\nDISEASE RELATED CRITERIA: Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to registration; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; non-measurable disease must be assessed within 42 days prior to registration; all known sites of disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST 1.1])\r\nDISEASE RELATED CRITERIA: Patients must not have known brain metastases, leptomeningeal carcinomatosis or spinal cord compression unless: (1) metastases have been locally treated (including stereotactic body radiation therapy [SBRT], whole brain radiotherapy [WBRT], and surgical resection) and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 2 days prior to registration\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must have documented progressive cancer following at least one but no more than two prior regimens of systemic therapy for lung cancer, one of which must have been platinum based combination chemotherapy; treatment with an immune therapy or targeted therapy for advanced disease will be considered a separate regimen and will count toward the prior regimens; maintenance therapy will not be counted as a separate regimen; adjuvant chemotherapy or chemotherapy administered as part of concurrent chemotherapy and radiation therapy for the treatment of lung cancer will not count as a prior regimen of systemic therapy as long as recurrence of patient\'s lung cancer occurred more than 12 months after the last day of chemotherapy\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received any chemotherapy, biologic agent, or any investigational agent within 14 days prior to registration. Patients must have recovered from any adverse events to Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 prior to registration\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Prior treatment with an anti-PD-1 or anti-PDL1 is not required\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received prior docetaxel; patients must not have received therapy with a drug known to be either a mitogen-activated protein kinase (MEK) inhibitor or a phosphatidylinositol 3 kinase (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (AKT)/mammalian target of rapamycin (mTOR) pathway inhibitor\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must have recovered from any adverse effects from prior therapy (except alopecia) to =< CTCAE grade 1 prior to registration\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients may have had prior radiation therapy as long as it has not affected greater than 25% of the bone marrow and at least one measurable lesion is outside the area of prior radiation; at least 7 days must have elapsed since last radiation treatment; patients must have recovered from any adverse events from prior radiation therapy to =< CTCAE grade 1\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have had a major surgery within 28 days prior to registration; patients must have recovered from any adverse effects of prior surgery to the satisfaction of the treating physician; biopsies and central IV access placement are not considered major surgery\r\nPRIOR/CONCURRENT THERAPY CRITERIA: Because the composition, pharmacokinetics (PK), and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including but not limited to St. John\'s wort, kava, ephedra [ma huang], ginko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\nCLINICAL/LABORATORY CRITERIA: Patients must have Zubrod performance status of 0-2\r\nCLINICAL/LABORATORY CRITERIA: Absolute neutrophil count (ANC) >= 1500/mcL; these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Platelet count >= 100,000/mcL; these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Hemoglobin >= 9 grams/dl; these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or =< 5 x IULN for patients with known liver metastases); these results must be obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 40 mL/min; this result must have been obtained within 28 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Patients must be able to swallow oral medications and must not have a gastro-intestinal disorder with diarrhea as a major symptom or that may alter absorption such as malabsorption syndromes or gastric resection\r\nCLINICAL/LABORATORY CRITERIA: Patient must not have prior history of interstitial lung disease or pneumonitis\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have history of significant co-morbid illness inclusive of but not restricted to New York Heart Association class II, congestive cardiac failure, uncontrolled hypertension, history of myocardial infarction, unstable angina, coronary angioplasty, stenting or cerebrovascular accident within 6 months prior to registration or any other illness that in the assessment of the treating physician would compromise the ability of the patient to participate in this study\r\nCLINICAL/LABORATORY CRITERIA: Patients must have corrected QT (QTc) interval =< 480 msec (using the Bazett\'s formula) on electrocardiogram (ECG) performed within 42 days prior to registration; history or evidence of current clinically significant uncontrolled arrhythmias are not eligible; however, patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible; patients must not have atrial fibrillation > grade 2 on the screening ECG; patients with CTCAE grade 1-2 atrial fibrillation on their screening ECG must have a second ECG performed prior to registration and more than 30 days from the screening ECG (either before or after) with the most recent ECG showing stable or improving grade of atrial fibrillation\r\nCLINICAL/LABORATORY CRITERIA: Patients must have a left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (ILLN) by echocardiography (ECHO) or multi-gated acquisition scan (MUGA) within 42 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have untreated or unresolved retinopathy or have a history (or current evidence) of retinal vein occlusion determined by an ophthalmology exam within 42 days prior to registration\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have an immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients, or to dimethyl sulfoxide (DMSO) or other agents used in the study\r\nCLINICAL/LABORATORY CRITERIA: Patients must not have a known history of active hepatitis B or C infection (defined as presence of hepatitis [Hep] B surface antigen [sAg] and/or Hep B deoxyribonucleic acid [DNA] and/or Hep C ribonucleic acid [RNA]); patients must not have a known history of human immunodeficiency virus (HIV) seropositivity\r\nCLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible\r\nCLINICAL/LABORATORY CRITERIA: Patients must not be pregnant or nursing due to the risk of fetal or nursing infant harm; women/men of reproductive potential must have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation and for 4 months after the last dose of the drug; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures\r\nSPECIMEN SUBMISSION CRITERIA: Patients must be offered optional participation in banking of specimens for future research\r\nREGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\r\nREGULATORY CRITERIA: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'}

{'Arm - Disease - Indication': 'Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03912415

{'Official Title': 'An International Randomized Double-blind Clinical Trial of BCD-100 Plus Platinum-based Chemotherapy With and Without Bevacizumab Versus Placebo Plus Platinum-based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer\n', 'Brief Summary': 'This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab\n', 'Condition': 'Cervical Cancer\n', 'Detailed Description': "Subjects will be randomized in a 1:1 ratio to receive either Test Regimen or Comparator Regimen as the first-line treatment for advanced cervical cancer. Subjects will receive study therapy Q3W until progression of the disease or signs of unacceptable toxicity. In the absence of dose-limiting toxicity chemotherapy should be continued for at least 6 cycles, then, upon Investigator's decision and/or subjects' wish, the use of chemotherapy can be stopped while maintenance therapy with BCD-100/Placebo with or without bevacizumab (depending on initial therapy choice) continues until disease progression.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nSigning an IRB/EC-approved informed consent\nFemales ≥ 18 years of age on day of signing informed consent\nHistologically confirmed squamous carcinoma of the cervix\nProgressing thru or recurrent disease treated for curative intent or primary metastatic cervical cancer stage FIGO IVB\nAgreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (using archival biopsy material is only acceptable in subjects in whom obtaining a new sample is contraindicated)\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use a contraceptive method with a failure rate of < 1% per year from the moment of signing informed consent, during the treatment period and at least 6 months after administration of the last dose of study drug. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) is not acceptable method of contraception.'}

{'Arm - Disease - Indication': 'First-Line Advanced Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03912415

{'Official Title': 'An International Randomized Double-blind Clinical Trial of BCD-100 Plus Platinum-based Chemotherapy With and Without Bevacizumab Versus Placebo Plus Platinum-based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer\n', 'Brief Summary': 'This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab\n', 'Condition': 'Cervical Cancer\n', 'Detailed Description': "Subjects will be randomized in a 1:1 ratio to receive either Test Regimen or Comparator Regimen as the first-line treatment for advanced cervical cancer. Subjects will receive study therapy Q3W until progression of the disease or signs of unacceptable toxicity. In the absence of dose-limiting toxicity chemotherapy should be continued for at least 6 cycles, then, upon Investigator's decision and/or subjects' wish, the use of chemotherapy can be stopped while maintenance therapy with BCD-100/Placebo with or without bevacizumab (depending on initial therapy choice) continues until disease progression.", 'Inclusion Criteria': 'Inclusion Criteria:\n\nSigning an IRB/EC-approved informed consent\nFemales ≥ 18 years of age on day of signing informed consent\nHistologically confirmed squamous carcinoma of the cervix\nProgressing thru or recurrent disease treated for curative intent or primary metastatic cervical cancer stage FIGO IVB\nAgreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (using archival biopsy material is only acceptable in subjects in whom obtaining a new sample is contraindicated)\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use a contraceptive method with a failure rate of < 1% per year from the moment of signing informed consent, during the treatment period and at least 6 months after administration of the last dose of study drug. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) is not acceptable method of contraception.'}

{'Arm - Disease - Indication': 'First-Line Advanced Cervical Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04526470

{'Official Title': 'Phase IB/II Study of Alpelisib in Combination With Paclitaxel in Patients With PIK3CA-altered Metastatic/Recurrent Gastric Cancer', 'Brief Summary': 'Alpelisib (BYL719) is a PIK3CA-specific inhibitor, which was developed by Novartis (Basel, Switzerland). Our group conducted pre-clinical study of alpelisib in eight gastric cancer cell lines: four PIK3CA wild-type (SNU638, SNU668, SNU1, and SNU16) and four PIK3CA mutant (SNU719, AGS, SNU601, and MKN). As a result, alpelisib preferentially inhibited the growth of gastric cancer cells with PIK3CA mutations. In addition, alpelisib inhibited cell growth via G1 arrest and subsequently induces apoptosis in GC cells, and this effect is more remarkable in cells harboring PIK3CA mutations. Moreover, alpelisib in combination with paclitaxel showed synergistic cytotoxic effects and significantly increased apoptosis compared with alpelisib or paclitaxel monotherapy in GC cells.\r\n\r\nThe purpose of the study is to define the maximal tolerated dose (MTD) and recommended phase II dose (RP2D) of paclitaxel and alpelisib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and AZD8186 combination therapy as a second-line therapy in patients with advanced gastric cancer with PTEN aberrations. This study is divided into Phase IB and Phase II.', 'Condition': 'Stomach Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nSubject has signed the Informed Consent Form (ICF) prior to any screening procedures being performed\r\nAge ≥ 20 years old of male and female\r\nAt each phase of the trial, subjects who meet the following requirements in each phase will be enrolled.\r\n\r\nPhase IB: Subjects with a histologically-confirmed, advanced/recurrent solid tumor who have progressed on standard therapy or whose disease does not have established standard therapy.\r\nPhase II: Subjects with histologically confirmed locally advanced or metastatic gastric cancer that have progressed after treatment with first-line fluoropyrimidine-based chemotherapy (Tissue samples of gastric cancer must contain PIK3CA gene alterations (e.g. single nucleotide variants, small indels, amplifications, structural variations, etc.) identified by central or local next generation sequencing (NGS). If the subject received adjuvant chemotherapy after curative gastric resection and lymph node dissection, the adjuvant chemotherapy is considered to be the first-line palliative chemotherapy if the disease recurred during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy.\r\nPhase IB: Patient has evaluable disease as per RECIST 1.1. (Measurable lesions are not mandatory for study inclusion.) Phase II: Patient has at least one measurable lesion as per RECIST 1.1.\r\nECOG performance status 0-1\r\nPatient has adequate bone marrow and organ function as defined by the following laboratory values:\r\n\r\nAbsolute neutrophil count (ANC) ≥ 1.5 x 109/L\r\nHemoglobin ≥ 9.0 g/dL\r\nPlatelet ≥ 100 x 109/L\r\nSerum creatinine ≤ ULN (upper limit of normal) or serum creatinine clearance ≥50 mL/min (by Cockcroft-Gault formula, or 24h urine collection)\r\nTotal bilirubin: ≤ 1.5 × ULN Subjects with a bile duct obstruction will be eligible if they meet the criteria after appropriate bile drainage; Patients with Gilbert syndrome should also be included after confirming that the total bilirubin level is ≤ 1.5 x ULN in a follow-up screening test.\r\nPhase Ib: Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 3 x ULN (regardless of liver metastases)\r\nPhase II: AST and ALT ≤ 3 x ULN if liver metastases are absent, or AST and ALT ≤ 5 x ULN if liver metastases are present.\r\nThe subject is able to swallow and retain oral medication\r\nSerum β-HCG test negative within 14 days before the first administration of the study treatment (women of childbearing potential only).\r\nRequirement for contraception must be observed by the subject.'}

{'Arm - Disease - Indication': 'PIK3CA-Altered Locally Advanced Metastatic/Recurrent Gastric Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03909334

{'Official Title': 'An Open-Label Randomized Phase II Study of Combining Osimertinib With and Without Ramucirumab in Tyrosine Kinase Inhibitor (TKI)-naïve Epidermal Growth Factor Receptor (EGFR)-Mutant Locally Advanced or Metastatic NSCLC', 'Brief Summary': 'The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.', 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nWritten informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\r\nAge ≥ 18 years at the time of consent.\r\nHistologically or cytologically confirmed non-squamous, non-small cell lung cancer.\r\nLocally advanced or metastatic disease, not amenable to curative surgery or radiotherapy.\r\nPatients must have one of the following:\r\n\r\nNSCLC which harbours EGFR Exon 19 deletion.\r\nNSCLC which harbours EGFR L858R mutation. EGFR deletion/mutation must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test (either from tissue or ctDNA from blood is allowed). If EGFR deletion/mutation testing has not been done, it should be ordered per standard of care.\r\nEastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).\r\nMeasurable disease per RECIST 1.1.\r\nPatients with brain metastases are eligible if they are asymptomatic, are treated, or are neurologically stable for at least two weeks without the use of steroids or on stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent). These criteria must be met on day of consent.\r\nAbility to take pills by mouth.\r\nPrevious treatment with cytotoxic chemotherapy or immunotherapy is allowed.\r\nPatients must have adequate hematologic, coagulation, hepatic, and renal function. All laboratory tests must be obtained less than 4 weeks from study entry. This includes:\r\n\r\nANC >/= 1,500/mm3\r\nplatelet count >/=100,000/mm3\r\nHgB ≥ 9 g/dL (may be with transfusion)\r\nCreatinine ≤ 1.5x ULN or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).\r\nThe patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in this protocol).\r\nTotal Serum Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN)\r\nSGOT, SGPT ≤ 3 X ULN if no liver metastasis present\r\nSGOT, SGPT ≤ 5 X ULN if liver metastasis present\r\nThe patient has adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) < 1.5 x upper limits of normal [ULN]. Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR ≤ 3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices.\r\nFemales of childbearing potential must have a negative serum pregnancy test within 7 days of starting of treatment. See the protocol for additional details.\r\nFemales of childbearing potential and Non-sterilized males who are sexually active with a female partner of childbearing potential must agree to use adequate contraception as outlined in the protocol."}

{'Arm - Disease - Indication': 'Tyrosine Kinase Inhibitor - Naive EGFR Mutated Previously Treated Locally Advanced or Metastatic Non Small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03909334

{'Official Title': 'An Open-Label Randomized Phase II Study of Combining Osimertinib With and Without Ramucirumab in Tyrosine Kinase Inhibitor (TKI)-naïve Epidermal Growth Factor Receptor (EGFR)-Mutant Locally Advanced or Metastatic NSCLC', 'Brief Summary': 'The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.', 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nWritten informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\r\nAge ≥ 18 years at the time of consent.\r\nHistologically or cytologically confirmed non-squamous, non-small cell lung cancer.\r\nLocally advanced or metastatic disease, not amenable to curative surgery or radiotherapy.\r\nPatients must have one of the following:\r\n\r\nNSCLC which harbours EGFR Exon 19 deletion.\r\nNSCLC which harbours EGFR L858R mutation. EGFR deletion/mutation must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test (either from tissue or ctDNA from blood is allowed). If EGFR deletion/mutation testing has not been done, it should be ordered per standard of care.\r\nEastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).\r\nMeasurable disease per RECIST 1.1.\r\nPatients with brain metastases are eligible if they are asymptomatic, are treated, or are neurologically stable for at least two weeks without the use of steroids or on stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent). These criteria must be met on day of consent.\r\nAbility to take pills by mouth.\r\nPrevious treatment with cytotoxic chemotherapy or immunotherapy is allowed.\r\nPatients must have adequate hematologic, coagulation, hepatic, and renal function. All laboratory tests must be obtained less than 4 weeks from study entry. This includes:\r\n\r\nANC >/= 1,500/mm3\r\nplatelet count >/=100,000/mm3\r\nHgB ≥ 9 g/dL (may be with transfusion)\r\nCreatinine ≤ 1.5x ULN or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).\r\nThe patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in this protocol).\r\nTotal Serum Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN)\r\nSGOT, SGPT ≤ 3 X ULN if no liver metastasis present\r\nSGOT, SGPT ≤ 5 X ULN if liver metastasis present\r\nThe patient has adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) < 1.5 x upper limits of normal [ULN]. Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR ≤ 3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices.\r\nFemales of childbearing potential must have a negative serum pregnancy test within 7 days of starting of treatment. See the protocol for additional details.\r\nFemales of childbearing potential and Non-sterilized males who are sexually active with a female partner of childbearing potential must agree to use adequate contraception as outlined in the protocol."}

{'Arm - Disease - Indication': 'Tyrosine Kinase Inhibitor - Naive EGFR Mutated Previously Treated Locally Advanced or Metastatic Non Small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04686305

{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}

{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04686305

{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}

{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04686305

{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}

{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04686305

{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}

{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04686305

{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}

{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04686305

{'Official Title': 'A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)', 'Brief Summary': 'DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.', 'Condition': 'Locally Advanced or Metastatic Non-Small Cell Lung Cancer', 'Detailed Description': 'Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. No more patients will be enrolled in this part of the study. Part 2, expansions in the treatment naïve setting on any recommended dose level will not be initiated. The evaluation of T-DXd combination treatment with immunotherapy continues in Part 3, assessing T-DXd and MEDI5752 with or without carboplatin (Arms 3A and 3B, respectively), using a dose confirmation and expansion design.\r\n\r\nFor Part 3, patients will be randomized 1:1 to Arms 3A and 3B, beginning with the cohorts receiving the MEDI5752 starting dose (SD). A total of 6 DLT-evaluable patients will be enrolled to the SD cohorts in each arm. If the combination of T-DXd with MEDI5752 at the starting dose is deemed safe, a dose escalation (E1) cohort will be opened for 6 DLT-evaluable patients. Once all open dose confirmation cohorts have 6 DLT-evaluable patients, the SRC will convene to select the MEDI5752 RP2D to be used in the dose-expansion (DE) cohorts of each arm (n=34).\r\n\r\nThe target population of interest (for Part 3) are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who are treatment naïve for recurrent, unresectable or metastatic disease. Patients with tumors that harbor a known genomic alteration or driver for which approved therapies are available are excluded.', 'Inclusion Criteria': 'Inclusion criteria:\r\n\r\nHistologically documented unresectable locally advanced/metastatic non-squamous NSCLC\r\nPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\r\nPart 3: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.\r\nPart 3: Patients must have tumors without known genomic alterations or actionable driver kinases, as determined by existing local test results, for which approved therapies are available are allowed. Patients who received prior adjuvant, neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred > 6 months from end of last therapy\r\nHER2overexpression status as determined by central review of tumor tissue\r\nWHO / ECOG performance status of 0 or 1\r\nMeasurable target disease assessed by the investigator using RECIST 1.1\r\nHas protocol defined adequate organ and bone marrow function\r\nPart 3: Minimum body weight of 35 kg.'}

{'Arm - Disease - Indication': 'First-Line HER2 Overexpressed Treatment-Naive Unresectable Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02555189

{'Official Title': 'Randomized Phase IB/II Study of Enzalutamide With and Without Ribociclib in Patients With Metastatic Castrate Resistant, Chemotherapy Naïve Prostate Cancer That Retains RB Expression\n', 'Brief Summary': 'This partially randomized phase IB/II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with prostate cancer that does not respond to treatment with hormones (hormone resistant), has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naïve, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer.\n', 'Condition': 'Hormone-Resistant Prostate Cancer\nMetastatic Prostate Carcinoma\nProstate Carcinoma Metastatic in the Bone\nStage IV Prostate Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES:\n\nI. To determine the maximum tolerated dose of ribociclib in combination with 160 mg of enzalutamide. (Phase Ib)\n\nII. To determine efficacy with respect to the proportion of subjects that achieve a >= 50% reduction in prostate-specific antigen (PSA) at 12 weeks. (Phase II)\n\nSECONDARY OBJECTIVES:\n\nI. PSA progression-free survival.\n\nII. Radiographic progression-free survival.\n\nIII. Safety.\n\nIV. Pharmacokinetics.\n\nTERTIARY OBJECTIVES:\n\nI. To evaluate the expression of retinoblastoma (RB) in circulating tumor cells (CTCs) and tumor tissue.\n\nII. To evaluate other mechanisms of castrate resistance (such as androgen receptor [AR]-variant [v]7) in tumor tissue and CTCs.\n\nIII. To explore resistance mechanisms of cyclin dependent kinase (CDK)4/6 inhibitors in tumor samples in patients that progress on enzalutamide and ribociclib.\n\nIV. Explore the use/correlation of circulating deoxyribonucleic acid (DNA)/exosomes in castrate-resistant prostate cancer (CRPC) patients treated with enzalutamide with and without ribociclib.\n\nV. Androgen profiles and correlation to clinical outcomes. VI. Development of model explant systems to correlate with the clinical outcome.\n\nOUTLINE: This is a phase I, dose-escalation study of ribociclib followed by a phase II study.\n\nPHASE Ib: Patients receive enzalutamide orally (PO) once daily (QD) on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPHASE II: Patients are randomized to 1 of 2 treatment arms.\n\nARM A: Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients receive enzalutamide PO QD on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months for 24 months.', 'Inclusion Criteria': "Inclusion Criteria:\n\nWilling and able to provide written informed consent and HIPAA authorization for the release of personal health information. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. Consent and HIPPA authorization must be obtained prior to any screening procedures.\nMales 18 years of age and above\nHistological or cytological proof of prostate cancer\nDocumented progressive mCRPC based on at least one of the following criteria:\n\nPSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.\nSoft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.\nProgression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan.\n7) Have testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy 8) ECOG performance status of 0-1 9) Patients on long term (>6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen. Patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to enrollment (no wash out period required).\n\n10) Patient has adequate bone marrow and organ function as defined by the following laboratory values:\n\nAbsolute neutrophil count ≥ 1.5 × 109/L.\nPlatelets (UNVPLT) ≥ 100 × 109/L.\nHemoglobin (HGB) ≥ 9 g/dl.\nPotassium (K), total calcium (CA)(corrected for serum albumin), magnesium, sodium (NA) and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication.\nINR ≤ 1.5.\nSerum creatinine (CREAT) ≤ 1.5 mg/dL or creatine clearance > 50 mL/min.\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN. If the patient has liver metastases, ALT and AST must still be ≤ 2.5 x ULN. Patients with liver metastases and AST/ALT above this limit will not be enrolled..\nTotal serum bilirubin ≤ 1.5 x ULN; or total bilirubin (TBILI) ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome.\n\n11) The effects of ribociclib on the developing human fetus at the recommended therapeutic dose are unknown. Men must agree to use adequate contraception prior to enrollment, for the duration of study participation and for at least 3 months thereafter.\n\n12) Must be able to take oral medication without crushing, dissolving or chewing tablets."}

{'Arm - Disease - Indication': 'RB Expression Retaining Metastatic Castrate Resistant Chemotherapy-Naive Prostate Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02555189

{'Official Title': 'Randomized Phase IB/II Study of Enzalutamide With and Without Ribociclib in Patients With Metastatic Castrate Resistant, Chemotherapy Naïve Prostate Cancer That Retains RB Expression\n', 'Brief Summary': 'This partially randomized phase IB/II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with prostate cancer that does not respond to treatment with hormones (hormone resistant), has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naïve, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer.\n', 'Condition': 'Hormone-Resistant Prostate Cancer\nMetastatic Prostate Carcinoma\nProstate Carcinoma Metastatic in the Bone\nStage IV Prostate Cancer', 'Detailed Description': 'PRIMARY OBJECTIVES:\n\nI. To determine the maximum tolerated dose of ribociclib in combination with 160 mg of enzalutamide. (Phase Ib)\n\nII. To determine efficacy with respect to the proportion of subjects that achieve a >= 50% reduction in prostate-specific antigen (PSA) at 12 weeks. (Phase II)\n\nSECONDARY OBJECTIVES:\n\nI. PSA progression-free survival.\n\nII. Radiographic progression-free survival.\n\nIII. Safety.\n\nIV. Pharmacokinetics.\n\nTERTIARY OBJECTIVES:\n\nI. To evaluate the expression of retinoblastoma (RB) in circulating tumor cells (CTCs) and tumor tissue.\n\nII. To evaluate other mechanisms of castrate resistance (such as androgen receptor [AR]-variant [v]7) in tumor tissue and CTCs.\n\nIII. To explore resistance mechanisms of cyclin dependent kinase (CDK)4/6 inhibitors in tumor samples in patients that progress on enzalutamide and ribociclib.\n\nIV. Explore the use/correlation of circulating deoxyribonucleic acid (DNA)/exosomes in castrate-resistant prostate cancer (CRPC) patients treated with enzalutamide with and without ribociclib.\n\nV. Androgen profiles and correlation to clinical outcomes. VI. Development of model explant systems to correlate with the clinical outcome.\n\nOUTLINE: This is a phase I, dose-escalation study of ribociclib followed by a phase II study.\n\nPHASE Ib: Patients receive enzalutamide orally (PO) once daily (QD) on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPHASE II: Patients are randomized to 1 of 2 treatment arms.\n\nARM A: Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients receive enzalutamide PO QD on days 1-28 and ribociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months for 24 months.', 'Inclusion Criteria': "Inclusion Criteria:\n\nWilling and able to provide written informed consent and HIPAA authorization for the release of personal health information. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. Consent and HIPPA authorization must be obtained prior to any screening procedures.\nMales 18 years of age and above\nHistological or cytological proof of prostate cancer\nDocumented progressive mCRPC based on at least one of the following criteria:\n\nPSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.\nSoft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.\nProgression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan.\n7) Have testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy 8) ECOG performance status of 0-1 9) Patients on long term (>6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen. Patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to enrollment (no wash out period required).\n\n10) Patient has adequate bone marrow and organ function as defined by the following laboratory values:\n\nAbsolute neutrophil count ≥ 1.5 × 109/L.\nPlatelets (UNVPLT) ≥ 100 × 109/L.\nHemoglobin (HGB) ≥ 9 g/dl.\nPotassium (K), total calcium (CA)(corrected for serum albumin), magnesium, sodium (NA) and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication.\nINR ≤ 1.5.\nSerum creatinine (CREAT) ≤ 1.5 mg/dL or creatine clearance > 50 mL/min.\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN. If the patient has liver metastases, ALT and AST must still be ≤ 2.5 x ULN. Patients with liver metastases and AST/ALT above this limit will not be enrolled..\nTotal serum bilirubin ≤ 1.5 x ULN; or total bilirubin (TBILI) ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome.\n\n11) The effects of ribociclib on the developing human fetus at the recommended therapeutic dose are unknown. Men must agree to use adequate contraception prior to enrollment, for the duration of study participation and for at least 3 months thereafter.\n\n12) Must be able to take oral medication without crushing, dissolving or chewing tablets."}

{'Arm - Disease - Indication': 'RB Expression Retaining Metastatic Castrate Resistant Chemotherapy-Naive Prostate Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03647969

{'Official Title': 'Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm.\r\n\r\nPatients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg "Flatdose" i.v. d1 every 2 weeks) and Ipilimumab (1mg/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg "Flatdose" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks).\r\n\r\nTreatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment.\r\n\r\nThe primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1).\r\n\r\nSecondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis.\r\n\r\n257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAll subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma.\r\nSubjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour.\r\nSubject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.\r\nPrior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization/enrolment.\r\nPalliative radiotherapy is allowed and must be completed 2 weeks prior to randomization/enrolment.\r\nSubjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D).\r\nECOG performance status score of 0 or 1 (Appendix B).\r\nLife expectancy > 12 weeks\r\nScreening laboratory values must meet the following criteria (using NCI CTCAE v.4.03):\r\n\r\nWBC ≥ 2000/uL\r\nNeutrophils ≥ 1500/µL\r\nPlatelets ≥ 100x10^3/µL\r\nHemoglobin ≥ 9.0 g/dL\r\nSerum creatinine ≤ 1.5 x ULN\r\nAST ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nALT ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nTotal Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN)\r\nMales and Females* ≥ 18 years of age\r\n\r\n*There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently.\r\n\r\nSubjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\r\nSubjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\r\nWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding.\r\nWOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug.\r\nMales who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.'}

{'Arm - Disease - Indication': 'Previously Untreated HER2-negative Advanced or Metastatic Esophagogastric Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03647969

{'Official Title': 'Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm.\r\n\r\nPatients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg "Flatdose" i.v. d1 every 2 weeks) and Ipilimumab (1mg/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg "Flatdose" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks).\r\n\r\nTreatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment.\r\n\r\nThe primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1).\r\n\r\nSecondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis.\r\n\r\n257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAll subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma.\r\nSubjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour.\r\nSubject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.\r\nPrior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization/enrolment.\r\nPalliative radiotherapy is allowed and must be completed 2 weeks prior to randomization/enrolment.\r\nSubjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D).\r\nECOG performance status score of 0 or 1 (Appendix B).\r\nLife expectancy > 12 weeks\r\nScreening laboratory values must meet the following criteria (using NCI CTCAE v.4.03):\r\n\r\nWBC ≥ 2000/uL\r\nNeutrophils ≥ 1500/µL\r\nPlatelets ≥ 100x10^3/µL\r\nHemoglobin ≥ 9.0 g/dL\r\nSerum creatinine ≤ 1.5 x ULN\r\nAST ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nALT ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nTotal Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN)\r\nMales and Females* ≥ 18 years of age\r\n\r\n*There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently.\r\n\r\nSubjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\r\nSubjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\r\nWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding.\r\nWOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug.\r\nMales who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.'}

{'Arm - Disease - Indication': 'Previously Untreated HER2-negative Advanced or Metastatic Esophagogastric Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03647969

{'Official Title': 'Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm.\r\n\r\nPatients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg "Flatdose" i.v. d1 every 2 weeks) and Ipilimumab (1mg/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg "Flatdose" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks).\r\n\r\nTreatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment.\r\n\r\nThe primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1).\r\n\r\nSecondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis.\r\n\r\n257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAll subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma.\r\nSubjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour.\r\nSubject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.\r\nPrior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization/enrolment.\r\nPalliative radiotherapy is allowed and must be completed 2 weeks prior to randomization/enrolment.\r\nSubjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D).\r\nECOG performance status score of 0 or 1 (Appendix B).\r\nLife expectancy > 12 weeks\r\nScreening laboratory values must meet the following criteria (using NCI CTCAE v.4.03):\r\n\r\nWBC ≥ 2000/uL\r\nNeutrophils ≥ 1500/µL\r\nPlatelets ≥ 100x10^3/µL\r\nHemoglobin ≥ 9.0 g/dL\r\nSerum creatinine ≤ 1.5 x ULN\r\nAST ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nALT ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nTotal Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN)\r\nMales and Females* ≥ 18 years of age\r\n\r\n*There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently.\r\n\r\nSubjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\r\nSubjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\r\nWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding.\r\nWOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug.\r\nMales who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.'}

{'Arm - Disease - Indication': 'Previously Untreated HER2-negative Advanced or Metastatic Esophagogastric Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03647969

{'Official Title': 'Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.', 'Brief Summary': 'Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.', 'Condition': 'Adenocarcinoma of the Stomach, GastroEsophageal Cancer', 'Detailed Description': 'This is a randomized, open labelled multicenter phase II trial, followed by a non-randomized arm.\r\n\r\nPatients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be randomized to receive either modified FOLFOX (Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2), every 2 weeks) alone, modified FOLFOX plus Nivolumab (240mg "Flatdose" i.v. d1 every 2 weeks) and Ipilimumab (1mg/kg i.v. d1 every 6 weeks) or sequential treatment (three cycles of induction chemotherapy with modified FOLFOX followed by immunotherapy consisting of 4 administrations of Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and 2 administrations of Ipilimumab at 1mg/kg i.v. d1 every 6 weeks, this sequence may be repeated starting two weeks after last administration of immunotherapy once, or, if medically reasonable, for an unlimited number of repetitions upon investigator decision; after completion or discontinuation of chemotherapy, immunotherapy will be continued consisting of Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks and Ipilimumab at 1mg/kg i.v. d1 every 6 weeks). In a non-randomized arm, patients receive Nivolumab 240mg "Flatdose" i.v. d1 every 2 weeks and FLOT (Docetaxel 50mg/², Oxaliplatin 85 mg/m², leucovorin 200 mg/m² on day 1 and fluorouracil 2600 mg/m² IV continuous infusion over 24 hours) every 2 weeks. After completion or discontinuation of chemotherapy, immunotherapy may be continued (Nivolumab at 240mg "Flatdose" i.v. d1 every 2 weeks).\r\n\r\nTreatment in every arm will be given for a maximum of 24 months or until disease progression or inacceptable toxicity or end of study treatment.\r\n\r\nThe primary objective is to determine the clinical performance of the experimental regimen in patients with previously untreated HER2 negative locally advanced or metastatic esophagogastric adenocarcinoma in terms of progression free survival (acc. to RECIST v1.1).\r\n\r\nSecondary objectives are to determine efficacy in terms of objective response rate (acc. to RECIST v1.1) and overall survival, as well as tolerability (acc. to NCI CTC AE v4.03) of the experimental regimen. In addition histopathological types and molecular parameters such as immune cell composition and PD-L1 expression as determined by quantitative mRNA (RT-PCR) will be correlated with efficacy in an exploratory analysis.\r\n\r\n257 subjects (59 in the control arm, 89 in the experimental treatment group A1, 59 in the experimental treatment group A2 and 50 in the experimental treatment group C) will be enrolled.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nAll subjects must have inoperable, advanced or metastatic GC or GEJ adenocarcinoma.\r\nSubjects must have HER2-negative disease defined as either IHC 0 or I+ or IHC 2+, the latter in combination with ISH-, as assessed locally on a primary or metastatic tumour.\r\nSubject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.\r\nPrior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy are permitted as long as the last administration of the last regimen (whichever was given last) occurred at least 6 months prior to randomization/enrolment.\r\nPalliative radiotherapy is allowed and must be completed 2 weeks prior to randomization/enrolment.\r\nSubjects must have measurable or evaluable non-measurable disease as assessed by the investigator, according to RECIST v1.1 (Appendix D).\r\nECOG performance status score of 0 or 1 (Appendix B).\r\nLife expectancy > 12 weeks\r\nScreening laboratory values must meet the following criteria (using NCI CTCAE v.4.03):\r\n\r\nWBC ≥ 2000/uL\r\nNeutrophils ≥ 1500/µL\r\nPlatelets ≥ 100x10^3/µL\r\nHemoglobin ≥ 9.0 g/dL\r\nSerum creatinine ≤ 1.5 x ULN\r\nAST ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nALT ≤ 3.0 x ULN (or ≤ 5.0X ULN if liver metastates are present)\r\nTotal Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN)\r\nMales and Females* ≥ 18 years of age\r\n\r\n*There are no data that indicate special gender distribution. Therefore patients will be enrolled in the study gender-independently.\r\n\r\nSubjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\r\nSubjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\r\nWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women must not be breastfeeding.\r\nWOCBP must agree to follow instructions for method(s) of contraception for a period of 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. WOCBP should use an adequate method to avoid pregnancy for approximately 5 months (30 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug.\r\nMales who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a period of 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo 5 half-lives. The terminal half-lives of nivolumab and ipilimumab are approximately 25 days and 15 days, respectively. Males who are sexually active with WOCBP must continue contraception for approximately 7 months (90 days plus the time required for nivolumab to undergo 5 half-lives) after the last dose of investigational drug. In addition, male subjects must be willing to refrain from sperm donation during this time.'}

{'Arm - Disease - Indication': 'Previously Untreated HER2-negative Advanced or Metastatic Esophagogastric Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02824458

{'Official Title': 'A Multicenter, Randomized,Double-Blind Study of Gefitinib in Combination With Apatinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-squamous Non-Small-Cell Lung Cancer', 'Brief Summary': 'The main purpose of this study is to evaluate the safety and efficacy of Apatinib in combination with Gefitinib as compared to placebo in combination with Gefitinib in participants with stage ⅢB-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).', 'Condition': 'Non-Small-Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n≥ 18 and ≤ 70 years of age\r\nEastern Cooperative Oncology Group(ECOG)performance scale 0 - 1.\r\nLife expectancy of more than 3 weeks.\r\nHistologically or cytologic confirmed，locally advanced and/or metastatic non-squamous NSCLC of stage IIIB (unsuitable for radiotherapy) or IV or recurrent NSCLC; At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy or cryotherapy.\r\nDocumented evidence of tumor harboring an activating EGFR mutation (Example 19 del and L858R) .\r\nNone previous chemotherapy or targeted therapy. NOTE: neoadjuvant and/or adjuvant therapy is allowed which is completed before 6 months.\r\nPrior radiation therapy is allowed if: 25% or less of total bone marrow had been irradiated,pelvis and chest had not been irradiated; at least 4 weeks have elapsed from the completion of radiation treatment, and the acute toxicity from radiation treatment had been recover; irradiated lesion is not including measurable lesions unless documented progress after radiation.\r\nAdequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 100×109/L, Hemoglobin(HB) ≥ 100 g/L, total bilirubin within 1.5×the upper limit of normal(ULN), and serum transaminase≤2.5×the Upper Limit Of Normal(ULN), serum creatine ≤ 1 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥ 50ml/min,\r\nFor women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.\r\nSigned and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.'}

{'Arm - Disease - Indication': 'Previously Untreated EGFR Mutated Stage IIIB-Stage IV Advanced Stage ⅢB-IV , Advanced, Locally Advanced, Metastatic Non-squamous Non-small-cell Lung Cancer '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT02824458

{'Official Title': 'A Multicenter, Randomized,Double-Blind Study of Gefitinib in Combination With Apatinib or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Advanced Non-squamous Non-Small-Cell Lung Cancer', 'Brief Summary': 'The main purpose of this study is to evaluate the safety and efficacy of Apatinib in combination with Gefitinib as compared to placebo in combination with Gefitinib in participants with stage ⅢB-IV Non-squamous non-small-cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of Apatinib in combination with Gefitinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).', 'Condition': 'Non-Small-Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\n≥ 18 and ≤ 70 years of age\r\nEastern Cooperative Oncology Group(ECOG)performance scale 0 - 1.\r\nLife expectancy of more than 3 weeks.\r\nHistologically or cytologic confirmed，locally advanced and/or metastatic non-squamous NSCLC of stage IIIB (unsuitable for radiotherapy) or IV or recurrent NSCLC; At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy or cryotherapy.\r\nDocumented evidence of tumor harboring an activating EGFR mutation (Example 19 del and L858R) .\r\nNone previous chemotherapy or targeted therapy. NOTE: neoadjuvant and/or adjuvant therapy is allowed which is completed before 6 months.\r\nPrior radiation therapy is allowed if: 25% or less of total bone marrow had been irradiated,pelvis and chest had not been irradiated; at least 4 weeks have elapsed from the completion of radiation treatment, and the acute toxicity from radiation treatment had been recover; irradiated lesion is not including measurable lesions unless documented progress after radiation.\r\nAdequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 100×109/L, Hemoglobin(HB) ≥ 100 g/L, total bilirubin within 1.5×the upper limit of normal(ULN), and serum transaminase≤2.5×the Upper Limit Of Normal(ULN), serum creatine ≤ 1 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥ 50ml/min,\r\nFor women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.\r\nSigned and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.'}

{'Arm - Disease - Indication': 'Previously Untreated EGFR Mutated Stage IIIB-Stage IV Advanced Stage ⅢB-IV , Advanced, Locally Advanced, Metastatic Non-squamous Non-small-cell Lung Cancer '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05214222

{'Official Title': 'Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With Advanced Esophageal Squamous Cell Carcinoma (Answer): A Randomized Two-arm Clinical Study', 'Brief Summary': 'Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study', 'Condition': 'Essential Tremor', 'Detailed Description': 'This is a open-label, phase II study of Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy in subjects With resectable advanced esophageal squamous cell carcinoma. The patients will be divided into two groups. In group A, Penpulimab plus chemotherapy with Anlotinib will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Anlotinib and Penpulimab will be used every 3 weeks until disease progression or intolerance; In group B, Penpulimab plus chemotherapy will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Penpulimab will be used every 3 weeks until disease progression or intolerance;', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients with advanced metastatic esophageal squamous cell carcinoma who cannot receive radical treatment (excluding mixed adenosquamous carcinoma);\r\nThose who have not received systemic treatment in the past, or (new) adjuvant treatment/radical surgery/radical radiotherapy and chemotherapy have relapsed for more than 6 months; Note: Including patients with advanced or recurring non-target lesions who have progressed again after radiotherapy alone. For local lesions (non-target lesions), the time from the end of palliative treatment to the enrollment time> 2 weeks;\r\nAccording to the RECIST 1.1 version of the curative effect evaluation standard for solid tumors, there is at least one measurable lesion; the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area, if it is confirmed that it has progressed, and meets RECIST1.1 Standard, target lesions can also be selected);\r\nPatients between 18 and 75 years old;\r\nECOGPS score: 0~1 points; the expected survival period is more than 3 months;\r\nTumor specimens can be provided to determine gene detection and PD-L1 expression, at least 15 white sheets (assessed by the company); provide two oral swabs; within 7 days before the medication, the first, third, and sixth at the end of the cycle, one tube of 6ml EDTA anticoagulant blood will be provided.\r\nIt has sufficient organ and bone marrow function, that is, it meets the following standards:\r\n(1) The standard of routine blood examination must meet: Hemoglobin content (HB) ≥90g/L (no blood transfusion within 28 days); Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count (PLT) ≥100×109/L. (2) The biochemical inspection shall meet the following standards: Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); ALT and AST≤2.5´ULN; if there is liver metastasis, ALT and AST≤5´ULN; Cr≤1.5´ULN or creatinine clearance (CCr)≥60ml/min; (Cockcroft-Gault formula) (3) The coagulation function is adequate, which is defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8) Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the treatment, and they must be non-lactating patients. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:\r\n\r\nPost-menopausal is defined as amenorrhea at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped;\r\nFor women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference value range, also Can be considered post-menopausal;\r\nHave received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral tubal ligation.\r\nFor men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 9) The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.'}

{'Arm - Disease - Indication': 'First-Line Resectable Advanced Metastatic Esophageal Squamous Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05214222

{'Official Title': 'Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With Advanced Esophageal Squamous Cell Carcinoma (Answer): A Randomized Two-arm Clinical Study', 'Brief Summary': 'Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study', 'Condition': 'Essential Tremor', 'Detailed Description': 'This is a open-label, phase II study of Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy in subjects With resectable advanced esophageal squamous cell carcinoma. The patients will be divided into two groups. In group A, Penpulimab plus chemotherapy with Anlotinib will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Anlotinib and Penpulimab will be used every 3 weeks until disease progression or intolerance; In group B, Penpulimab plus chemotherapy will be given every 3 weeks for 4-6 cycles in initial stage, then in maintenance treatment, Penpulimab will be used every 3 weeks until disease progression or intolerance;', 'Inclusion Criteria': 'Inclusion Criteria:\n\nPatients with advanced metastatic esophageal squamous cell carcinoma who cannot receive radical treatment (excluding mixed adenosquamous carcinoma);\nThose who have not received systemic treatment in the past, or (new) adjuvant treatment/radical surgery/radical radiotherapy and chemotherapy have relapsed for more than 6 months; Note: Including patients with advanced or recurring non-target lesions who have progressed again after radiotherapy alone. For local lesions (non-target lesions), the time from the end of palliative treatment to the enrollment time> 2 weeks;\nAccording to the RECIST 1.1 version of the curative effect evaluation standard for solid tumors, there is at least one measurable lesion; the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area, if it is confirmed that it has progressed, and meets RECIST1.1 Standard, target lesions can also be selected);\nPatients between 18 and 75 years old;\nECOGPS score: 0~1 points; the expected survival period is more than 3 months;\nTumor specimens can be provided to determine gene detection and PD-L1 expression, at least 15 white sheets (assessed by the company); provide two oral swabs; within 7 days before the medication, the first, third, and sixth at the end of the cycle, one tube of 6ml EDTA anticoagulant blood will be provided.\nIt has sufficient organ and bone marrow function, that is, it meets the following standards:\n(1) The standard of routine blood examination must meet: Hemoglobin content (HB) ≥90g/L (no blood transfusion within 28 days); Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count (PLT) ≥100×109/L. (2) The biochemical inspection shall meet the following standards: Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); ALT and AST≤2.5´ULN; if there is liver metastasis, ALT and AST≤5´ULN; Cr≤1.5´ULN or creatinine clearance (CCr)≥60ml/min; (Cockcroft-Gault formula) (3) The coagulation function is adequate, which is defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8) Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the treatment, and they must be non-lactating patients. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:\n\nPost-menopausal is defined as amenorrhea at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped;\nFor women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference value range, also Can be considered post-menopausal;\nHave received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral tubal ligation.\nFor men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 9) The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.'}

{'Arm - Disease - Indication': 'First-Line Resectable Advanced Metastatic Esophageal Squamous Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05842317

{'Official Title': 'A Randomized, Controlled, Single-center Clinical Study of Lenvatinib in Combination With Tislelizumab With or Without TACE in First-line Treatment of Advanced Hepatocellular Carcinoma.', 'Brief Summary': 'To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety', 'Condition': 'Hepatocellular Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nParticipants must meet all of the following criteria to be included:\r\nParticipants must voluntarily agree to participate in the study and provide written informed consent, be compliant, and agree to follow-up.\r\nParticipants must be between 18 and 80 years old, regardless of gender, at the time of signing the informed consent form.\r\nParticipants must be diagnosed with hepatocellular carcinoma by imaging (according to AASLD criteria or the 2022 National Health Commission Guidelines for the Diagnosis and Treatment of Liver Cancer) or histological or cytological examination.\r\nPatients with advanced liver cancer: patients who are in BCLC stage C or B and are eligible for TACE treatment.\r\nParticipants must not have received systemic treatment.\r\nThere must be at least one measurable lesion (according to RECIST 1.1 criteria, the measurable lesion must have a spiral CT scan long diameter ≥10 mm or an enlarged lymph node short diameter ≥15 mm).\r\nECOG performance status must be 0-1 point within 1 week before enrollment.\r\nChild-Pugh liver function grade: Class A (5-6 points).\r\nExpected survival time ≥3 months.\r\nActive hepatitis B or C patients must receive relevant antiviral treatment, with HBV-DNA <2500 IU/mL (<105 copies/mL) and have received antiviral treatment for at least 14 days before participating in the study. HCV RNA-positive patients must be treated according to local standard treatment guidelines and have liver function increased no more than Grade 1 in CTCAE during treatment.\r\nHematological and organ function must be adequate, based on laboratory test results obtained within 14 days before starting the study treatment, unless otherwise specified:\r\nComplete blood count: (not transfused, not treated with G-CSF or drugs for correction) white blood cell count ≥ 3.0 x 109/L, Hb ≥ 90 g/L, neutrophil count ≥ 1.5 × 109/L, and platelet count ≥ 60 × 109/L.\r\n\r\nBiochemical tests: (not given albumin in the last 14 days)\r\nAppropriate liver function: ALB ≥ 29 g/L, ALP, ALT, and AST <5 × ULN, TBIL ≤ 3 × ULN, and PT prolongation time no more than 6s of ULN\r\nAppropriate renal function: Creatinine ≤ 1.5 × ULN, or creatinine clearance (CCr) >50 mL/min (using the Cockcroft-Gault formula):\r\nFemale: CrCl = ((140 - age) × body weight (kg) × 0.85) / 72 × serum creatinine (mg/dL) Male: CrCl = ((140 - age) × body weight (kg) × 1.00) / 72 × serum creatinine (mg/dL)\r\n\r\n• Women of childbearing potential: must agree to abstain from sexual activity or use a contraceptive method with a failure rate of less than 1% for at least 6 months during the treatment period and after the last dose.\r\n\r\nIf a female patient has menstruated and has not yet reached postmenopausal status (no menstrual periods for ≥12 months continuously, and no other causes for menopause except surgical sterilization), and has not undergone sterilization surgery (removal of the ovaries and/or uterus), she is considered to be of childbearing potential.'}

{'Arm - Disease - Indication': 'First-line Advanced Hepatocellular Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05842317

{'Official Title': 'A Randomized, Controlled, Single-center Clinical Study of Lenvatinib in Combination With Tislelizumab With or Without TACE in First-line Treatment of Advanced Hepatocellular Carcinoma.', 'Brief Summary': 'To explore the effects of lenvatinib in combination with tislelizumab with or without TACE in patients with hepatocellular carcinoma on survival, disease progression, and medication safety', 'Condition': 'Hepatocellular Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be included:\nParticipants must voluntarily agree to participate in the study and provide written informed consent, be compliant, and agree to follow-up.\nParticipants must be between 18 and 80 years old, regardless of gender, at the time of signing the informed consent form.\nParticipants must be diagnosed with hepatocellular carcinoma by imaging (according to AASLD criteria or the 2022 National Health Commission Guidelines for the Diagnosis and Treatment of Liver Cancer) or histological or cytological examination.\nPatients with advanced liver cancer: patients who are in BCLC stage C or B and are eligible for TACE treatment.\nParticipants must not have received systemic treatment.\nThere must be at least one measurable lesion (according to RECIST 1.1 criteria, the measurable lesion must have a spiral CT scan long diameter ≥10 mm or an enlarged lymph node short diameter ≥15 mm).\nECOG performance status must be 0-1 point within 1 week before enrollment.\nChild-Pugh liver function grade: Class A (5-6 points).\nExpected survival time ≥3 months.\nActive hepatitis B or C patients must receive relevant antiviral treatment, with HBV-DNA <2500 IU/mL (<105 copies/mL) and have received antiviral treatment for at least 14 days before participating in the study. HCV RNA-positive patients must be treated according to local standard treatment guidelines and have liver function increased no more than Grade 1 in CTCAE during treatment.\nHematological and organ function must be adequate, based on laboratory test results obtained within 14 days before starting the study treatment, unless otherwise specified:\nComplete blood count: (not transfused, not treated with G-CSF or drugs for correction) white blood cell count ≥ 3.0 x 109/L, Hb ≥ 90 g/L, neutrophil count ≥ 1.5 × 109/L, and platelet count ≥ 60 × 109/L.\n\nBiochemical tests: (not given albumin in the last 14 days)\nAppropriate liver function: ALB ≥ 29 g/L, ALP, ALT, and AST <5 × ULN, TBIL ≤ 3 × ULN, and PT prolongation time no more than 6s of ULN\nAppropriate renal function: Creatinine ≤ 1.5 × ULN, or creatinine clearance (CCr) >50 mL/min (using the Cockcroft-Gault formula):\nFemale: CrCl = ((140 - age) × body weight (kg) × 0.85) / 72 × serum creatinine (mg/dL) Male: CrCl = ((140 - age) × body weight (kg) × 1.00) / 72 × serum creatinine (mg/dL)\n\n• Women of childbearing potential: must agree to abstain from sexual activity or use a contraceptive method with a failure rate of less than 1% for at least 6 months during the treatment period and after the last dose.\n\nIf a female patient has menstruated and has not yet reached postmenopausal status (no menstrual periods for ≥12 months continuously, and no other causes for menopause except surgical sterilization), and has not undergone sterilization surgery (removal of the ovaries and/or uterus), she is considered to be of childbearing potential.'}

{'Arm - Disease - Indication': 'First-line Advanced Hepatocellular Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05163249

{'Official Title': 'A Prospective, Pilot Study of First-line Osimertinib With or Without Savolitinib in de Novo MET Positive, EGFR-mutant NSCLCs (FLOWERS)\n', 'Brief Summary': 'This is a prospective, pilot, two-arm, randomized, multicenter study exploring the efficacy and safety of osimertinib with or without savolitinib as first-line therapy in patients with de novo MET positive, EGFR-mutant advanced NSCLC.\n', 'Condition': 'Carcinoma, Non-Small-Cell Lung', 'Detailed Description': 'Approximately 44 eligible patients will be enrolled to randomly assigned to study interventions so that approximately 40 evaluable participants complete the study, based on an assumption of 10% of participants not completing the study.\n\nAll eligible patients will be randomized in a 1:1 ratio to receive treatment with osimertinib (80 mg daily) or osimertinib (80 mg daily) in combination with savolitinib (300 mg BID) in this study. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.\n\nPatients who progress on first-line treatment of osimertinib monotherapy will have the opportunity to receive second-line treatment of osimertinib plus savolitinib after confirmation of MET status at disease progression.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nInformed consent\n\nCapable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\nProvision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.\n\nAge\n\nParticipant must be ≥18 years at the time of signing the ICF. All genders are permitted.\n\nType of Participant and Disease Characteristics\n\nHistologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity.\nHas not received any systemic treatment of advanced NSCLC.\n\nPrior adjuvant/neo-adjuvant therapy completed > 6 months before screening is allowed.\nMET amplification/high expression as determined by FISH, IHC or NGS testing on tumor tissue collected before any systemic treatment in first line.\n\nMET high expression by IHC, 3+ in ≥75% of tumor cells\nincreased MET gene copy number by FISH, MET gene copy ≥5 or MET / CEP7 ratio ≥2; or by tissue NGS, ≥20% tumour cells, ≥200x sequencing depth of coverage and CN ≥5.\nLocal IHC, FISH and pre-existing local NGS results are acceptable, central FISH and central NGS confirmation is highly suggested if tissue sample available.\nWHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing and a minimum life expectancy of 12 weeks.\nAt least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\nAdequate haematological function defined as:\n\nHaemoglobin≥8.5 g/dL (no transfusion in the past 2 weeks).\nAbsolute neutrophil count ≥1.5×109/L.\nPlatelet count ≥100,000/μL (no transfusion in the past 10 days)\nAdequate liver function defined as:\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN) with total bilirubin (TBL) ≤ ULN\nOR TBL >ULN to ≤1.5x ULN with ALT and AST ≤ ULN\nAdequate renal function defined as a creatinine <1.5 times the institutional ULN OR a glomerular filtration rate ≥50 mL/min, as assessed using the standard methodology at the investigating centre (eg, Cockcroft-Gault, Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration formulae, ethylenediaminetetraacetic acid clearance or 24-hour urine collection). Confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.\nAdequate coagulation parameters, defined as:\n\nInternational Normalisation Ratio (INR) <1.5 x ULN and activated partial thromboplastin time <1.5 x ULN unless patients are receiving therapeutic anti coagulation which affects these parameters.\nPatients with known tumor thrombus or deep vein thrombosis are eligible if clinically stable on low molecular weight heparin (LMWH) for ≥2 weeks.\nAbility to swallow and retain oral medications.\nWillingness and ability to comply with study and follow-up procedures.\n\nReproduction\n\nFemales must be using highly effective contraceptive measures (see Section 5.3.2), and have a negative pregnancy test (serum) for women of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:\n\nPost-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\nWomen under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.\nWomen with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\nFurther information is available in Appendix F (Contraception Requirements).\nMale patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.'}

{'Arm - Disease - Indication': 'De Novo MET Positive EGFR Mutant Advanced Locally Advanced or Metastatic Non Small Cell Lung Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05163249

{'Official Title': 'A Prospective, Pilot Study of First-line Osimertinib With or Without Savolitinib in de Novo MET Positive, EGFR-mutant NSCLCs (FLOWERS)\n', 'Brief Summary': 'This is a prospective, pilot, two-arm, randomized, multicenter study exploring the efficacy and safety of osimertinib with or without savolitinib as first-line therapy in patients with de novo MET positive, EGFR-mutant advanced NSCLC.\n', 'Condition': 'Carcinoma, Non-Small-Cell Lung', 'Detailed Description': 'Approximately 44 eligible patients will be enrolled to randomly assigned to study interventions so that approximately 40 evaluable participants complete the study, based on an assumption of 10% of participants not completing the study.\n\nAll eligible patients will be randomized in a 1:1 ratio to receive treatment with osimertinib (80 mg daily) or osimertinib (80 mg daily) in combination with savolitinib (300 mg BID) in this study. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.\n\nPatients who progress on first-line treatment of osimertinib monotherapy will have the opportunity to receive second-line treatment of osimertinib plus savolitinib after confirmation of MET status at disease progression.', 'Inclusion Criteria': 'Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nInformed consent\n\nCapable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\nProvision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.\n\nAge\n\nParticipant must be ≥18 years at the time of signing the ICF. All genders are permitted.\n\nType of Participant and Disease Characteristics\n\nHistologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity.\nHas not received any systemic treatment of advanced NSCLC.\n\nPrior adjuvant/neo-adjuvant therapy completed > 6 months before screening is allowed.\nMET amplification/high expression as determined by FISH, IHC or NGS testing on tumor tissue collected before any systemic treatment in first line.\n\nMET high expression by IHC, 3+ in ≥75% of tumor cells\nincreased MET gene copy number by FISH, MET gene copy ≥5 or MET / CEP7 ratio ≥2; or by tissue NGS, ≥20% tumour cells, ≥200x sequencing depth of coverage and CN ≥5.\nLocal IHC, FISH and pre-existing local NGS results are acceptable, central FISH and central NGS confirmation is highly suggested if tissue sample available.\nWHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing and a minimum life expectancy of 12 weeks.\nAt least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\nAdequate haematological function defined as:\n\nHaemoglobin≥8.5 g/dL (no transfusion in the past 2 weeks).\nAbsolute neutrophil count ≥1.5×109/L.\nPlatelet count ≥100,000/μL (no transfusion in the past 10 days)\nAdequate liver function defined as:\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN) with total bilirubin (TBL) ≤ ULN\nOR TBL >ULN to ≤1.5x ULN with ALT and AST ≤ ULN\nAdequate renal function defined as a creatinine <1.5 times the institutional ULN OR a glomerular filtration rate ≥50 mL/min, as assessed using the standard methodology at the investigating centre (eg, Cockcroft-Gault, Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration formulae, ethylenediaminetetraacetic acid clearance or 24-hour urine collection). Confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN.\nAdequate coagulation parameters, defined as:\n\nInternational Normalisation Ratio (INR) <1.5 x ULN and activated partial thromboplastin time <1.5 x ULN unless patients are receiving therapeutic anti coagulation which affects these parameters.\nPatients with known tumor thrombus or deep vein thrombosis are eligible if clinically stable on low molecular weight heparin (LMWH) for ≥2 weeks.\nAbility to swallow and retain oral medications.\nWillingness and ability to comply with study and follow-up procedures.\n\nReproduction\n\nFemales must be using highly effective contraceptive measures (see Section 5.3.2), and have a negative pregnancy test (serum) for women of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:\n\nPost-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\nWomen under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.\nWomen with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\nFurther information is available in Appendix F (Contraception Requirements).\nMale patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.'}

{'Arm - Disease - Indication': 'De Novo MET Positive EGFR Mutant Advanced Locally Advanced or Metastatic Non Small Cell Lung Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03675737

{'Official Title': 'A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).', 'Condition': 'Stomach Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status\nHas human epidermal growth factor receptor 2 (HER2) negative cancer\nMale Participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy refrain from donating sperm and be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period\nFemale Participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period\nHas measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated\nHas provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis\nHas provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention\nHas adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment'}

{'Arm - Disease - Indication': 'Adult First-Line HER2 Negative Previously Untreated Locally Advanced Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03675737

{'Official Title': 'A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants.\r\n\r\nThe primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).', 'Condition': 'Stomach Neoplasms', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status\nHas human epidermal growth factor receptor 2 (HER2) negative cancer\nMale Participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy refrain from donating sperm and be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period\nFemale Participants who are not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) OR is a WOCBP who agrees to use contraception or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is last, and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period\nHas measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator assessment\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated\nHas provided tumor tissue sample deemed adequate for PD-L1 biomarker analysis\nHas provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the start of study intervention\nHas adequate organ function as demonstrated by laboratory testing within 10 days prior to the start of study treatment'}

{'Arm - Disease - Indication': 'Adult First-Line HER2 Negative Previously Untreated Locally Advanced Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05001971

{'Official Title': 'Anlotinib Plus Penpulimab for the Treatment of Sensitive Relapsed Small-Cell Lung Cancer: a Multicenter, Single-arm, Explorative Trial', 'Brief Summary': "Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor cell proliferation related kinase -c-Kit kinase. In the phase II ALTER1202 trial, patients who failed at least two kinds of systemic chemotherapy regimens (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 4.1 months and 7.3 months, the placebo group PFS and OS were 0.7 months and 4.9 months. Therefore, the combination of Anlotinib and Penpulimab (a new PD-1 inhibitor) is attempted for the treatment of sensitive relapsed small-cell lung cancer patients who were failure in the first-line treatment of chemotherapy with platinum containing drugs, to further improve the patient's PFS or OS", 'Condition': 'Small Cell Lung Cancer', 'Detailed Description': 'This is a multicenter, single-arm, explorative clinical trial conducted in China to investigate the effectiveness and safety of Anlotinib Plus Penpulimab in patients of sensitive relapsed small-cell lung cancer.\r\n\r\nEligible patients will receive Anlotinib plus Penpulimab:\r\n\r\nAnlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. Penpulimab: 200mg by intravenous drip on day 1 of a 21-day cycle.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nsigned and dated informed consent\r\nSmall cell lung cancer pathologically confirmed, with measurable nidus (RECIST 1.1)\r\nhave failed for first-line chemotherapy\r\nhave a time interval ≥ 3 months between relapse and the end of the last systemic chemotherapy\r\nECOG PS: 0-1, Expected Survival Time: Over 3 months\r\nmain organs function is normal\r\nthe woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 8 weeks after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.'}

{'Arm - Disease - Indication': 'Sensitive Relapsed Small-Cell Lung Cancer'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03064867

{'Official Title': 'Phase I/II Trial of Venetoclax in Combination With R-ICE (V+RICE) Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma', 'Brief Summary': 'The purpose of this study is to determine the correct dose and safety of adding a new cancer drug, venetoclax, to a standard combination of chemotherapy drugs as a second treatment for relapsed/refractory DLBCL. In this study, venetoclax will be added to RICE (rituximab, ifosfamide, carboplatin, etoposide), a common set to cancer drugs used as a second line treatment for relapsed/refractory DLBCL.\r\n\r\nVenetoclax, is a new targeted anti-cancer drug, which works by mimicking a particular protein produced by the tumor and interrupting its normal processes, ultimately causing the tumor cells to die. Adding venetoclax to the standard RICE regimen is believed to increase the chance of getting cancer into remission.\r\n\r\nVenetoclax is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of relapsed/refractory DLBCL. Venetoclax has been FDA approved for use in patients with chronic lymphocytic leukemia (CLL).', 'Condition': 'Diffuse Large B-cell-lymphoma', 'Detailed Description': 'Primary Objective:\r\n\r\nEstablishment of safety of V+RICE in order to identify the recommended Phase II dose (RPD2)\r\n\r\nSecondary Objectives:\r\n\r\nDetermine the overall response rate (ORR) of V+RICE relative to historical controls of RICE alone in r/r DLBCL.\r\nDetermine the proportion of patients who proceed to autologous stem cell transplantation after V+RICE relative to historical controls.\r\nDescribe the progression-free survival (PFS) and overall survival (OS) for patients treated with V + RICE who do and do not proceed to auto-Stem Cell Transplant, relative to historical controls.\r\nMeasure total number of peripheral blood stem cells collected in patients treated with V + RICE who proceed to stem cell mobilization/harvesting, compared to historical controls.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nHistological confirmation of relapsed/refractory diffuse large B-cell lymphoma after prior rituximab and anthracycline-containing systemic treatment regimen such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), R-EPOCH (rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride), R-HyperCVAD (rituximab, cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone) etc. A biopsy immediately before enrollment is not required.\r\nSubjects must have received no more than 2 prior systemic therapies for lymphoma. Prior therapy with systemic rituximab monotherapy or conventional chemotherapy (i.e. bendamustine, CVP (Cyclophosphamide, Vincristine Sulfate, Prednisone) or other) ± rituximab for indolent non-Hodgkin's lymphoma (NHL) ± maintenance/extended-use rituximab will count as 1 line of systemic therapy.\r\nEastern Cooperative Oncology Group (ECOG) Performance status ≤ 2\r\nSubjects must have normal organ and marrow function as defined below:\r\n\r\nHemoglobin ≥ 8.0 g/dl\r\nAbsolute neutrophil count ≥ 1,000/mcL\r\nPlatelet count ≥ 75,000/mcL\r\nTotal bilirubin ≤ 1.5 X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert's, for whom the maximum will be 2.5 ULN.\r\nAspartate transaminase (AST) (SGOT) ≤ 2.5 X institutional ULN\r\nAlanine transaminase (ALT) (SGPT) ≤ 2.5 X institutional ULN\r\nInternational normalized ratio (INR) ≤ 1.5 ×ULN\r\nPatients must have a calculated serum creatinine clearance > 50 mL/min using Cockcroft-Gault calculation or based on 24-hour urine collection performed within 7 days prior to treatment.\r\nSpecific guidelines will be followed regarding inclusion of relapsed/refractory DLBCL based on Hepatitis B serological testing as follow:\r\n\r\nHBsAg negative, HBcAb negative, HBsAb negative patients are eligible.\r\nHBsAg negative, HBcAb negative, HBsAb positive patients are eligible.\r\nPatients who test positive for HBsAg are ineligible\r\nPatients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a HBV DNA testing performed and protocol eligibility determined as follow:\r\n\r\nIf HBV DNA is positive, the subject is ineligible.\r\nIf HBV DNA is negative, the subject may be included but must undergo HBV DNA PCR testing monthly x 3 months beginning from the start of treatment\r\nSubjects must have the ability to understand and the willingness to sign a written informed consent document.\r\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 30 days after the last dose of venetoclax or 18 months after the last dose of rituximab, whichever is longer.\r\nA woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).\r\n\r\nFor men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\r\nWith female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of rituximab. Men must refrain from donating sperm during this same period.\r\n\r\nWith pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of rituximab to avoid exposing the embryo."}

{'Arm - Disease - Indication': 'Relapsed/\u200bRefractory Diffuse Large B-Cell Lymphoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04308785

{'Official Title': 'A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 2 Study to Investigate the Efficacy and Safety of Atezolizumab With or Without Tiragolumab as Consolidation Therapy in Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy\n', 'Brief Summary': 'This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy.\n', 'Condition': 'Carcinoma, Small Cell Lung\n', 'Detailed Description': 'Participants can receive concurrent or sequential chemoradiotherapy (CRT) as per local standard of care, but they must be randomized within 6 weeks from completion of chemoradiotherapy. Participants should receive 4 cycles of chemotherapy and radiotherapy dose of 56-64 Gy (once daily) before randomization, and those participants who have not progressed during/after CRT will be stratified by response to CRT, radiotherapy timing, and be randomized in a 1:1 ratio to Atezolizumab+Tiragolumab arm or Atezolizumab+placebo arm.\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nSigned Informed Consent Form\nECOG performance status of 0 or 1\nHistologically confirmed limited-stage SCLC.\nPatients who have not progressed during/after chemoradiotherapy.\nConcurrent or sequential chemoradiotherapy per local clinical practice must have been completed within 6 weeks prior to the first study treatment. If concurrent CRT is used, at least two cycles of chemotherapy should have been conducted during radiotherapy. If sequential radiotherapy is used, induction chemotherapy should be given 2 cycles of chemotherapy before thoracic radiotherapy.\nAdequate hematologic and end organ function.\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the final dose of atezolizumab or placebo, and 90 days after the final dose of tiragolumab or placebo, and 6 months for chemotherapy after the last dose of chemotherapy treatment, whichever is later.\nFor men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm.\nPatients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior therapy.\nPatients must submit a pre-treatment tumor tissue sample.'}

{'Arm - Disease - Indication': 'Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04308785

{'Official Title': 'A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 2 Study to Investigate the Efficacy and Safety of Atezolizumab With or Without Tiragolumab as Consolidation Therapy in Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy\n', 'Brief Summary': 'This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy.\n', 'Condition': 'Carcinoma, Small Cell Lung\n', 'Detailed Description': 'Participants can receive concurrent or sequential chemoradiotherapy (CRT) as per local standard of care, but they must be randomized within 6 weeks from completion of chemoradiotherapy. Participants should receive 4 cycles of chemotherapy and radiotherapy dose of 56-64 Gy (once daily) before randomization, and those participants who have not progressed during/after CRT will be stratified by response to CRT, radiotherapy timing, and be randomized in a 1:1 ratio to Atezolizumab+Tiragolumab arm or Atezolizumab+placebo arm.\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nSigned Informed Consent Form\nECOG performance status of 0 or 1\nHistologically confirmed limited-stage SCLC.\nPatients who have not progressed during/after chemoradiotherapy.\nConcurrent or sequential chemoradiotherapy per local clinical practice must have been completed within 6 weeks prior to the first study treatment. If concurrent CRT is used, at least two cycles of chemotherapy should have been conducted during radiotherapy. If sequential radiotherapy is used, induction chemotherapy should be given 2 cycles of chemotherapy before thoracic radiotherapy.\nAdequate hematologic and end organ function.\nFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the final dose of atezolizumab or placebo, and 90 days after the final dose of tiragolumab or placebo, and 6 months for chemotherapy after the last dose of chemotherapy treatment, whichever is later.\nFor men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm.\nPatients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior therapy.\nPatients must submit a pre-treatment tumor tissue sample.'}

{'Arm - Disease - Indication': 'Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01843374

{'Official Title': 'A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Brief Summary': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period', 'Condition': 'Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Detailed Description': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo.\r\n\r\nRandomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy (second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the EORTC to stratify subjects into high or low risk groups in order to ensure balanced randomization to the different treatment groups. For subjects in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required. Approximately 564 subjects will be enrolled at study centers in multiple countries.\r\n\r\nThe study consists of a screening period, a treatment period, and a 90-day follow-up period', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma;\r\nDisease not amenable to curative surgery;\r\nAge 18 and over at the time of consent;\r\nECOG Performance status 0-1;\r\nProgressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent.\r\nRecovered from all toxicities associated with prior treatment, to acceptable baseline status, or a NCI CTCAE Grade of 0 or\r\n1, except for toxicities not considered a safety risk, 7. Measurable diseaseby modified RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma; 8. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization defined as: 9. Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C. 10. Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol- related procedures, including screening evaluations; 11. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. 2. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Days 1 through 90 post last dose. In addition, they must refrain from sperm donation for 90 days after the final dose of investigational product.'}

{'Arm - Disease - Indication': 'Second- or Third-line Unresectable Pleural or Peritoneal Malignant Mesothelioma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01843374

{'Official Title': 'A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Brief Summary': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period', 'Condition': 'Unresectable Pleural or Peritoneal Malignant Mesothelioma', 'Detailed Description': 'This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo.\r\n\r\nRandomization will be stratified by EORTC status (low-risk vs high-risk), line of therapy (second vs third), and anatomical site (pleural vs peritoneal). This study plans to use the EORTC to stratify subjects into high or low risk groups in order to ensure balanced randomization to the different treatment groups. For subjects in whom pemetrexed was contraindicated or not tolerated or not an approved therapy (eg, peritoneal mesothelioma), prior therapy with a first-line platinum-based regimen is required. Approximately 564 subjects will be enrolled at study centers in multiple countries.\r\n\r\nThe study consists of a screening period, a treatment period, and a 90-day follow-up period', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nHistologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma;\r\nDisease not amenable to curative surgery;\r\nAge 18 and over at the time of consent;\r\nECOG Performance status 0-1;\r\nProgressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent.\r\nRecovered from all toxicities associated with prior treatment, to acceptable baseline status, or a NCI CTCAE Grade of 0 or\r\n1, except for toxicities not considered a safety risk, 7. Measurable diseaseby modified RECIST for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma; 8. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization defined as: 9. Negative screening test results for human immunodeficiency virus (HIV), hepatitis A, B and C. 10. Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive authorization in the EU) obtained from the subject/legal representative prior to performing any protocol- related procedures, including screening evaluations; 11. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. 2. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Days 1 through 90 post last dose. In addition, they must refrain from sperm donation for 90 days after the final dose of investigational product.'}

{'Arm - Disease - Indication': 'Second- or Third-line Unresectable Pleural or Peritoneal Malignant Mesothelioma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03504397

{'Official Title': 'A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Brief Summary': 'A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.\n\nWhy is this study being done?\n\nSPOTLIGHT is a new clinical study for adult patients who have any of:\n\nadvanced unresectable gastric or GEJ cancer\nmetastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.\nFor patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.\n\nPatients will be assigned to one of two groups by chance and given either:\n\nzolbetuximab with mFOLFOX6; or\na placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.\nThe goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.', 'Condition': 'Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Detailed Description': 'The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.', 'Inclusion Criteria': "Inclusion Criteria:\n\nFemale subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:\n\nNot a woman of child-bearing potential (WOCBP) OR\nWOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs\nFemale subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nFemale subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.\nA sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.\nMale subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nMale subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.\nSubject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.\nSubject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.\nSubject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\nSubject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.\nSubject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.\nSubject has ECOG performance status 0 to 1.\nSubject has predicted life expectancy ≥ 12 weeks.\nSubject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.\n\nHemoglobin (Hgb) ≥ 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.\nAbsolute neutrophil count (ANC) ≥ 1.5 x 10^9/L\nPlatelets ≥ 100 x 10^9/L\nAlbumin ≥ 2.5 g/dL\nTotal bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)\nEstimated creatinine clearance ≥ 30 mL/min\nProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)"}

{'Arm - Disease - Indication': 'Adult Claudin 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03504397

{'Official Title': 'A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Brief Summary': 'A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.\n\nWhy is this study being done?\n\nSPOTLIGHT is a new clinical study for adult patients who have any of:\n\nadvanced unresectable gastric or GEJ cancer\nmetastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.\nFor patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.\n\nPatients will be assigned to one of two groups by chance and given either:\n\nzolbetuximab with mFOLFOX6; or\na placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.\nThe goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.', 'Condition': 'Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Detailed Description': 'The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up.', 'Inclusion Criteria': "Inclusion Criteria:\n\nFemale subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:\n\nNot a woman of child-bearing potential (WOCBP) OR\nWOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs\nFemale subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nFemale subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.\nA sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.\nMale subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.\nMale subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.\nSubject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.\nSubject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.\nSubject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\nSubject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.\nSubject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.\nSubject has ECOG performance status 0 to 1.\nSubject has predicted life expectancy ≥ 12 weeks.\nSubject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.\n\nHemoglobin (Hgb) ≥ 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.\nAbsolute neutrophil count (ANC) ≥ 1.5 x 10^9/L\nPlatelets ≥ 100 x 10^9/L\nAlbumin ≥ 2.5 g/dL\nTotal bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)\nEstimated creatinine clearance ≥ 30 mL/min\nProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)"}

{'Arm - Disease - Indication': 'Adult Claudin 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01004978

{'Official Title': 'A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion', 'Brief Summary': 'This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.', 'Condition': 'Hepatocellular Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\r\n\r\nI. To compare progression-free survival (PFS) of chemoembolization alone to sorafenib (sorafenib tosylate) in combination with chemoembolization.\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To compare overall survival (OS) of chemoembolization alone to sorafenib in combination with chemoembolization.\r\n\r\nII. To evaluate extra-hepatic versus intra-hepatic patterns of failure. III. To determine the rates of toxicity related to sorafenib in combination with chemoembolization.\r\n\r\nTERTIARY OBJECTIVES:\r\n\r\nI. To analyze the pharmacogenetic and pharmacokinetic properties of sorafenib including angiogenesis, monooxygenases, polymorphisms and multidrug resistance (MDR).\r\n\r\nII. Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) secondary imaging objective: site versus (vs.) central evaluation of PFS.\r\n\r\nIII. To determine the inter-reader concordance for response characterization at four and eight months by the European Association for the Study of Liver (EASL) criteria.\r\n\r\nIV. To determine the value of objective tumor response at four and eight months by the EASL criteria to predict PFS (by Response Evaluation Criteria in Solid Tumors [RECIST]) and OS.\r\n\r\nV. To evaluate the effects of intra-hepatic vs. extra-hepatic progression on OS.\r\n\r\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\r\n\r\nARM A: Patients receive sorafenib tosylate at 400 mg orally (PO) twice daily (BID) in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of sorafenib tosylate is reached, patients undergo transarterial chemoembolization (TACE) comprising doxorubicin hydrochloride, mitomycin C, and cisplatin (closed to accrual as of 10/1/2010); conventional chemoembolization comprising doxorubicin hydrochloride only; or chemoembolization comprising doxorubicin-eluting beads. Treatment with TACE repeats approximately every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.\r\n\r\nARM B: Patients receive placebo PO BID in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of placebo is reached, patients undergo TACE as in Arm A.\r\n\r\nMAINTENANCE THERAPY: After completion of chemoembolization, patients receive sorafenib tosylate or placebo as in Arm A and B in the absence of disease progression or unacceptable toxicity.\r\n\r\nAfter completion of study treatment, patients are followed up for 4 years.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:\r\n\r\nHistologically confirmed\r\nMagnetic resonance imaging (MRI) or computerized tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion > 2 cm with early enhancement and delayed enhancement washout regardless of alpha-feto protein levels (AFP)\r\nAFP > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless of specific imaging characteristics on CT or MRI\r\nPatients must have hepatocellular carcinoma (HCC) limited to the liver\r\nPortal lymphadenopathy is permitted for patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) - as lymphadenopathy is commonly associated with hepatitis unrelated to malignancy\r\nStaging CT of the chest and CT or MRI of the abdomen and pelvis must have been completed within 4 weeks of study registration\r\nPatients must have measurable disease constituting < 50% of liver parenchyma within 4 weeks of registration\r\nPatients may have been treated with RFA in the past, but no sooner than 4 weeks before study registration\r\nPatients may have undergone previously attempted curative liver resection\r\nBranch portal vein invasion by tumor is permitted\r\nPatients must have Child-Pugh score of A or B7 within 4 weeks prior to study registration\r\nSerum total bilirubin =< 2.0 mg/dL\r\nAlkaline phosphatase < 5 x upper limit of normal (ULN)\r\nAspartate aminotransferase (AST), alanine aminotransferase (ALT) < 5 x ULN\r\nSerum creatinine =< 1.5 mg/dL\r\nPlatelet count >= 50,000/mm^3\r\nPatients must meet New York Heart Association functional classification I or II defined as:\r\n\r\nClass I - patients with no limitation of activities; they suffer no symptoms from ordinary activities\r\nClass II - patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion\r\nPatients must have an ECOG performance status of 0 or 1\r\nPatients must have a life expectancy of at least 3 months\r\nWomen of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception\r\nPatient must be able to swallow pills, as study medications cannot be crushed'}

{'Arm - Disease - Indication': 'Unresectable Hepatocellular Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT01004978

{'Official Title': 'A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion', 'Brief Summary': 'This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.', 'Condition': 'Hepatocellular Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\r\n\r\nI. To compare progression-free survival (PFS) of chemoembolization alone to sorafenib (sorafenib tosylate) in combination with chemoembolization.\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To compare overall survival (OS) of chemoembolization alone to sorafenib in combination with chemoembolization.\r\n\r\nII. To evaluate extra-hepatic versus intra-hepatic patterns of failure. III. To determine the rates of toxicity related to sorafenib in combination with chemoembolization.\r\n\r\nTERTIARY OBJECTIVES:\r\n\r\nI. To analyze the pharmacogenetic and pharmacokinetic properties of sorafenib including angiogenesis, monooxygenases, polymorphisms and multidrug resistance (MDR).\r\n\r\nII. Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) secondary imaging objective: site versus (vs.) central evaluation of PFS.\r\n\r\nIII. To determine the inter-reader concordance for response characterization at four and eight months by the European Association for the Study of Liver (EASL) criteria.\r\n\r\nIV. To determine the value of objective tumor response at four and eight months by the EASL criteria to predict PFS (by Response Evaluation Criteria in Solid Tumors [RECIST]) and OS.\r\n\r\nV. To evaluate the effects of intra-hepatic vs. extra-hepatic progression on OS.\r\n\r\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\r\n\r\nARM A: Patients receive sorafenib tosylate at 400 mg orally (PO) twice daily (BID) in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of sorafenib tosylate is reached, patients undergo transarterial chemoembolization (TACE) comprising doxorubicin hydrochloride, mitomycin C, and cisplatin (closed to accrual as of 10/1/2010); conventional chemoembolization comprising doxorubicin hydrochloride only; or chemoembolization comprising doxorubicin-eluting beads. Treatment with TACE repeats approximately every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.\r\n\r\nARM B: Patients receive placebo PO BID in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of placebo is reached, patients undergo TACE as in Arm A.\r\n\r\nMAINTENANCE THERAPY: After completion of chemoembolization, patients receive sorafenib tosylate or placebo as in Arm A and B in the absence of disease progression or unacceptable toxicity.\r\n\r\nAfter completion of study treatment, patients are followed up for 4 years.', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nPatients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:\r\n\r\nHistologically confirmed\r\nMagnetic resonance imaging (MRI) or computerized tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion > 2 cm with early enhancement and delayed enhancement washout regardless of alpha-feto protein levels (AFP)\r\nAFP > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless of specific imaging characteristics on CT or MRI\r\nPatients must have hepatocellular carcinoma (HCC) limited to the liver\r\nPortal lymphadenopathy is permitted for patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) - as lymphadenopathy is commonly associated with hepatitis unrelated to malignancy\r\nStaging CT of the chest and CT or MRI of the abdomen and pelvis must have been completed within 4 weeks of study registration\r\nPatients must have measurable disease constituting < 50% of liver parenchyma within 4 weeks of registration\r\nPatients may have been treated with RFA in the past, but no sooner than 4 weeks before study registration\r\nPatients may have undergone previously attempted curative liver resection\r\nBranch portal vein invasion by tumor is permitted\r\nPatients must have Child-Pugh score of A or B7 within 4 weeks prior to study registration\r\nSerum total bilirubin =< 2.0 mg/dL\r\nAlkaline phosphatase < 5 x upper limit of normal (ULN)\r\nAspartate aminotransferase (AST), alanine aminotransferase (ALT) < 5 x ULN\r\nSerum creatinine =< 1.5 mg/dL\r\nPlatelet count >= 50,000/mm^3\r\nPatients must meet New York Heart Association functional classification I or II defined as:\r\n\r\nClass I - patients with no limitation of activities; they suffer no symptoms from ordinary activities\r\nClass II - patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion\r\nPatients must have an ECOG performance status of 0 or 1\r\nPatients must have a life expectancy of at least 3 months\r\nWomen of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception\r\nPatient must be able to swallow pills, as study medications cannot be crushed'}

{'Arm - Disease - Indication': 'Unresectable Hepatocellular Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04543617

{'Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy\n', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).\n', 'Condition': 'Esophageal Squamous Cell Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\nHistologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus\nUnresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study\ndCRT treatment according to regional oncology guidelines for esophageal cancer\nRepresentative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT\nAdequate hematologic and end-organ function prior to randomization\nWomen of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later\nMen must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.'}

{'Arm - Disease - Indication': 'Unresectable Esophageal Squamous Cell Carcinoma Non-Progressive Following Definitive Concurrent Chemoradiotherapy '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04543617

{'Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy\n', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).\n', 'Condition': 'Esophageal Squamous Cell Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\nHistologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus\nUnresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study\ndCRT treatment according to regional oncology guidelines for esophageal cancer\nRepresentative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT\nAdequate hematologic and end-organ function prior to randomization\nWomen of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later\nMen must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.'}

{'Arm - Disease - Indication': 'Unresectable Esophageal Squamous Cell Carcinoma Non-Progressive Following Definitive Concurrent Chemoradiotherapy '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT04543617

{'Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy\n', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).\n', 'Condition': 'Esophageal Squamous Cell Carcinoma\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\nHistologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus\nUnresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study\ndCRT treatment according to regional oncology guidelines for esophageal cancer\nRepresentative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT\nAdequate hematologic and end-organ function prior to randomization\nWomen of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later\nMen must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.'}

{'Arm - Disease - Indication': 'Unresectable Esophageal Squamous Cell Carcinoma Non-Progressive Following Definitive Concurrent Chemoradiotherapy '}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05904886

{'Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma\n', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).\n', 'Condition': 'Carcinoma, Hepatocellular\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nLocally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants\nDisease that is not amenable to curative surgical and/or locoregional therapies\nNo prior systemic treatment for locally advanced or metastatic and/or unresectable HCC\nMeasurable disease according to RECIST v1.1\nECOG Performance Status of 0 or 1 within 7 days prior to randomization\nChild-Pugh Class A within 7 days prior to randomization\nAdequate hematologic and end-organ function\nFemale participants of childbearing potential must be willing to avoid pregnancy\nMale participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab to avoid exposing the embryo.'}

{'Arm - Disease - Indication': 'First-Line Untreated Locally Advanced or Metastatic and/or Unresectable Hepatocellular Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT05904886

{'Official Title': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma\n', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).\n', 'Condition': 'Carcinoma, Hepatocellular\n', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\n\nLocally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants\nDisease that is not amenable to curative surgical and/or locoregional therapies\nNo prior systemic treatment for locally advanced or metastatic and/or unresectable HCC\nMeasurable disease according to RECIST v1.1\nECOG Performance Status of 0 or 1 within 7 days prior to randomization\nChild-Pugh Class A within 7 days prior to randomization\nAdequate hematologic and end-organ function\nFemale participants of childbearing potential must be willing to avoid pregnancy\nMale participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab to avoid exposing the embryo.'}

{'Arm - Disease - Indication': 'First-Line Untreated Locally Advanced or Metastatic and/or Unresectable Hepatocellular Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03592472

{'Official Title': 'A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV)\n', 'Brief Summary': 'This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).\n', 'Condition': 'Renal Cell Carcinoma\n', 'Detailed Description': 'In this randomized, Phase 3, double-blind, placebo-controlled study, patients will be randomized 2:1 to receive either a combination of pazopanib plus abexinostat or pazopanib plus placebo. At the time of disease progression, patient treatment assignment will be unblinded, and those patients randomized to the pazopanib plus placebo treatment arm will have the option of crossing over to receive treatment with a combination of pazopanib plus abexinostat. After providing written informed consent, patients will be screened for study eligibility within 28 days before their first dose of study drug. After screening assessments, patients who are eligible for inclusion in the study will be randomized and receive their first dose of study drug on Cycle 1 Day 1 (C1D1), within 7 days of randomization. A treatment cycle is 28 days in length. Patients may continue to receive study drug until any of the following events: the development of IRC-verified radiographic progression as assessed by RECIST version 1.1, clinical disease progression, unacceptable toxicity, another discontinuation criterion is met, withdrawal of consent, or closure of the study by the sponsor. No maximum duration of therapy has been set.\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nTo be enrolled in the study, patients will be required to meet all of the following criteria:\n\nPatients aged ≥ 18 years at time of study entry.\nPatients have histologically confirmed RCC with clear cell component.\nPatients have locally advanced and unresectable or metastatic disease.\nMeasurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.\nPatients must not have had any prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced/metastatic setting. Up to 1 line of prior cytokine or immune checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment.\nPatients have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\nPatients have adequate baseline organ function.\nPatients have adequate baseline hematologic function\nPatient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.'}

{'Arm - Disease - Indication': 'Unresectable Locally Advanced or Metastatic Renal Cell Carcinoma'}

Indication Extraction Guideline 1. Review the “arms data” and identify the indication From the clinical trial arm. 2. Rely only on "arms data" to identify the indication. The "arms data" may be incomplete or irrelevant. You should not make assumptions about the "arms data" beyond what is mentioned. 3. Ensure to identify only the indication. 4. Avoid any unrelated conditions or symptoms, and any other additional context. 5. Return just the indication. Do not write a para. 6. Refer to these examples for formatting: Return Indication - Previously Treated Metastatic Castration-Resistant Prostate Cancer

NCT03592472

{'Official Title': 'A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV)\n', 'Brief Summary': 'This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).\n', 'Condition': 'Renal Cell Carcinoma\n', 'Detailed Description': 'In this randomized, Phase 3, double-blind, placebo-controlled study, patients will be randomized 2:1 to receive either a combination of pazopanib plus abexinostat or pazopanib plus placebo. At the time of disease progression, patient treatment assignment will be unblinded, and those patients randomized to the pazopanib plus placebo treatment arm will have the option of crossing over to receive treatment with a combination of pazopanib plus abexinostat. After providing written informed consent, patients will be screened for study eligibility within 28 days before their first dose of study drug. After screening assessments, patients who are eligible for inclusion in the study will be randomized and receive their first dose of study drug on Cycle 1 Day 1 (C1D1), within 7 days of randomization. A treatment cycle is 28 days in length. Patients may continue to receive study drug until any of the following events: the development of IRC-verified radiographic progression as assessed by RECIST version 1.1, clinical disease progression, unacceptable toxicity, another discontinuation criterion is met, withdrawal of consent, or closure of the study by the sponsor. No maximum duration of therapy has been set.\n', 'Inclusion Criteria': 'Inclusion Criteria:\n\nTo be enrolled in the study, patients will be required to meet all of the following criteria:\n\nPatients aged ≥ 18 years at time of study entry.\nPatients have histologically confirmed RCC with clear cell component.\nPatients have locally advanced and unresectable or metastatic disease.\nMeasurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.\nPatients must not have had any prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced/metastatic setting. Up to 1 line of prior cytokine or immune checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment.\nPatients have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\nPatients have adequate baseline organ function.\nPatients have adequate baseline hematologic function\nPatient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.'}

{'Arm - Disease - Indication': 'Unresectable Locally Advanced or Metastatic Renal Cell Carcinoma'}

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'}