drugset / Trial / NCT04779151
Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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
Timeline
- Start
- 2021-04-07
- Primary completion
- 2025-02-25
- Completion
- 2025-02-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dostarlimab | Monoclonal antibody | 1000 mg | — |
| Subject | Niraparib | Small molecule | 200 mg | — |
| Subject | Niraparib | Small molecule | 300 mg | — |