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

Inclusion criteria

• ✓. Signed informed consent form.
• ✓. Age ≥ 18 years.
• ✓. Patients must have histologically or cytologically confirmed progressive metastatic or recurrent solid tumor (as defined below for each tumor type). Diagnosis must be stated in a pathology report and confirmed by the investigator.
• ✓. To be enrolled in this study, only the tumor types and settings described below are allowed:
• ✓.1 - Cohorts 1 A-D: 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.
• ✓.1.1 - Cohort 1A: Non Small Cell Lung Cancer 4.1.2 - Cohort 1B: Urothelial Bladder Cancer 4.1.3 - Cohort 1C: metastatic Castration Resistant Prostate Cancer (mCRPC) 4.1.4 - Cohort 1D: Others 4.2 - Cohorts 2A-C: Platinum-sensitive disease 4.2.1 - Cohort 2A: Non Small Cell Lung Cancer 4.2.2 - Cohort 2B: Urothelial Bladder Cancer 4.2.3 - Cohort 2C: Gastric or gastro-esophageal junction adenocarcinoma 4.3 - Cohort 3: Metastatic Castration Resistant Prostate Cancer (mCRPC) 4.4 - Cohort 4: Clear cell Renal Cell Carcinoma
• ✓. Representative archival formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or 20 freshly cut and unstained slides, with an associated pathology report, for ancillary studies and central testing, is mandatory for all cohorts. In all cases, recovery of the most recent tumor block or biopsy is encouraged and tumor tissue has to date back from less than 3 years ago (less than 6 years for cohort 4). Cohorts 1 and 2: if tumor tissue is more than 3 years old, a fresh tumor biopsy is mandatory. Cohort 4: if tumor tissue is more than 6 years old, a fresh tumor biopsy is mandatory.
• ✓. Measurable disease, defined as: