drugset / Trial / NCT03955471

Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer

NCT03955471

Phase 2 Terminated 41 enrolled Tesaro, Inc. Gynecologic Oncology Group · collab
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and dostarlimab (TSR-042) in participants with advanced, relapsed, high-grade ovarian, fallopian tube, endometrioid, clear cell ovarian or primary peritoneal cancer without known breast cancer susceptibility gene (BRCA) mutation who have platinum-resistant disease and who have also been previously treated with bevacizumab.

Timeline

Start
2019-10-03
Primary completion
2021-08-18
Completion
2022-01-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dostarlimab Monoclonal antibody 1000 mg Intravenous
Subject Niraparib Small molecule 200 mg Oral
Subject Niraparib Small molecule 300 mg Oral

Indications