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
Public ClinicalTrials.gov record NCT03602859. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03602859
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,400 participants
Conditions and interventions
Interventions
- Niraparib Drug
- Dostarlimab (TSR-042) Drug
- Standard of care Drug
- Dostarlimab-Placebo Drug
- Niraparib-Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 11, 2018 (Actual)
- Primary completion
- Oct 31, 2024 (Actual)
- Completion
- Apr 30, 2029 (Estimated)
- Last update posted
- Dec 31, 2025
2018 – 2029
United States locations
- U.S. sites
- 65
- U.S. states
- 27
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Anchorage | Alaska | 99508 | — |
| GSK Investigational Site | Phoenix | Arizona | 85016 | — |
| GSK Investigational Site | Tucson | Arizona | 85711 | — |
| GSK Investigational Site | Los Angeles | California | 90027 | — |
| GSK Investigational Site | Los Angeles | California | 90048 | — |
| GSK Investigational Site | Newport Beach | California | 92663 | — |
| GSK Investigational Site | Farmington | Connecticut | 06030 | — |
| GSK Investigational Site | Hartford | Connecticut | 06102 | — |
| GSK Investigational Site | Gainesville | Florida | 32608 | — |
| GSK Investigational Site | Jacksonville | Florida | 32256 | — |
| GSK Investigational Site | Geneva | Illinois | 60555 | — |
| GSK Investigational Site | Warrenville | Illinois | 60555 | — |
| GSK Investigational Site | Zion | Illinois | 60099 | — |
| GSK Investigational Site | Covington | Louisiana | 70433 | — |
| GSK Investigational Site | New Orleans | Louisiana | 70121 | — |
| GSK Investigational Site | Shreveport | Louisiana | 71103 | — |
| GSK Investigational Site | Scarborough | Maine | 04074 | — |
| GSK Investigational Site | Baltimore | Maryland | 21201 | — |
| GSK Investigational Site | Silver Spring | Maryland | 20910 | — |
| GSK Investigational Site | Boston | Massachusetts | 02215 | — |
| GSK Investigational Site | Springfield | Massachusetts | 01199 | — |
| GSK Investigational Site | Worcester | Massachusetts | 01605 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55455 | — |
| GSK Investigational Site | Billings | Montana | 59101 | — |
| GSK Investigational Site | Neptune City | New Jersey | 07753 | — |
| GSK Investigational Site | Teaneck | New Jersey | 07666 | — |
| GSK Investigational Site | Hawthorne | New York | 10532 | — |
| GSK Investigational Site | New York | New York | 10016 | — |
| GSK Investigational Site | New York | New York | 10029 | — |
| GSK Investigational Site | New York | New York | 10065 | — |
| GSK Investigational Site | Rochester | New York | 14620-4159 | — |
| GSK Investigational Site | Stony Brook | New York | 11794 | — |
| GSK Investigational Site | Syracuse | New York | 13210 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | — |
| GSK Investigational Site | Canton | Ohio | 44710 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45219 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | — |
| GSK Investigational Site | Eugene | Oregon | 97401 | — |
| GSK Investigational Site | Portland | Oregon | 97227 | — |
| GSK Investigational Site | Paoli | Pennsylvania | 19301 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15224 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15232 | — |
| GSK Investigational Site | Willow Grove | Pennsylvania | 19001-3788 | — |
| GSK Investigational Site | Wynnewood | Pennsylvania | 19096 | — |
| GSK Investigational Site | Providence | Rhode Island | 02905 | — |
| GSK Investigational Site | Charleston | South Carolina | 29425 | — |
| GSK Investigational Site | Sioux Falls | South Dakota | 57105 | — |
| GSK Investigational Site | Knoxville | Tennessee | 37920 | — |
| GSK Investigational Site | Nashville | Tennessee | 37203 | — |
| GSK Investigational Site | Nashville | Tennessee | 37205 | — |
| GSK Investigational Site | Austin | Texas | 78731 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | San Antonio | Texas | 78240 | — |
| GSK Investigational Site | The Woodlands | Texas | 77380 | — |
| GSK Investigational Site | Tyler | Texas | 75702 | — |
| GSK Investigational Site | Ogden | Utah | 84405 | — |
| GSK Investigational Site | Charlottesville | Virginia | 22903 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
| GSK Investigational Site | Kennewick | Washington | 99336 | — |
| GSK Investigational Site | Seattle | Washington | 98104 | — |
| GSK Investigational Site | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 117 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03602859, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 31, 2025 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03602859 live on ClinicalTrials.gov.