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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT04276376
Phase
PHASE2
Status
Terminated

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Fc-engineered, humanized, Ig G1 monoclonal antibody against PDL-1 1200mg q3w
  • Rucaparib — DRUG
    Inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) 600mg BID

Study Details

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

Key Dates

Start date
Apr 12, 2019
Status verified
Nov 2025
Primary completion
Jan 25, 2023
Completion
Dec 12, 2023

Study Design

Enrollment
130 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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
  • Experimental: Cohort 3
    Metastatic Castration Resistant Prostate Cancer (mCRPC)
  • Experimental: Cohort 4
    Clear Cell Renal Cell Carcinoma

Primary Outcome Measure

Overall Response Rate [ Time Frame: at 12 weeks ]

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