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ACTIVE NOT RECRUITING
NCT03602859
PHASE3

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

Sponsor: Tesaro, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1400

Start Date

2018-10-11

Completion Date

2029-04-30

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DRUG

Niraparib

Participants will receive oral capsules of niraparib as a unit dosage strength of 100 milligrams (mg)

DRUG

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

DRUG

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.

DRUG

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

DRUG

Niraparib-Placebo

Participants will receive oral capsules of niraparib-placebo as a unit dosage strength of 100 mg.

Locations (182)

GSK Investigational Site

Anchorage, Alaska, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Farmington, Connecticut, United States

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Hartford, Connecticut, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Geneva, Illinois, United States

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Warrenville, Illinois, United States

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Zion, Illinois, United States

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Covington, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Silver Spring, Maryland, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Worcester, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Billings, Montana, United States

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Neptune City, New Jersey, United States

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Teaneck, New Jersey, United States

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Hawthorne, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Stony Brook, New York, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Paoli, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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The Woodlands, Texas, United States

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Tyler, Texas, United States

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Ogden, Utah, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Kennewick, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Minsk, Belarus

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Brasschaat, Belgium

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Bruges, Belgium

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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Windsor, Canada

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Prague, Czechia

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Prague, Czechia

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Copenhagen, Denmark

GSK Investigational Site

Herlev, Denmark

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Roskilde, Denmark

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Helsinki, Finland

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Kuopio, Finland

GSK Investigational Site

Tampere, Finland

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Turku, Finland

GSK Investigational Site

Angers, France

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Avignon, France

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Besançon, France

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Bordeaux, France

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Bron, France

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Caen, France

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Cholet, France

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Clermont-Ferrand, France

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Dijon, France

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Grenoble, France

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Grenoble, France

GSK Investigational Site

Le Mans, France

GSK Investigational Site

Lille, France

GSK Investigational Site

Lyon, France

GSK Investigational Site

Lyon, France

GSK Investigational Site

Lyon, France

And 82 more locations on ClinicalTrials.gov