Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT04779151
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Dostarlimab — DRUG
    Substance: immunoglobulin G4 (IgG4) humanized monoclonal antibody (mAb) that binds with high affinity to PD-1 Manufacturer: Tesaro Inc. Dose: 500 mg every 21 days for the first 4 cycles, followed by 1,000 mg every 42 days cycle (ie, Q6W)
  • Niraparib — DRUG
    Substance: Inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) Manufacturer: Tesaro Inc. Dose: Flat-fixed dose (if \<77kg or platelets \<150,000 μL: 200mg; if \>/=77kg and platelets \>/= 150,000μL: 300mg)

Study Details

Treatment will consist of a PARP inhibitor (niraparib) monotherapy priming period (cycle 0; 21 days); an anti-PD-1 antibody (Dostarlimab ; TSR-042) will then be added from C1D1 every 21 days in combination for the first 4 cycles, and then every 42 days. Disease will be assessed every 2 cycles (6 weeks) from C3D1 by CT-scan (or MRI or bone scan, if relevant). Patients still under treatment after 1 year may have tumor evaluation spaced out every 3 cycles

Key Dates

Start date
Apr 7, 2021
Status verified
Nov 2025
Primary completion
Feb 25, 2025
Completion
Feb 25, 2025

Study Design

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

Arms

  • Experimental: 1.A - Urothelial Bladder Cancer
  • Experimental: 1.B - Gastric or gastro-esophageal junction adenocarcinoma
  • Experimental: 1.C - Head and Neck Cancer
  • Experimental: 1.D - Biliary Tract Cancer and pancreatic ductal adenocarcinoma (PDAC)
  • Experimental: 1.E - Others: any histology, excepted breast cancer, prostate cancer or serous ovarian cancer
  • Experimental: Cohort 2 - Platinum-sensitive urothelial bladder cancer
  • Experimental: Cohort 3 - Clear Cell Renal Cell Carcinoma

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: at 15 weeks ]

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