A Multicenter, Open Label, Phase II Basket Trial Exploring the Efficacy and Safety of the Combination of Rucaparib (PARP Inhibitor) and Atezolizumab (Anti-PD-L1 Antibody) in Patients With DNA Repair-deficient or Platinum-sensitive Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
The primary objective of the trial is to evaluate the antitumor activity of atezolizumab and rucaparib in patients with selected advanced solid tumors as measured by the Overall Response Rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1A-D
Molecularly selected cohorts that harbor DNA repair deficiency, defined as bi-allelic loss-of-function alteration (mutation and/or deletion) in at least one of the following genes: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, PALB2, RAD51C, RAD51D, FANCA, NBN, RAD51, RAD54L.
1.A - Non-Small Cell Lung Cancer
1.B - Urothelial Bladder Cancer
1.C - metastatic Castration Resistant Prostate Cancer
1.D - others: any histology, excepted breast cancer or serous ovarian cancer
干预措施: Atezolizumab (Drug)
Cohort 1A-D
Molecularly selected cohorts that harbor DNA repair deficiency, defined as bi-allelic loss-of-function alteration (mutation and/or deletion) in at least one of the following genes: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, PALB2, RAD51C, RAD51D, FANCA, NBN, RAD51, RAD54L.
1.A - Non-Small Cell Lung Cancer
1.B - Urothelial Bladder Cancer
1.C - metastatic Castration Resistant Prostate Cancer
1.D - others: any histology, excepted breast cancer or serous ovarian cancer
干预措施: Rucaparib (Drug)
Cohort 2A-C
Platinum-sensitive disease 2.A - Non-Small Cell Lung Cancer 2.B - Urothelial Bladder Cancer 2.C - Gastric or gastro-esophageal junction adenocarcinoma
干预措施: Atezolizumab (Drug)
Cohort 2A-C
Platinum-sensitive disease 2.A - Non-Small Cell Lung Cancer 2.B - Urothelial Bladder Cancer 2.C - Gastric or gastro-esophageal junction adenocarcinoma
干预措施: Rucaparib (Drug)
Cohort 3
Metastatic Castration Resistant Prostate Cancer (mCRPC)
干预措施: Atezolizumab (Drug)
Cohort 3
Metastatic Castration Resistant Prostate Cancer (mCRPC)
干预措施: Rucaparib (Drug)
Cohort 4
Clear Cell Renal Cell Carcinoma
干预措施: Atezolizumab (Drug)
Cohort 4
Clear Cell Renal Cell Carcinoma
干预措施: Rucaparib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: at 12 weeks
次要结局
未报告次要终点