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

Phase 2

Suspended

• Conditions: Solid Tumor
• Interventions: Drug: Atezolizumab; Drug: Rucaparib

• Registration Number: NCT04276376
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-12
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1A-D	Atezolizumab	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
Cohort 4	Atezolizumab	Clear Cell Renal Cell Carcinoma
Cohort 2A-C	Atezolizumab	Platinum-sensitive disease 2.A - Non-Small Cell Lung Cancer 2.B - Urothelial Bladder Cancer 2.C - Gastric or gastro-esophageal junction adenocarcinoma
Cohort 1A-D	Rucaparib	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
Cohort 3	Rucaparib	Metastatic Castration Resistant Prostate Cancer (mCRPC)
Cohort 4	Rucaparib	Clear Cell Renal Cell Carcinoma
Cohort 2A-C	Rucaparib	Platinum-sensitive disease 2.A - Non-Small Cell Lung Cancer 2.B - Urothelial Bladder Cancer 2.C - Gastric or gastro-esophageal junction adenocarcinoma
Cohort 3	Atezolizumab	Metastatic Castration Resistant Prostate Cancer (mCRPC)

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	at 12 weeks

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France