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Brief Title: Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer
Official Title: A Phase 2 Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Patients With Platinum-Resistant Ovarian Cancer (MOONSTONE)
Study ID: NCT03955471
Brief Summary: This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and dostarlimab (TSR-042) in participants with advanced, relapsed, high-grade ovarian, fallopian tube, endometrioid, clear cell ovarian or primary peritoneal cancer without known breast cancer susceptibility gene (BRCA) mutation who have platinum-resistant disease and who have also been previously treated with bevacizumab.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
GSK Investigational Site, Scottsdale, Arizona, United States
GSK Investigational Site, Duarte, California, United States
GSK Investigational Site, Newport Beach, California, United States
GSK Investigational Site, Orange, California, United States
GSK Investigational Site, Solvang, California, United States
GSK Investigational Site, Deerfield Beach, Florida, United States
GSK Investigational Site, Miami, Florida, United States
GSK Investigational Site, Orlando, Florida, United States
GSK Investigational Site, Tampa, Florida, United States
GSK Investigational Site, Iowa City, Iowa, United States
GSK Investigational Site, Boston, Massachusetts, United States
GSK Investigational Site, Boston, Massachusetts, United States
GSK Investigational Site, Burlington, Massachusetts, United States
GSK Investigational Site, Minneapolis, Minnesota, United States
GSK Investigational Site, Jackson, Mississippi, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Durham, North Carolina, United States
GSK Investigational Site, Cleveland, Ohio, United States
GSK Investigational Site, Cleveland, Ohio, United States
GSK Investigational Site, Eugene, Oregon, United States
GSK Investigational Site, Providence, Rhode Island, United States
GSK Investigational Site, Chattanooga, Tennessee, United States
GSK Investigational Site, Germantown, Tennessee, United States
GSK Investigational Site, Austin, Texas, United States
GSK Investigational Site, Fort Worth, Texas, United States
GSK Investigational Site, San Antonio, Texas, United States
GSK Investigational Site, Charlottesville, Virginia, United States
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR