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
Condition(s) studied
Investigational drug(s) / intervention(s)
Niraparib: Participants will receive oral capsules of niraparib as a unit dosage strength of 100 milligrams (mg)
Dostarlimab (TSR-042): Participants will receive 500 mg dostarlimab on day 1 every 3 weeks from cycle 2 to 6 followed by 1000mg of dostarlimab on day 1 every 6 weeks to continue up to 3 years in the absence of disease progression, unacceptable toxicity, participant withdrawal, or investigator decision
Standard of care: Participants will receive SOC that includes paclitaxel 175 milligrams per square meter (mg/m\^2) on day 1 every 21 days + carboplatin area under the curve (AUC) of 5 to 6 milligrams per milliliter per minute (mg/mL/min) on day 1 every 21 days +/- bevacizumab 7.5 milligrams per kilograms (mg/kg) every 21 days or 15 mg/kg every 21 days for a total of 15 months.
Dostarlimab-Placebo: Participants will receive 500 mg of dostarlimab-placebo on day 1 every 3 weeks from cycle 2 to 6 followed by 1000 mg of dostarlimab-placebo on day 1 every 6 weeks to continue up to 3 years in the absence of disease progression, unacceptable toxicity, participant withdrawal, or investigator decision
Niraparib-Placebo: Participants will receive oral capsules of niraparib-placebo as a unit dosage strength of 100 mg.
Study summary
Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare the progression-free survival (PFS) for participants receiving dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus participants receiving SOC with chemotherapy followed by niraparib maintenance. This comparison will be investigated in participants of newly diagnosed stage III or IV advanced non-mucinous epithelial ovarian cancer participants and also to compare PFS of all participants with Stage III or IV high-grade non-mucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab (TSR-042), and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — Up to approximately 316 weeks
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documented progressive disease (PD) or death due to any cause, whichever occurs first by the Investigator assessment according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeter (mm).
Trial sites (182)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Anchorage | Alaska | |
| GSK Investigational Site | Phoenix | Arizona | |
| GSK Investigational Site | Tucson | Arizona | |
| GSK Investigational Site | Los Angeles | California | |
| GSK Investigational Site | Los Angeles | California | |
| GSK Investigational Site | Newport Beach | California | |
| GSK Investigational Site | Farmington | Connecticut | |
| GSK Investigational Site | Hartford | Connecticut | |
| GSK Investigational Site | Gainesville | Florida | |
| GSK Investigational Site | Jacksonville | Florida | |
| GSK Investigational Site | Geneva | Illinois | |
| GSK Investigational Site | Warrenville | Illinois | |
| GSK Investigational Site | Zion | Illinois | |
| GSK Investigational Site | Covington | Louisiana | |
| GSK Investigational Site | New Orleans | Louisiana | |
| GSK Investigational Site | Shreveport | Louisiana | |
| GSK Investigational Site | Scarborough | Maine | |
| GSK Investigational Site | Baltimore | Maryland | |
| GSK Investigational Site | Silver Spring | Maryland | |
| GSK Investigational Site | Boston | Massachusetts | |
| GSK Investigational Site | Springfield | Massachusetts | |
| GSK Investigational Site | Worcester | Massachusetts | |
| GSK Investigational Site | Minneapolis | Minnesota | |
| GSK Investigational Site | Minneapolis | Minnesota | |
| GSK Investigational Site | Billings | Montana | |
| GSK Investigational Site | Neptune City | New Jersey | |
| GSK Investigational Site | Teaneck | New Jersey | |
| GSK Investigational Site | Hawthorne | New York | |
| GSK Investigational Site | New York | New York | |
| GSK Investigational Site | New York | New York | |
| GSK Investigational Site | New York | New York | |
| GSK Investigational Site | Rochester | New York | |
| GSK Investigational Site | Stony Brook | New York | |
| GSK Investigational Site | Syracuse | New York | |
| GSK Investigational Site | Charlotte | North Carolina | |
| GSK Investigational Site | Canton | Ohio | |
| GSK Investigational Site | Cincinnati | Ohio | |
| GSK Investigational Site | Oklahoma City | Oklahoma | |
| GSK Investigational Site | Eugene | Oregon | |
| GSK Investigational Site | Portland | Oregon |
+ 142 more sites — see the full list on the official registry below.
On this site
📄 Zejula (niraparib) drug profile →More Tesaro, Inc. trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03602859 on ClinicalTrials.gov ↗ ← All trials in the UK