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)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: GSK Investigational Site — Anchorage, Alaska
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (182 Sites)
Showing the first 25 of 182 sites.
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ovarian Neoplasms
- A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy — Tempe, Arizona
- BMX-001 + Paclitaxel in Adult Patients With Advanced, Recurrent, Metastatic Ovarian or Endometrial Cancer — Durham, North Carolina
- Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants — New York, New York
- Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer — Little Rock, Arkansas
- A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01) — Randwick, New South Wales
Explore by condition: All Ovarian Neoplasms clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.