Datasets:

Ketak-ZoomRx

/

M6_2109

like 0

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

NCT03809988

{'Official Title': 'International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.', 'Brief Summary': 'Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)', 'Condition': 'Breast Cancer\nAdvanced Breast Cancer\nHormone Receptor Positive Tumor\nHuman Epidermal Growth Factor 2 Negative Carcinoma of Breast', 'Detailed Description': 'Pre- and post-menopausal women age ≥ 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH)', 'Inclusion Criteria': "Inclusion Criteria:\n\nFemale patients over 18 years of age.\nPre-menopausal women provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/Follicle-stimulating hormone (FSH) must be confirmed analytically) prior to study entry or post- menopausal women as defined by any of the following criteria:\n\nAge ≥60 years;\nAge <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory's reference range for postmenopausal females;\nDocumented bilateral oophorectomy.\nEastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1.\nLife expectancy greater or equal to 12 weeks.\nHistologically proven diagnosed of ABC not amenable to curative treatment.\nDocumented recurrent ER-positive and/or progesterone receptor (PgR)-positive (with ≥1% positive stained cells (according to NCCN National Comprehensive Cancer Network and ASCO American Society of Clinical Oncology guidelines) and HER2-negative (0-1+ by immunohistochemistry (IHC) or 2+ and negative by in situ hybridization (ISH) test) breast cancer in the advanced setting.\nRadiological or clinical evidence of disease progression on first- line combination of palbociclib plus endocrine therapy (aromatase inhibitor (AI) or fulvestrant). Patients previously treated with the combination of palbociclib and tamoxifen will be excluded.\nPatients have achieved clinical benefit criteria to a first-line palbociclib-based endocrine regimen (defined as at least stable disease ≥ 24 weeks or partial or complete response confirmed or unconfirmed).\nPatients must have been treated with a stable minimum dose of 75 mg palbociclib during the last 2 cycles of the prior palbociclib-based regimen.\nLast dose of palbociclib administered not later than 8 weeks and not earlier than 7 days from study entry, with the exception of patients relapsing on a palbociclib-based regimen in the adjuvant setting.\nPatients should not have been treated in the advanced setting with at least one of these endocrine therapy options: either fulvestrant or AI.\nPatients must have measurable disease or evaluable disease according to RECIST criteria v.1.1. Patients with only bone lesions are eligible.\nWillingness and ability to provide tumor biopsy (if feasible) both at the time of the inclusion and after disease progression in order to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee.\nPatients agree to collection of blood samples (liquid biopsy) at the time of inclusion, after 2 weeks of treatment, and upon progression or study termination.\nAdequate organ function: (Hematological, hepatic and renal)\nPatients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\nPatients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.\nResolution of all acute toxic effects of prior anti-cancer therapy to grade 1"}

{'Arm - Disease - Indication': 'HR-Positive HER2-Negative Advanced Breast Cancer'}

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

NCT03809988

{'Official Title': 'International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.', 'Brief Summary': 'Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)', 'Condition': 'Breast Cancer\r\nAdvanced Breast Cancer\r\nHormone Receptor Positive Tumor\r\nHuman Epidermal Growth Factor 2 Negative Carcinoma of Breast', 'Detailed Description': 'Pre- and post-menopausal women age ≥ 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH)', 'Inclusion Criteria': "Inclusion Criteria:\n\nFemale patients over 18 years of age.\nPre-menopausal women provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/Follicle-stimulating hormone (FSH) must be confirmed analytically) prior to study entry or post- menopausal women as defined by any of the following criteria:\n\nAge ≥60 years;\nAge <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory's reference range for postmenopausal females;\nDocumented bilateral oophorectomy.\nEastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1.\nLife expectancy greater or equal to 12 weeks.\nHistologically proven diagnosed of ABC not amenable to curative treatment.\nDocumented recurrent ER-positive and/or progesterone receptor (PgR)-positive (with ≥1% positive stained cells (according to NCCN National Comprehensive Cancer Network and ASCO American Society of Clinical Oncology guidelines) and HER2-negative (0-1+ by immunohistochemistry (IHC) or 2+ and negative by in situ hybridization (ISH) test) breast cancer in the advanced setting.\nRadiological or clinical evidence of disease progression on first- line combination of palbociclib plus endocrine therapy (aromatase inhibitor (AI) or fulvestrant). Patients previously treated with the combination of palbociclib and tamoxifen will be excluded.\nPatients have achieved clinical benefit criteria to a first-line palbociclib-based endocrine regimen (defined as at least stable disease ≥ 24 weeks or partial or complete response confirmed or unconfirmed).\nPatients must have been treated with a stable minimum dose of 75 mg palbociclib during the last 2 cycles of the prior palbociclib-based regimen.\nLast dose of palbociclib administered not later than 8 weeks and not earlier than 7 days from study entry, with the exception of patients relapsing on a palbociclib-based regimen in the adjuvant setting.\nPatients should not have been treated in the advanced setting with at least one of these endocrine therapy options: either fulvestrant or AI.\nPatients must have measurable disease or evaluable disease according to RECIST criteria v.1.1. Patients with only bone lesions are eligible.\nWillingness and ability to provide tumor biopsy (if feasible) both at the time of the inclusion and after disease progression in order to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee.\nPatients agree to collection of blood samples (liquid biopsy) at the time of inclusion, after 2 weeks of treatment, and upon progression or study termination.\nAdequate organ function: (Hematological, hepatic and renal)\nPatients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\nPatients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.\nResolution of all acute toxic effects of prior anti-cancer therapy to grade 1"}

{'Arm - Disease - Indication': 'HR-Positive HER2-Negative Advanced Breast Cancer'}

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

NCT04158440

{'Official Title': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.', 'Condition': 'Stage II-III Non-small Cell Lung Cancer', 'Detailed Description': 'Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below:\nDisease stage: II vs IIIA vs IIIB\nPD-L1 status: PD-L1 expression ≥1% vs. PD-L1 <1% or not evaluable\nPlanned surgical operation: pneumonectomy vs. lobectomy\nPathological type: non-squamous cell carcinoma vs. squamous cell carcinoma Neoadjuvant therapy should be started within 3 days after randomization. Toripalimab IV 240 mg Q3W /plaecbo will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group; Every 3 weeks of treatment is regarded as one cycle, in which combined therapy is given in the first day of every cycle.\nAll the subjects will receive preoperative radiological and surgical evaluation 3-5 weeks after neoadjuvant therapy.\nAfter 3 cycles of preoperative neoadjuvant therapy, all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy. The pTNM will be staged in accordance with AJCC Cancer Staging Manual (version 8). All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research.\nAll the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy, i.e., Toripalimab IV 240 mg/placebo + platinum-based doublet drug chemotherapy in 30 days after the operation. If there is no adjuvant radiotherapy plan, it will proceed to consolidation treatment period three weeks after adjuvant therapy; if adjuvant radiotherapy is planned then the consolidation treatment period will start 30 days after adjuvant radiotherapy. In the consolidation treatment period, Toripalimab IV 240 mg/placebo is given in each cycle of every 3 weeks for a total of 13 cycles . Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study.', 'Inclusion Criteria': 'Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);\nAged 18-70 years, male or female;\nTreatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as eligible for radical resection evaluated by a qualified thoracic surgeon; resectable stage III is defined as the resectable and potential resectable according to the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019)in which resectable includes IIIA(N0-1), partial N2 with single-station mediastinal lymph node metastasis and the short diameter of lymph node<2 cm， partial T4 (satellite nodules in the adjacent lobe) N1 and potential resectable includes partial stage IIIA and IIIB with the short diameter of single-station N2 mediastinal lymph node<3 cm, other potentially resectable T3 or T4 central tumor ; Any suspected lesions which could change the TNM stage, such as contralateral mediastinal lymph node, supraclavicular lymph mode, solid/sub-solid pulmonary node and non-isolated ground glass opacity (GGO), pathological confirmation is strongly recommended.\nMeasurable lesions based on the response evaluation criteria in solid tumors version 1.1;\nTumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment; tumor tissue specimens must be the samples of histological category, including but not limited to the tissue punctured by core needle and hollow needle, tissue acquired by bronchoscopic clamp, surgically resected samples; the samples acquired by fine needle puncture and bronchial brushing are not acceptable);\nECOG score 0-1;\nGood organ function:\nBeing willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;\npulmonary function test being able to withstand the planned pneumonectomy evaluated by surgeons; Women of childbearing potential must undergo serum pregnancy test within 3 hours prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug.\nWomen of childbearing potential must undergo serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug'}

{'Arm - Disease - Indication': 'Treatment-naive Resectable Stage II-III Non Small Cell Lung Cancer'}

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

NCT04158440

{'Official Title': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study on Toripalimab Combined With Platinum-Based Doublet Drug Chemotherapy for Resectable, Stage II-III, Non-Small Cell Lung Cancer', 'Brief Summary': 'This is a randomized, double-blind, placebo-controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab injection (JS001) combined with platinum-based doublet drug chemotherapy versus placebo combined with platinum-based doublet drug chemotherapy for subjects with resectable, stage II-III NSCLC.', 'Condition': 'Stage II-III Non-small Cell Lung Cancer', 'Detailed Description': 'Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below:\nDisease stage: II vs IIIA vs IIIB\nPD-L1 status: PD-L1 expression ≥1% vs. PD-L1 <1% or not evaluable\nPlanned surgical operation: pneumonectomy vs. lobectomy\nPathological type: non-squamous cell carcinoma vs. squamous cell carcinoma Neoadjuvant therapy should be started within 3 days after randomization. Toripalimab IV 240 mg Q3W /plaecbo will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group; Every 3 weeks of treatment is regarded as one cycle, in which combined therapy is given in the first day of every cycle.\nAll the subjects will receive preoperative radiological and surgical evaluation 3-5 weeks after neoadjuvant therapy.\nAfter 3 cycles of preoperative neoadjuvant therapy, all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy. The pTNM will be staged in accordance with AJCC Cancer Staging Manual (version 8). All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research.\nAll the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy, i.e., Toripalimab IV 240 mg/placebo + platinum-based doublet drug chemotherapy in 30 days after the operation. If there is no adjuvant radiotherapy plan, it will proceed to consolidation treatment period three weeks after adjuvant therapy; if adjuvant radiotherapy is planned then the consolidation treatment period will start 30 days after adjuvant radiotherapy. In the consolidation treatment period, Toripalimab IV 240 mg/placebo is given in each cycle of every 3 weeks for a total of 13 cycles . Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study.', 'Inclusion Criteria': 'Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);\nAged 18-70 years, male or female;\nTreatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC; cTNM stage can be confirmed through PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as eligible for radical resection evaluated by a qualified thoracic surgeon; resectable stage III is defined as the resectable and potential resectable according to the Chinese expert consensus on the multidisciplinary diagnosis and treatment for stage III non-small cell lung cancer (2019)in which resectable includes IIIA(N0-1), partial N2 with single-station mediastinal lymph node metastasis and the short diameter of lymph node<2 cm， partial T4 (satellite nodules in the adjacent lobe) N1 and potential resectable includes partial stage IIIA and IIIB with the short diameter of single-station N2 mediastinal lymph node<3 cm, other potentially resectable T3 or T4 central tumor ; Any suspected lesions which could change the TNM stage, such as contralateral mediastinal lymph node, supraclavicular lymph mode, solid/sub-solid pulmonary node and non-isolated ground glass opacity (GGO), pathological confirmation is strongly recommended.\nMeasurable lesions based on the response evaluation criteria in solid tumors version 1.1;\nTumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization (the tumor tissue specimens must be freshly obtained or archived samples within 3 months prior to enrollment; tumor tissue specimens must be the samples of histological category, including but not limited to the tissue punctured by core needle and hollow needle, tissue acquired by bronchoscopic clamp, surgically resected samples; the samples acquired by fine needle puncture and bronchial brushing are not acceptable);\nECOG score 0-1;\nGood organ function:\nBeing willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;\npulmonary function test being able to withstand the planned pneumonectomy evaluated by surgeons; Women of childbearing potential must undergo serum pregnancy test within 3 hours prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug.\nWomen of childbearing potential must undergo serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug'}

{'Arm - Disease - Indication': 'Treatment-naive Resectable Stage II-III Non Small Cell Lung Cancer'}

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

NCT02853331

{'Official Title': 'A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC).\nThe primary hypotheses of this study are:\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features\nHas locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease\nHas measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist\nHas received no prior systemic therapy for advanced RCC.\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.\nHas Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to randomization.\nIf receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.\nDemonstrates adequate organ function.\nFemale participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.\nMale participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.'}

{'Arm - Disease - Indication': 'First-line Locally Advanced or Advanced or Metastatic Clear Cell Renal Cell Carcinoma'}

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

NCT02853331

{'Official Title': 'A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)', 'Brief Summary': 'The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC).\nThe primary hypotheses of this study are:\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)\nThe combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).', 'Condition': 'Renal Cell Carcinoma', 'Detailed Description': '-', 'Inclusion Criteria': 'Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features\nHas locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease\nHas measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist\nHas received no prior systemic therapy for advanced RCC.\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.\nHas Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to randomization.\nIf receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.\nDemonstrates adequate organ function.\nFemale participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.\nMale participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.'}

{'Arm - Disease - Indication': 'First-line Locally Advanced or Advanced or Metastatic Clear Cell Renal Cell Carcinoma'}

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

NCT04744831

{'Official Title': 'A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)', 'Brief Summary': 'This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).', 'Condition': 'Advanced Colorectal Cancer', 'Detailed Description': 'This 2-stage study will evaluate participants with locally advanced, unresectable, or metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC 2+/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor type, previously treated with standard therapy. In the first stage, participants will be randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further eligible participants will be registered to T-DXd administered IV in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.', 'Inclusion Criteria': 'KEY Inclusion Criteria:\nParticipants must meet all of the following criteria to be eligible for randomization/registration into the study:\nAdults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥18 years in other countries, at the time the Informed Consent Forms (ICFs) are signed.\nPathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status identified in primary or metastatic site.\nThe following therapies should be included in prior lines of therapy:\nFluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated\nAnti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type and if clinically indicated\nAnti-vascular endothelial growth factor (VEGF) treatment, if clinically indicated\nAnti-programmed death ligand 1 (PD-(L)-1) therapy, if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high, if clinically indicated\nConfirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ hybridization (ISH) +.\nPresence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.\nEastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\nHas left ventricular ejection fraction (LVEF) ≥50% within 28 days before randomization/registration.'}

{'Arm - Disease - Indication': 'HER2-Overexpressing BRAF Wild-type Locally Advanced or Advanced Recurrent Unresectable or Metastatic Colorectal Adenocarcinoma'}

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

NCT04744831

{'Official Title': 'A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)', 'Brief Summary': 'This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).', 'Condition': 'Advanced Colorectal Cancer', 'Detailed Description': 'This 2-stage study will evaluate participants with locally advanced, unresectable, or metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC 2+/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor type, previously treated with standard therapy. In the first stage, participants will be randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further eligible participants will be registered to T-DXd administered IV in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.', 'Inclusion Criteria': 'KEY Inclusion Criteria:\nParticipants must meet all of the following criteria to be eligible for randomization/registration into the study:\nAdults aged ≥20 years in Japan, Taiwan, and Korea, or those aged ≥18 years in other countries, at the time the Informed Consent Forms (ICFs) are signed.\nPathologically-documented, unresectable, recurrent, or metastatic colorectal adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status identified in primary or metastatic site.\nThe following therapies should be included in prior lines of therapy:\nFluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated\nAnti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type and if clinically indicated\nAnti-vascular endothelial growth factor (VEGF) treatment, if clinically indicated\nAnti-programmed death ligand 1 (PD-(L)-1) therapy, if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR), or tumor mutational burden (TMB)-high, if clinically indicated\nConfirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ hybridization (ISH) +.\nPresence of at least one measurable lesion assessed by the Investigator per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.\nEastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\nHas left ventricular ejection fraction (LVEF) ≥50% within 28 days before randomization/registration.'}

{'Arm - Disease - Indication': 'HER2-Overexpressing BRAF Wild-type Locally Advanced or Advanced Recurrent Unresectable or Metastatic Colorectal Adenocarcinoma'}

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

NCT02998528

{'Official Title': 'Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC', 'Brief Summary': "The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.\nThis study has multiple primary endpoints.", 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nEarly stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\nLung function capacity capable of tolerating the proposed lung surgery\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\nAvailable tissue of primary lung tumor'}

{'Arm - Disease - Indication': 'Early Stage IB-IIIA Resectable Non Small Cell Lung Cancer'}

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

NCT02998528

{'Official Title': 'Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC', 'Brief Summary': "The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.\nThis study has multiple primary endpoints.", 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nEarly stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\nLung function capacity capable of tolerating the proposed lung surgery\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\nAvailable tissue of primary lung tumor'}

{'Arm - Disease - Indication': 'Early Stage IB-IIIA Resectable Non Small Cell Lung Cancer'}

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

NCT02998528

{'Official Title': 'Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC', 'Brief Summary': "The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.\nThis study has multiple primary endpoints.", 'Condition': 'Non Small Cell Lung Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nEarly stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\nLung function capacity capable of tolerating the proposed lung surgery\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\nAvailable tissue of primary lung tumor'}

{'Arm - Disease - Indication': 'Early Stage IB-IIIA Resectable Non Small Cell Lung Cancer'}

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

NCT04334941

{'Official Title': 'Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination With Talazoparib in Patients With SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'Brief Summary': "This phase II trial studies whether atezolizumab in combination with talazoparib works better than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body's instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control, but PARP inhibitors like talazoparib may keep PARP from working, so tumor cells can't repair themselves, and they stop growing. Giving atezolizumab in combination with talazoparib may help lower the chance of extensive-stage small cell lung cancer growing and spreading compared to atezolizumab alone.", 'Condition': 'Extensive Stage Lung Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare progression free survival (PFS) among participants with Schlafen family member 11 (SLFN11) positive extensive stage small cell lung cancer (ES-SCLC) randomized to atezolizumab or atezolizumab plus talazoparib as maintenance therapy.\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) between the arms. II. To compare objective response rate (ORR) among participants with measurable disease between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\nIII. To evaluate the frequency and severity of adverse events within each treatment arm.\nTRANSLATIONAL MEDICINE OBJECTIVE:\nI. To bank specimens for future correlative studies.\nOUTLINE: Patients are screened for SLFN11 biomarker during Step 1: Screening Registration by submitting tumor tissue to MDACC. Patients with SLFN11 biomarker are registered to Step 2: Randomization and are randomized to 1 or 2 arms.\nARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1 and talazoparib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nPatients may undergo magnetic resonance imaging (MRI) during screening. Patients undergo tumor biopsy while on study. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.', 'Inclusion Criteria': 'STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible\nSTEP 1: SCREENING REGISTRATION: Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab\nNOTE: Participants may be screened while receiving consolidation thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and/or PCI per the discretion of their treating investigator\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must be >= 18 years of age at the time of Step 1 Screening Registration\nSTEP 1: SCREENING REGISTRATION: Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as:\nAt least two (3-5 microns) (three slides preferred) unstained slides, or;\nOne (3-5 microns) (two slides preferred) unstained slide plus one H&E stained slide\nParticipants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing. Note: A histologic review will be performed at MDACC to confirm adequate cellularity for the testing. If inadequate cellularity, additional unstained slides from the same participant may be submitted if it doesn\'t exceed the window of starting maintenance therapy\nSTEP 1: SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 1: SCREENING REGISTRATION: As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 1: SCREENING REGISTRATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\nSTEP 2: RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) that the participant\'s tumor sample is SLFN11 positive\nSTEP 2: RANDOMIZATION: Participants must have their disease assessed either by computed tomography (CT) of chest/abdomen/pelvis (with contrast, unless contraindicated) within 28 days prior to Step 2 Registration for measurable disease or by positron emission tomography (PET)PET/CT of chest/abdomen/pelvis (with contrast, unless contraindicated) within 42 days prior to Step 2 Registration for non-measurable disease. Participants may have a complete response to induction therapy. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Study participants will not be considered eligible if a non-diagnostic PET/CT of chest/abdomen/pelvis is used to assess measurable disease prior to Step 2 Registration\nSTEP 2: RANDOMIZATION: Patients must have a CT or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 randomization. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to Step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must not have had disease progression based on post induction imaging in the opinion of treating investigator\nSTEP 2: RANDOMIZATION: Participants must be registered to Step 2 Randomization prior to the start of maintenance atezolizumab\nSTEP 2: RANDOMIZATION: Participants must have received no fewer than 2 cycles and no more than 4 cycles of induction treatment with platinum/etoposide/atezolizumab\nSTEP 2: RANDOMIZATION: Participant must not have received radiation treatment (RT) or prophylactic cranial irradiation (PCI) within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be taking strong P-glycoprotein (P-gp) inhibitors (e.g., dronedarone, quinidine, ranolazine), P-gp inducers (e.g., rifampin), or breast cancer resistance protein (BCRP) inhibitors (e.g., elacridar) within 7 days prior to randomization. Participants must not plan to receive the therapies listed above while on protocol treatment)\nSTEP 2: RANDOMIZATION: Participants must not have experienced the following during induction treatment:\nAny grade 3 or worse immune-related adverse event (irAE) in the opinion of the treating investigator. Exception: asymptomatic nonbullous/nonexfoliative rash\nAny unresolved grade 2 irAE\nAny toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy. Exception to the above: Toxicities of any grade that require replacement therapy and have stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed\nSTEP 2: RANDOMIZATION: History and physical exam must be obtained within 28 days prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function and be considered class 2B or better on the New York Heart Association Functional Classification\nSTEP 2: RANDOMIZATION: Participants must have Zubrod performance status 0-2 documented within 28 days prior to Step 2 Randomization.\nSTEP 2: RANDOMIZATION: Leukocytes >= 3 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Absolute neutrophil count >= 1.5 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Platelets >= 100 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Creatinine =< institutional ULN OR estimated creatinine clearance > 30 mL/min (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be able to swallow capsule whole\nSTEP 2: RANDOMIZATION: Participants with known diabetes must not have uncontrolled diabetes. (Uncontrolled diabetes is defined as glycosylated hemoglobin [HgA1C] > 7%)\nSTEP 2: RANDOMIZATION: Participants must not have any known clinically significant liver disease, including cirrhosis, fatty liver, or inherited liver disease\nSTEP 2: RANDOMIZATION: Participants must not have end stage renal or other serious medical illness that may limit survival or the ability to participate in this study\nSTEP 2: RANDOMIZATION: Participants must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\nSTEP 2: RANDOMIZATION: Participants must not have known active tuberculosis (TB)\nSTEP 2: RANDOMIZATION: Participants must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation\nSTEP 2: RANDOMIZATION: Participants must not have history of allergic reaction attributed to compounds of similar chemical or biological composition to atezolizumab and/or talazoparib\nSTEP 2: RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\nSTEP 2: RANDOMIZATION: Participants must not be on corticosteroids at doses greater than prednisone 10 mg daily or equivalent within 7 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not receive any live attenuated vaccines within 28 days prior to Step 2 Randomization or at any time during the study and until 5 months after the last dose of protocol treatment\nSTEP 2: RANDOMIZATION: Participants must not have severe infections in the form of severe sepsis or septic shock including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 7 months after the last dose of protocol treatment. A woman is considered to be of "reproductive potential" if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\nSTEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 2: RANDOMIZATION: As a part of the OPEN registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 2: RANDOMIZATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)'}

{'Arm - Disease - Indication': 'SLFN11-Positive Extensive-Stage Small Cell Lung Carcinoma'}

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

NCT04334941

{'Official Title': 'Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination With Talazoparib in Patients With SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'Brief Summary': "This phase II trial studies whether atezolizumab in combination with talazoparib works better than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body's instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control, but PARP inhibitors like talazoparib may keep PARP from working, so tumor cells can't repair themselves, and they stop growing. Giving atezolizumab in combination with talazoparib may help lower the chance of extensive-stage small cell lung cancer growing and spreading compared to atezolizumab alone.", 'Condition': 'Extensive Stage Lung Small Cell Carcinoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare progression free survival (PFS) among participants with Schlafen family member 11 (SLFN11) positive extensive stage small cell lung cancer (ES-SCLC) randomized to atezolizumab or atezolizumab plus talazoparib as maintenance therapy.\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) between the arms. II. To compare objective response rate (ORR) among participants with measurable disease between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\nIII. To evaluate the frequency and severity of adverse events within each treatment arm.\nTRANSLATIONAL MEDICINE OBJECTIVE:\nI. To bank specimens for future correlative studies.\nOUTLINE: Patients are screened for SLFN11 biomarker during Step 1: Screening Registration by submitting tumor tissue to MDACC. Patients with SLFN11 biomarker are registered to Step 2: Randomization and are randomized to 1 or 2 arms.\nARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nARM II: Patients receive atezolizumab IV over 30-60 minutes on day 1 and talazoparib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\nPatients may undergo magnetic resonance imaging (MRI) during screening. Patients undergo tumor biopsy while on study. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.', 'Inclusion Criteria': 'STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible\nSTEP 1: SCREENING REGISTRATION: Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab\nNOTE: Participants may be screened while receiving consolidation thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and/or PCI per the discretion of their treating investigator\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC\nSTEP 1: SCREENING REGISTRATION: Participants must be >= 18 years of age at the time of Step 1 Screening Registration\nSTEP 1: SCREENING REGISTRATION: Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as:\nAt least two (3-5 microns) (three slides preferred) unstained slides, or;\nOne (3-5 microns) (two slides preferred) unstained slide plus one H&E stained slide\nParticipants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing. Note: A histologic review will be performed at MDACC to confirm adequate cellularity for the testing. If inadequate cellularity, additional unstained slides from the same participant may be submitted if it doesn\'t exceed the window of starting maintenance therapy\nSTEP 1: SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 1: SCREENING REGISTRATION: As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 1: SCREENING REGISTRATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\nSTEP 2: RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) that the participant\'s tumor sample is SLFN11 positive\nSTEP 2: RANDOMIZATION: Participants must have their disease assessed either by computed tomography (CT) of chest/abdomen/pelvis (with contrast, unless contraindicated) within 28 days prior to Step 2 Registration for measurable disease or by positron emission tomography (PET)PET/CT of chest/abdomen/pelvis (with contrast, unless contraindicated) within 42 days prior to Step 2 Registration for non-measurable disease. Participants may have a complete response to induction therapy. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Study participants will not be considered eligible if a non-diagnostic PET/CT of chest/abdomen/pelvis is used to assess measurable disease prior to Step 2 Registration\nSTEP 2: RANDOMIZATION: Patients must have a CT or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 randomization. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to Step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must not have had disease progression based on post induction imaging in the opinion of treating investigator\nSTEP 2: RANDOMIZATION: Participants must be registered to Step 2 Randomization prior to the start of maintenance atezolizumab\nSTEP 2: RANDOMIZATION: Participants must have received no fewer than 2 cycles and no more than 4 cycles of induction treatment with platinum/etoposide/atezolizumab\nSTEP 2: RANDOMIZATION: Participant must not have received radiation treatment (RT) or prophylactic cranial irradiation (PCI) within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be taking strong P-glycoprotein (P-gp) inhibitors (e.g., dronedarone, quinidine, ranolazine), P-gp inducers (e.g., rifampin), or breast cancer resistance protein (BCRP) inhibitors (e.g., elacridar) within 7 days prior to randomization. Participants must not plan to receive the therapies listed above while on protocol treatment)\nSTEP 2: RANDOMIZATION: Participants must not have experienced the following during induction treatment:\nAny grade 3 or worse immune-related adverse event (irAE) in the opinion of the treating investigator. Exception: asymptomatic nonbullous/nonexfoliative rash\nAny unresolved grade 2 irAE\nAny toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy. Exception to the above: Toxicities of any grade that require replacement therapy and have stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed\nSTEP 2: RANDOMIZATION: History and physical exam must be obtained within 28 days prior to Step 2 randomization\nSTEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function and be considered class 2B or better on the New York Heart Association Functional Classification\nSTEP 2: RANDOMIZATION: Participants must have Zubrod performance status 0-2 documented within 28 days prior to Step 2 Randomization.\nSTEP 2: RANDOMIZATION: Leukocytes >= 3 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Absolute neutrophil count >= 1.5 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Platelets >= 100 x 10^3/mL (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Creatinine =< institutional ULN OR estimated creatinine clearance > 30 mL/min (within 28 days prior to Step 2 Randomization)\nSTEP 2: RANDOMIZATION: Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be able to swallow capsule whole\nSTEP 2: RANDOMIZATION: Participants with known diabetes must not have uncontrolled diabetes. (Uncontrolled diabetes is defined as glycosylated hemoglobin [HgA1C] > 7%)\nSTEP 2: RANDOMIZATION: Participants must not have any known clinically significant liver disease, including cirrhosis, fatty liver, or inherited liver disease\nSTEP 2: RANDOMIZATION: Participants must not have end stage renal or other serious medical illness that may limit survival or the ability to participate in this study\nSTEP 2: RANDOMIZATION: Participants must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\nSTEP 2: RANDOMIZATION: Participants must not have known active tuberculosis (TB)\nSTEP 2: RANDOMIZATION: Participants must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation\nSTEP 2: RANDOMIZATION: Participants must not have history of allergic reaction attributed to compounds of similar chemical or biological composition to atezolizumab and/or talazoparib\nSTEP 2: RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\nSTEP 2: RANDOMIZATION: Participants must not be on corticosteroids at doses greater than prednisone 10 mg daily or equivalent within 7 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not receive any live attenuated vaccines within 28 days prior to Step 2 Randomization or at any time during the study and until 5 months after the last dose of protocol treatment\nSTEP 2: RANDOMIZATION: Participants must not have severe infections in the form of severe sepsis or septic shock including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia within 14 days prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 7 months after the last dose of protocol treatment. A woman is considered to be of "reproductive potential" if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to Step 2 Randomization\nSTEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\nSTEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\nSTEP 2: RANDOMIZATION: As a part of the OPEN registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\nSTEP 2: RANDOMIZATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)'}

{'Arm - Disease - Indication': 'SLFN11-Positive Extensive-Stage Small Cell Lung Carcinoma'}

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

NCT01957436

{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': "Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials."}

{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'}

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

NCT01957436

{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': "Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials."}

{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'}

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

NCT01957436

{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': "Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials."}

{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'}

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

NCT01957436

{'Official Title': 'A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer', 'Brief Summary': 'This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.', 'Condition': 'Metastatic Prostate Cancer', 'Detailed Description': 'Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.\nThe randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.\nThe randomization will be stratified (by minimization) according to:\nenrolment center,\nperformance status (0 vs. 1-2)\ndisease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.\nCRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).\nWhen the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.\nInvestigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.\nAbiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.', 'Inclusion Criteria': "Inclusion criteria:\nHistologically or cytologically confirmed adenocarcinoma of the prostate,\nMetastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:\no At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm\nPatients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),\nLife expectancy of at least 6 months,\nMale aged ≥ 18 years old and ≤ 80 years old ,\nHematology values:\nHemoglobin ≥ 10.0 g/dL,\nPlatelet count ≥ 100,000/mL,\nNeutrophil ≥ 1500 cells/mm³\nBiochemistry values:\nRenal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,\nSerum potassium ≥ 4 mmol/L,\nLiver function:\nSerum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),\nAST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),\nALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)\nPatients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,\nPatients willing and clinically fit to receive Docetaxel which is defined by the following :\nPatients respecting all inclusion and exclusion criteria And\nPatients with no contraindication to docetaxel according to the SmPC of the drug And\nPatients presenting all medical requirements to receive docetaxel according to the investigator's opinion.\nPatients might have received previous radiation therapy directed to bone lesions,\nPatients able to take oral medication,\nPatients who have received the information sheet and signed the informed consent form,\nMale patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel\nPatients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\nPatients with a public or a private health insurance coverage, according to local laws for participation in clinical trials."}

{'Arm - Disease - Indication': 'Metastatic Hormone-naïve Prostate Cancer'}

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

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Biliary Tract Cancer'}

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

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Bladder Cancer'}

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

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Cervical Cancer'}

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

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Endometrial Cancer'}

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

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Ovarian Cancer'}

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

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Pancreatic Cancer'}

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

NCT04482309

{'Official Title': 'A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)', 'Brief Summary': 'This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.\nThis study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.\nStudy hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.', 'Condition': 'Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nLocally advanced, unresectable, or metastatic disease based on most recent imaging.\nThe respective cohorts for patient inclusion are:\nCohort 1: Biliary tract cancer\nCohort 2: Bladder cancer\nCohort 3: Cervical cancer\nCohort 4: Endometrial cancer\nCohort 5: Epithelial ovarian cancer\nCohort 6: Pancreatic cancer\nCohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.\nProgressed following prior treatment or who have no satisfactory alternative treatment option.\nPrior HER2 targeting therapy is permitted.\nHER2 expression for eligibility may be based on local or central assessment.\nHas measurable target disease assessed by the Investigator based on RECIST version 1.1.\nHas protocol- defined adequate organ function including cardiac, renal and hepatic function.'}

{'Arm - Disease - Indication': 'Locally Advanced Unresectable or Metastatic HER2-Expressing Rare Tumor'}

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

NCT03635567

{'Official Title': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.\nThe primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)\nNot pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab\nHas measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization\nHas adequate organ function'}

{'Arm - Disease - Indication': 'Adult First-Line Persistent Recurrent or Metastatic Cervical Cancer'}

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

NCT03635567

{'Official Title': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)', 'Brief Summary': 'The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.\nThe primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).', 'Condition': 'Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\nHas persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation)\nNot pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab\nHas measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology\nHas provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization\nHas an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization\nHas adequate organ function'}

{'Arm - Disease - Indication': 'Adult First-Line Persistent Recurrent or Metastatic Cervical Cancer'}

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

NCT03907488

{'Official Title': 'A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age &gt;/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma', 'Brief Summary': "This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.", 'Condition': 'Ann Arbor Stage III Hodgkin Lymphoma\nAnn Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Hodgkin Lymphoma\nAnn Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nClassic Hodgkin Lymphoma\nLymphocyte-Rich Classic Hodgkin Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin hydrochloride [doxorubicin], vinblastine sulfate [vinblastine], dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.\nII. To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.\nIII. To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.\nIV. To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.\nV. To compare patient-reported symptoms using selected Patient Reported Outcome Common Toxicity Criteria for Adverse Events (PRO-CTCAE) items between arms stratified by age groups.\nVI. To compare the safety and tolerability of N-AVD versus that of BV-AVD.\nQUALITY OF LIFE OBJECTIVE:\nI. To compare between arms patient-reported fatigue, neuropathy and health-related quality of life over time (baseline, beginning of cycle 3, 4-8 weeks after the last dose of protocol therapy [following last dose of study drug or radiation therapy, whichever is later], and 1 and 3 years after randomization) using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and the PROMIS Global, respectively.\nBANKING OBJECTIVES:\nI. To bank specimens for future correlative studies. II. To bank positron emission tomography (PET)-computed tomography (CT) images for future correlative studies.\nOUTLINE: Patients are randomized to 1 of 2 arms.\nARM I: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim subcutaneously (SC) on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and/or magnetic resonance imaging (MRI) on study.\nARM II: Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.\nAfter completion of study treatment and prior to disease progression, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration. Patients are followed up at the time of progression and then annually until 10 years after registration. Patients who receive radiation therapy are followed up at 8-12 weeks after completion of radiation therapy.', 'Inclusion Criteria': 'Inclusion Criteria:\nAll patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible.\nPatients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave.\nPatients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, MRI or MR-PET is acceptable in event that PET-CT is contra-indicated, however if it is later possible to administer a PET-CT, then PET-CT is strongly preferred for the interim scan (after cycle 2) (if performed) and the EOT assessment. Otherwise, if PET-CT is not subsequently possible, then the same modality as baseline must be used throughout the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted.\nPatients must be >= 12 years of age.\nPatients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted.\nPatients must not have had prior solid organ transplant.\nPatients must not have had prior allogeneic stem cell transplantation.\nPatients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid).\nAt registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator\'s intent-to-treat with residual PET RT.\nAll pediatric patients (< 18 years of age) will be considered intent-to-treat with Residual PET RT at time of registration.\nPatients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients =< 17 years of age. *The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only.\nAdults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight.\nPediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration:\nMeasured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or\nSerum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows:\nAge < 13 maximum serum creatinine: Male 1.2 mg/dL; Female 1.2 mg/dL\nAge 13 to < 16 maximum serum creatinine: Male 1.5 mg/dL; Female 1.4 mg/dL\nAge 16-17 maximum serum creatinine: Male 1.7 mg/dL; Female 1.4 mg/dL\nTotal bilirubin =< 2 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nPatients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction >= 50% or a shortening fraction of >= 27%. For all patients, the ECHO, MUGA, or functional cardiac imaging scan must be performed within 42 days prior to registration.\nPatients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable or unquantifiable viral load at their most recent viral load test within 6 months prior to registration.\nPatients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load within 6 months prior to registration and no residual hepatic impairment are eligible.\nPatients must not have any known central nervous system lymphoma.\nPatients must not have a history of or active interstitial pneumonitis or interstitial lung disease.\nPatients must not have had a diagnosis of inherited or acquired immunodeficiency.\nPatients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\nPatients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1.\nPatients with peripheral neuropathy must have < grade 2 at date of registration.\nPatients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn\'s disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener\'s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.\nNo second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years.\nFemales of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.\nPatients must have one formalin-fixed paraffin embedded (FFPE) diagnostic tumor block or at least 1 diagnostic, 4-5 micron, hematoxylin and eosin (H&E) slide collected prior to registration and available for submission.\nPatients must be offered participation in banking for planned translational medicine and future research. With patient consent, any residuals from the mandatory tissue submission will also be banked for future research.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must complete the PROMIS Fatigue, the FACT/GOG-Ntx, and the PROMIS Global prior to registration.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must also agree to complete the PROMIS Fatigue, the FACT/GOG-Ntx, the PROMIS Global, and the PRO-CTCAE (or Pediatric [Ped] PRO-CTCAE) at the scheduled on-study assessment timepoints.\nPatients must be informed of the investigational nature of this study and all patients and/or their parents or legal guardians (for patients < 18 years of age) must sign and give informed consent and assent (where appropriate) in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board Initiative (CIRB) regulations.'}

{'Arm - Disease - Indication': 'Newly Diagnosed Previously Untreated Advanced Stage III Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Classical Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Lymphocyte-Rich Classic Hodgkin Lymphoma'}

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

NCT03907488

{'Official Title': 'A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age &gt;/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma', 'Brief Summary': "This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.", 'Condition': 'Ann Arbor Stage III Hodgkin Lymphoma\nAnn Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Hodgkin Lymphoma\nAnn Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nAnn Arbor Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nClassic Hodgkin Lymphoma\nLymphocyte-Rich Classic Hodgkin Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\nI. To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin hydrochloride [doxorubicin], vinblastine sulfate [vinblastine], dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).\nSECONDARY OBJECTIVES:\nI. To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.\nII. To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.\nIII. To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.\nIV. To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.\nV. To compare patient-reported symptoms using selected Patient Reported Outcome Common Toxicity Criteria for Adverse Events (PRO-CTCAE) items between arms stratified by age groups.\nVI. To compare the safety and tolerability of N-AVD versus that of BV-AVD.\nQUALITY OF LIFE OBJECTIVE:\nI. To compare between arms patient-reported fatigue, neuropathy and health-related quality of life over time (baseline, beginning of cycle 3, 4-8 weeks after the last dose of protocol therapy [following last dose of study drug or radiation therapy, whichever is later], and 1 and 3 years after randomization) using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx), and the PROMIS Global, respectively.\nBANKING OBJECTIVES:\nI. To bank specimens for future correlative studies. II. To bank positron emission tomography (PET)-computed tomography (CT) images for future correlative studies.\nOUTLINE: Patients are randomized to 1 of 2 arms.\nARM I: Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim subcutaneously (SC) on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and/or magnetic resonance imaging (MRI) on study.\nARM II: Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.\nAfter completion of study treatment and prior to disease progression, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, then annually until 10 years after registration. Patients are followed up at the time of progression and then annually until 10 years after registration. Patients who receive radiation therapy are followed up at 8-12 weeks after completion of radiation therapy.', 'Inclusion Criteria': 'Inclusion Criteria:\nAll patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible.\nPatients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave.\nPatients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, MRI or MR-PET is acceptable in event that PET-CT is contra-indicated, however if it is later possible to administer a PET-CT, then PET-CT is strongly preferred for the interim scan (after cycle 2) (if performed) and the EOT assessment. Otherwise, if PET-CT is not subsequently possible, then the same modality as baseline must be used throughout the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted.\nPatients must be >= 12 years of age.\nPatients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted.\nPatients must not have had prior solid organ transplant.\nPatients must not have had prior allogeneic stem cell transplantation.\nPatients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid).\nAt registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator\'s intent-to-treat with residual PET RT.\nAll pediatric patients (< 18 years of age) will be considered intent-to-treat with Residual PET RT at time of registration.\nPatients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients =< 17 years of age. *The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only.\nAdults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight.\nPediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration:\nMeasured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or\nSerum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows:\nAge < 13 maximum serum creatinine: Male 1.2 mg/dL; Female 1.2 mg/dL\nAge 13 to < 16 maximum serum creatinine: Male 1.5 mg/dL; Female 1.4 mg/dL\nAge 16-17 maximum serum creatinine: Male 1.7 mg/dL; Female 1.4 mg/dL\nTotal bilirubin =< 2 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).\nUnless due to Gilbert\'s disease, lymphomatous involvement of liver or vanishing bile duct syndrome\nPatients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction >= 50% or a shortening fraction of >= 27%. For all patients, the ECHO, MUGA, or functional cardiac imaging scan must be performed within 42 days prior to registration.\nPatients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable or unquantifiable viral load at their most recent viral load test within 6 months prior to registration.\nPatients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load within 6 months prior to registration and no residual hepatic impairment are eligible.\nPatients must not have any known central nervous system lymphoma.\nPatients must not have a history of or active interstitial pneumonitis or interstitial lung disease.\nPatients must not have had a diagnosis of inherited or acquired immunodeficiency.\nPatients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\nPatients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1.\nPatients with peripheral neuropathy must have < grade 2 at date of registration.\nPatients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn\'s disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener\'s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.\nNo second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years.\nFemales of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.\nPatients must have one formalin-fixed paraffin embedded (FFPE) diagnostic tumor block or at least 1 diagnostic, 4-5 micron, hematoxylin and eosin (H&E) slide collected prior to registration and available for submission.\nPatients must be offered participation in banking for planned translational medicine and future research. With patient consent, any residuals from the mandatory tissue submission will also be banked for future research.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must complete the PROMIS Fatigue, the FACT/GOG-Ntx, and the PROMIS Global prior to registration.\nPatients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must also agree to complete the PROMIS Fatigue, the FACT/GOG-Ntx, the PROMIS Global, and the PRO-CTCAE (or Pediatric [Ped] PRO-CTCAE) at the scheduled on-study assessment timepoints.\nPatients must be informed of the investigational nature of this study and all patients and/or their parents or legal guardians (for patients < 18 years of age) must sign and give informed consent and assent (where appropriate) in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board Initiative (CIRB) regulations.'}

{'Arm - Disease - Indication': 'Newly Diagnosed Previously Untreated Advanced Stage III Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage III Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Lymphocyte-Depleted Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Mixed Cellularity Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Stage IV Nodular Sclerosis Classic Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Classical Hodgkin Lymphoma\nNewly Diagnosed Previously Untreated Advanced Lymphocyte-Rich Classic Hodgkin Lymphoma'}

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

NCT03391466

{'Official Title': 'A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma', 'Brief Summary': 'The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).', 'Condition': 'Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)', 'Detailed Description': 'This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy. After completing the treatment period, all subjects will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, subjects who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968.', 'Inclusion Criteria': 'Key Inclusion Criteria:\nHistologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016)\nDLBCL not otherwise specified (ABC/GCB)\nHGBL with or without MYC and BCL2 and/or BCL6 rearrangement\nDLBCL arising from FL\nT-cell/histiocyte rich large B-cell lymphoma\nDLBCL associated with chronic inflammation\nPrimary cutaneous DLBCL, leg type\nEpstein-Barr virus (EBV) + DLBCL\nRelapsed or refractory disease after first-line chemoimmunotherapy\nRefractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded.\nProgressive disease (PD) as best response to first-line therapy\nStable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\nPartial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 12 months of therapy\nRelapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy\nIndividuals must have received adequate first-line therapy including at a minimum:\nAnti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\nAn anthracycline containing chemotherapy regimen\nNo known history or suspicion of central nervous system involvement by lymphoma\nEastern cooperative oncology group (ECOG) performance status of 0 or 1\nAdequate bone marrow function as evidenced by:\nAbsolute neutrophil count (ANC) ≥ 1000/uL\nPlatelet ≥ 75,000/uL\nAbsolute lymphocyte count ≥ 100/uL\nAdequate renal, hepatic, cardiac, and pulmonary function as evidenced by:\nCreatinine clearance (Cockcroft Gault) ≥ 60 mL/min\nSerum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN)\nTotal bilirubin ≤ 1.5 mg/dl\nCardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\nNo clinically significant pleural effusion\nBaseline oxygen saturation > 92% on room air'}

{'Arm - Disease - Indication': 'Adult Second-Line Relapsed/Refractory Diffuse Large B Cell Lymphoma'}

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

NCT03391466

{'Official Title': 'A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma', 'Brief Summary': 'The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).', 'Condition': 'Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)', 'Detailed Description': 'This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy. After completing the treatment period, all subjects will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, subjects who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968.', 'Inclusion Criteria': 'Key Inclusion Criteria:\nHistologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016)\nDLBCL not otherwise specified (ABC/GCB)\nHGBL with or without MYC and BCL2 and/or BCL6 rearrangement\nDLBCL arising from FL\nT-cell/histiocyte rich large B-cell lymphoma\nDLBCL associated with chronic inflammation\nPrimary cutaneous DLBCL, leg type\nEpstein-Barr virus (EBV) + DLBCL\nRelapsed or refractory disease after first-line chemoimmunotherapy\nRefractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded.\nProgressive disease (PD) as best response to first-line therapy\nStable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\nPartial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 12 months of therapy\nRelapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy\nIndividuals must have received adequate first-line therapy including at a minimum:\nAnti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\nAn anthracycline containing chemotherapy regimen\nNo known history or suspicion of central nervous system involvement by lymphoma\nEastern cooperative oncology group (ECOG) performance status of 0 or 1\nAdequate bone marrow function as evidenced by:\nAbsolute neutrophil count (ANC) ≥ 1000/uL\nPlatelet ≥ 75,000/uL\nAbsolute lymphocyte count ≥ 100/uL\nAdequate renal, hepatic, cardiac, and pulmonary function as evidenced by:\nCreatinine clearance (Cockcroft Gault) ≥ 60 mL/min\nSerum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN)\nTotal bilirubin ≤ 1.5 mg/dl\nCardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\nNo clinically significant pleural effusion\nBaseline oxygen saturation > 92% on room air'}

{'Arm - Disease - Indication': 'Adult Second-Line Relapsed/Refractory Diffuse Large B Cell Lymphoma'}

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

NCT03936270

{'Official Title': 'Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer.', 'Brief Summary': 'The primary objective of this study is to evaluate 12 weeks progression-free survival (PFS) rate of Palbociclib plus Letrozole in ER/PR positive endometrioid or high-grade serous ovarian cancer who have disease progression on second-line chemotherapy.', 'Condition': 'Ovarian Cancer', 'Detailed Description': 'Letrozole (Femara®) is an oral non-steroidal aromatase inhibitor that is approved worldwide for the treatment of postmenopausal women with breast cancer. It is administered orally on a continuous 2.5 mg daily dosing regimen and has a good toxicity profile. Palbociclib (Ibrance®) is an active potent and highly selective reversible inhibitor of cyclin- dependent kinases 4 and 6 (CDK4/6). Palbociclib was approved by the United States Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor based on a randomized, double-blind, placebo-controlled, international clinical trial PALOMA-2. It is administered orally on a dose of 125 mg per day in 4-week cycles (3 weeks of treatment followed by 1 week off). This trial was based on preclinical studies that showed a synergistic effect between targeting the ER and cyclin-D-CDK4/6-Rb pathway. The principal toxicity was myelotoxicity but it was managed with appropriate supportive care and dose reductions13.\n\nBased on the results of phase 1 and 2 clinical trials of CDK4/6 inhibitors used as monotherapy to treat patients with recurrent ovarian cancer, we hypothesized that, as Palbociclibe is active in this population and many ovarian cancer show ER/PR expression, its combination with Letrozole can improve outcomes in ER/PR positive endometrioid or high-grade serous Ovarian Cancer who have disease progression on second-line chemotherapy, similar to what is seen in breast cancer studies.', 'Inclusion Criteria': "Inclusion Criteria:\n\nEvidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;\nSubject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;\n18 years of age or older;\nPatient agrees not to participate in another interventional study while on treatment;\nHistology confirmed ovarian cancer serous or endometrioid high degree, fallopian tube or with locoregional recurrence peritoneum (not amenable to curative treatment) or metastatic;\nEstrogen (ER) and/or progesterone (RP) receptor positive tumor, defined as > 10% by immunohistochemical examination in the local laboratory;\nAvailability of tumor sample from the primary tumor or metastasis, fixed in formalin and embedded in paraffin, for confirmation of positivity for ER and/or RP in a central laboratory;\nDisease measurable by RECIST 1.1 as assessed by the local investigator or radiologist;\nPatients must have chemotherapy application for recurrence locoregional or metastatic according to the following criteria:\n\nat least one platinum-based chemotherapy regimen;\nhave confirmed no more than 3 chemotherapy regimens for locally advanced or metastatic disease\nPatient must have radiographic disease progression to last treatment;\nFunctional capacity by the Eastern Cooperative Oncology Group (ECOG) ≤ 2;\nAdequate bone marrow function:\n\nAbsolute neutrophil count (CAN) ≥ 1,500/mm3 (≥ 1.5x109/L)\nPlates ≥ 100,000/mm3 or ≥ 100 x 109/L\nHemoglobin ≥ 9.0 g/dL;\n12. Adequate liver function:\n\nTotal serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 3.0 x ULN if there is Gilbert's Syndrome)\nAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (≤ 5.0 x ULN if liver tumor was involved)\nAlkaline phosphatase ≤ 2.5 x ULN (≤ 5.0 x ULN if any liver tumor involvement); 13. Adequate kidney function:\nEstimated creatinine clearance ≥ 15 mL/min; 14. Evidence of lack of potential to become pregnant:\nPost-menopause (defined as at least 1 year without menstruation) before selection, or\nRadiotherapy-induced oophorectomy with the last menstruation > 1 year ago, or\nSurgical sterilization (bilateral oophorectomy or hysterectomy)."}

{'Arm - Disease - Indication': 'PR-Positive ER-Positive Previously Treated Metastatic High Grade Serous Ovarian Cancer\nPR-Positive ER-Positive Previously Treated Metastatic Endometrioid Ovarian Cancer\nPR-Positive ER-Positive Previously Treated Metastatic Fallopian Tube Cancer\nPR-Positive ER-Positive Previously Treated Metastatic Locoregionally Recurrent Peritoneal Cancer'}

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

NCT04626791

{'Official Title': 'A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma', 'Brief Summary': 'This phase II trial investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Modified VR-CAP is a combination of drugs used as standard first line treatment for mantle cell lymphoma. Chemotherapy drugs, such as bortezomib, cyclophosphamide, doxorubicin hydrochloride, and cytarabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that binds and depletes malignant B cells, by inducing immune responses and direct toxicity. Acalabrutinib blocks a key enzyme which is needed for malignant cell growth in mantle cell lymphoma. Combining modified VR-CAP and acalabrutinib as first line therapy may be more useful against mantle cell lymphoma compared to the usual treatment.', 'Condition': 'Mantle Cell Lymphoma', 'Detailed Description': 'PRIMARY OBJECTIVE:\r\n\r\nI. To determine the proportion of complete metabolic responses according to Lugano criteria at the end of study therapy.\r\n\r\nSECONDARY OBJECTIVES:\r\n\r\nI. To evaluate the safety of this regimen. II. To determine the proportion of subjects proceeding to autologous stem cell transplant (ASCT).\r\n\r\nIII. To determine the feasibility and results of stem cell mobilization and successful collection.\r\n\r\nIV. To determine the progression-free survival (PFS) and overall survival (OS) (event monitoring phase), assessed up to 2 years after registration.\r\n\r\nCORRELATIVE RESEARCH OBJECTIVE:\r\n\r\nI. To assess minimal residual disease level after 3 and 6 cycles of therapy using the ClonoSEQ (Adaptive Biotechnologies, Seattle, Washington [WA]), and to explore the relationship between radiographic complete response (CR) rate and baseline features.\r\n\r\nOUTLINE:\r\n\r\nCYCLES 1, 3, AND 5: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-21. Patients also receive bortezomib subcutaneously (SC) on days 1, 8, and 15, rituximab (or rituximab and hyaluronidase human) intravenously (IV), cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1, and prednisone PO on days 1-5.\r\n\r\nCYCLES 2, 4, AND 6: Patients receive acalabrutinib PO BID on days 1-21. Patients also receive rituximab (or rituximab and hyaluronidase human) IV on day 1 and cytarabine IV on days 1-2.\r\n\r\nTreatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.\r\n\r\nAfter completion of study treatment, patients are followed up every 6 months for up to 2 years after registration.', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nAge 18-75 years\r\nNo prior therapy for mantle cell lymphoma (MCL)\r\nMCL in need of systemic therapy, and potentially eligible for ASCT as assessed by the treating physician\r\nDocumented histological confirmation of MCL by local institutional review\r\nDocumented, fludeoxyglucose F-18 (FDG)-avid measurable disease (at least 1 lesion >= 1.5 cm in diameter) as detected by positron emission tomography (PET)/computed tomography (CT) and as defined and includes measurable nodal and extranodal disease sites, or splenomegaly measuring more than 13 cm in vertical length\r\nEastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2\r\nAbsolute neutrophil count (ANC) >= 1000/mm^3 or >= 500/mm^3 if due to lymphomatous marrow or spleen involvement (obtained =< 30 days prior to registration)\r\nPlatelet count >= 100,000/mm^3 or >= 75,000/mm^3 if due to lymphomatous marrow or spleen involvement (obtained =< 30 days prior to registration)\r\nTotal bilirubin =< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome, for which total bilirubin =< 3 x upper limit of normal [ULN] is permitted) (obtained =< 30 days prior to registration)\r\nAspartate transaminase (AST) =< 3 x ULN (obtained =< 30 days prior to registration)\r\nProthrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) =< 2 x ULN, unless elevated due to a lupus anticoagulant (obtained =< 30 days prior to registration)\r\nCalculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula (obtained =< 30 days prior to registration)\r\nNegative pregnancy test done within =< 14 days prior to registration for women of childbearing potential only\r\nFor women of childbearing potential (WOCBP, defined as premenopausal women capable of becoming pregnant): Must agree to use of highly effective method of birth control during study therapy and until 12 months after last dose of study therapy. NOTE: 'Acceptable' methods are not adequate. Highly effective methods are defined by Clinical Trials Facilitation and Coordination Group [CTFG] as having a failure rate of < 1% per year\r\nMen must agree to use barrier contraception starting with the first dose of study therapy and through 180 days after completion of study therapy\r\nProvide informed written consent\r\nWilling to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\r\nHematologic labs must be obtained within =< 14 days of registration\r\nWilling and able to participate in all required evaluations and procedures in this study protocol\r\nAbility to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information"}

{'Arm - Disease - Indication': 'First-Line Mantle Cell Lymphoma'}

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

NCT03627728

{'Official Title': 'Phase II Randomized Study of Maintenance Regorafenib vs Placebo in no Progression Patients After First-line Platinum and Fluoropyrimidines Based Chemotherapy in HER2 Negative Locally Advanced/Metastatic Gastric or Gastroesophagel Junction Cancer (a-MANTRA Study)', 'Brief Summary': 'Randomized, double-blind, placebo-controlled, multicenter Phase-II study.\r\n\r\nApproximately 120 subjects with CR/PR/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups:\r\n\r\nArm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale of female ≥ 18 years of age\r\nHave an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment\r\nDiagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\r\nHER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -)\r\nLocally advanced/metastatic gastric or gastroesophageal junction cancer\r\nCR/PR/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy\r\nMeasurable disease according to RECIST 1.1 criteria\r\nHave adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:\r\nTotal bilirubin 1.5 times the upper limit of normal (ULN)\r\nAlanine aminotransferase and aspartate aminotransferase 3 times the ULN\r\nLipase 1.5 times the ULN\r\nSerum creatinine 1.5 times the ULN\r\nGlomerular filtration rate 30 mL/min/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula\r\nInternational normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.\r\nPlatelet count 100,000 /mm3, hemoglobin 9 g/dL, absolute neutrophil count 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors\r\nAlkaline phosphatase ≤ 2.5 times the ULN\r\nUnderstand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure.\r\nIf female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.\r\nIf female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.'}

{'Arm - Disease - Indication': 'Locally advanced metastatic gastric or gastroesophageal junction cancer'}

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

NCT03627728

{'Official Title': 'Phase II Randomized Study of Maintenance Regorafenib vs Placebo in no Progression Patients After First-line Platinum and Fluoropyrimidines Based Chemotherapy in HER2 Negative Locally Advanced/Metastatic Gastric or Gastroesophagel Junction Cancer (a-MANTRA Study)', 'Brief Summary': 'Randomized, double-blind, placebo-controlled, multicenter Phase-II study.\r\n\r\nApproximately 120 subjects with CR/PR/SD after platinum compounds and fluoropyrimidines based regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the following treatment groups:\r\n\r\nArm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4 weeks, until intolerance or progression disease Primary Variable: PFS1', 'Condition': 'Gastric Cancer', 'Detailed Description': '-', 'Inclusion Criteria': 'Inclusion Criteria:\r\n\r\nMale of female ≥ 18 years of age\r\nHave an Eastern Cooperative Oncology Group performance status of 0 or 1 within 14 days prior to the initiation of study treatment\r\nDiagnosis of histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\r\nHER2 negative gastric or gastroesophagel junction cancer ( ICH 0, IHC 1+, IHC + FISH -)\r\nLocally advanced/metastatic gastric or gastroesophageal junction cancer\r\nCR/PR/SD after first-line platinum compound and Fluoropyrimidines based chemotherapy\r\nMeasurable disease according to RECIST 1.1 criteria\r\nHave adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:\r\nTotal bilirubin 1.5 times the upper limit of normal (ULN)\r\nAlanine aminotransferase and aspartate aminotransferase 3 times the ULN\r\nLipase 1.5 times the ULN\r\nSerum creatinine 1.5 times the ULN\r\nGlomerular filtration rate 30 mL/min/1,73 m2 according to the Modified Diet in Renal Disease abbreviated formula\r\nInternational normalized ratio of prothrombin time and activated partial thromboplastin time 1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.\r\nPlatelet count 100,000 /mm3, hemoglobin 9 g/dL, absolute neutrophil count 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors\r\nAlkaline phosphatase ≤ 2.5 times the ULN\r\nUnderstand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure.\r\nIf female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.\r\nIf female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.'}

{'Arm - Disease - Indication': 'Locally advanced metastatic gastric or gastroesophageal junction cancer'}

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

NCT04590599

{'Official Title': 'A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy', 'Brief Summary': 'This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy', 'Condition': 'Advanced Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nThe subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.\r\nAged ≥18 years and ≤75 years.\r\nDiagnosed with cervical cancer by histology/cytology.\r\nPatients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).\r\nThe subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue)."}

{'Arm - Disease - Indication': 'Advanced Relapsed or Metastatic Cervical Cancer'}

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

NCT04590599

{'Official Title': 'A Randomized, Double-blind, Controlled, Parallel-cohort Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy', 'Brief Summary': 'This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy', 'Condition': 'Advanced Cervical Cancer', 'Detailed Description': '-', 'Inclusion Criteria': "Inclusion Criteria:\r\n\r\nThe subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.\r\nAged ≥18 years and ≤75 years.\r\nDiagnosed with cervical cancer by histology/cytology.\r\nPatients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).\r\nThe subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue)."}

{'Arm - Disease - Indication': 'Advanced Relapsed or Metastatic Cervical Cancer'}