drugset / Trial / NCT04679064
Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment
Phase 3
Unknown
427 enrolled
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
GlaxoSmithKline · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician's choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option
Timeline
- Start
- 2020-12-01
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | — | — |
| Subject | Dostarlimab | Monoclonal antibody | 1000 mg | — |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Niraparib | Small molecule | 200 mg | Oral |
| Subject | Niraparib | Small molecule | 300 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Comparator | Pegylated liposomal doxorubicin | Unknown | 40 mg/m2 | Intravenous |
| Comparator | Topotecan | Small molecule | 1.25 mg/m2 | — |