Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT03602859 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Niraparib
- DRUG Standard of care
- DRUG Dostarlimab (TSR-042)
- DRUG Dostarlimab-Placebo
- DRUG Niraparib-Placebo
Study Locations (20)
California
- GSK Investigational Site — Los Angeles
- GSK Investigational Site — Los Angeles
- GSK Investigational Site — Newport Beach
Illinois
- GSK Investigational Site — Geneva
- GSK Investigational Site — Warrenville
- GSK Investigational Site — Zion
Louisiana
- GSK Investigational Site — Covington
- GSK Investigational Site — New Orleans
- GSK Investigational Site — Shreveport
Arizona
- GSK Investigational Site — Phoenix
- GSK Investigational Site — Tucson
Connecticut
- GSK Investigational Site — Farmington
- GSK Investigational Site — Hartford
Florida
- GSK Investigational Site — Gainesville
- GSK Investigational Site — Jacksonville
Maryland
- GSK Investigational Site — Baltimore
- GSK Investigational Site — Silver Spring
Alaska
- GSK Investigational Site — Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,400 participants |
| Start Date | 2018-10-11 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03602859
The ClinicalTrials.gov registry entry for NCT03602859 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Ovarian Neoplasms appearing as the primary indexed condition, and to 5 interventions — of which Niraparib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03602859 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Illinois, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03602859 about?
NCT03602859 is a clinical study titled "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". 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 sever...
What is the current status of trial NCT03602859?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,400 participants. The study started on 2018-10-11. Estimated completion is 2029-04-30.
What conditions does trial NCT03602859 study?
This clinical trial studies the following conditions: Ovarian Neoplasms, Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03602859?
The interventions under investigation include: Niraparib (DRUG), Standard of care (DRUG), Dostarlimab (TSR-042) (DRUG), Dostarlimab-Placebo (DRUG), Niraparib-Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03602859?
This trial is sponsored by Tesaro, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03602859 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.