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A phase 3 trial of Niraparib and Dostarlimab in ovarian cancer, run by Tesaro, Inc., active and no longer recruiting.
A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer is a phase 3 interventional study registered as NCT03602859 by Tesaro, Inc., with 1400 participants enrolled, started 2018-10-11 and due to reach its primary completion in 2024-10-31. Interventions recorded: Niraparib, Dostarlimab (TSR-042), Standard of care, Dostarlimab-Placebo and Niraparib-Placebo. Results have been posted on the registry.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,400 enrolled.
95% CI 16.59 to 20.99; Figures from the ClinicalTrials.gov results section (first posted 2025-12-31), not from a publication · 95% CI 19.22 to 22.77
Source95% CI 40.28 to 52.21; Figures from the ClinicalTrials.gov results section (first posted 2025-12-31), not from a publication · 95% CI 41.17 to 47.54
Source95% CI 83.7 to 91.6; Figures from the ClinicalTrials.gov results section (first posted 2025-12-31), not from a publication · 95% CI 85.5 to 90.9
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression Free Survival (PFS)primary | Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2) | 385 | 19.19 months | 0.85 (0.73 to 0.99) | 0.0351 | link |
| Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | 753 | 20.63 months | ||||
| Overall Survival (OS) | Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2) | 385 | 45.37 months | - | - | link |
| Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | 753 | 44.39 months | ||||
| Objective Response Rate (ORR) | Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2) | 385 | 88% | - | - | link |
| Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3) | 753 | 88.4% |
Shares Niraparib, GSK, PARP inhibitors, Ovarian cancer and the tag pipeline.
Shares Niraparib, GSK, PARP inhibitors and the tag pipeline.
Shares Dostarlimab, GSK and the tag pipeline.
Shares Dostarlimab, GSK and the tag pipeline.
Shares Dostarlimab, GSK and the tag pipeline.
Shares Dostarlimab, GSK and the tag pipeline.
Shares Dostarlimab, GSK and the tag pipeline.
Shares Dostarlimab, GSK and the tag pipeline.