drugset / Trial / NCT05126342

Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi

NCT05126342

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, non-randomized pilot study (Phase II). The aim is to obtain evidence of efficacy of niraparib and dostarlimab (TSR-042) in patients with relapsed ovarian cancer in two experimental cohorts and to generate data on PARPi (Poly(ADP-ribose)-Polymerase inhibitor) resistance and predictive biomarkers for IO (Immuno-Oncology) and PARPi.

Timeline

Start
2023-11-01
Primary completion
2024-11-01
Completion
2026-11-01

Drugs

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