{"entity":{"id":"nct03602859","kind":"trial","name":"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","aka":[],"tldr":"A phase 3 trial of Niraparib and Dostarlimab in ovarian cancer, run by Tesaro, Inc., active and no longer recruiting.","summary":"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.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03602859","url":"https://clinicaltrials.gov/study/NCT03602859"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":["parp-inhibitor"],"targets":[],"drugs":["niraparib","dostarlimab"],"companies":["gsk"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03602859","phase":"3","setting":"A Randomized, Double-blind, Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer","sponsor":"Tesaro, Inc.","started":"2018-10-11","startedType":"actual","yearReported":2025,"enrolled":1400,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)","n":385,"value":19.19,"note":"95% CI 16.59 to 20.99; Figures from the ClinicalTrials.gov results section (first posted 2025-12-31), not from a publication"},{"name":"Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)","n":753,"value":20.63,"note":"95% CI 19.22 to 22.77"}],"hr":0.85,"ci":[0.73,0.99],"p":"0.0351","source":"https://clinicaltrials.gov/study/NCT03602859?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)","n":385,"value":45.37,"note":"95% CI 40.28 to 52.21; Figures from the ClinicalTrials.gov results section (first posted 2025-12-31), not from a publication"},{"name":"Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)","n":753,"value":44.39,"note":"95% CI 41.17 to 47.54"}],"source":"https://clinicaltrials.gov/study/NCT03602859?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)","n":385,"value":88,"note":"95% CI 83.7 to 91.6; Figures from the ClinicalTrials.gov results section (first posted 2025-12-31), not from a publication"},{"name":"Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)","n":753,"value":88.4,"note":"95% CI 85.5 to 90.9"}],"source":"https://clinicaltrials.gov/study/NCT03602859?tab=results"}]},"route":"/trials/nct03602859/","neighbours":{"cancer":[{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"}],"technology":[{"id":"parp-inhibitor","kind":"technology","name":"PARP inhibitors","route":"/technologies/parp-inhibitor/"}],"drug":[{"id":"dostarlimab","kind":"drug","name":"Dostarlimab","route":"/drugs/dostarlimab/"},{"id":"niraparib","kind":"drug","name":"Niraparib","route":"/drugs/niraparib/"}],"company":[{"id":"gsk","kind":"company","name":"GSK","route":"/companies/gsk/"}]}}