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)

Status: Terminated
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must be female \>=18 years of age, able to understand the study procedures, and subsequently agreed to participate in the study by providing written informed consent.

• Participants must have recurrent high-grade serous, endometrioid, or clear cell ovarian, fallopian tube, or primary peritoneal cancer.

• Participants must be considered resistant to the last administered platinum therapy.

• Participants must have completed at least 1 but no more than 3 prior lines of therapy for advanced or metastatic ovarian cancer.

• Participants must have been previously treated with platinum-based regimen, taxane agent(s), and bevacizumab.

• Participant has measurable disease according to RECIST v.1.1.

• Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Participant has adequate organ function.

• Females with childbearing potential have a serum pregnancy test that is negative 72 prior first dose and are not breastfeeding. Participant must also agree to abstain from activities that could result in pregnancy from enrollment through 180 days after the last dose of study treatment.

• Participant must provide formalin fixed paraffin embedded (FFPE) tumor tissue block(s) with sufficient tumor content (as confirmed by the Sponsor's designated central laboratory) during screening to enable BRCA testing and PD-L1 testing. The use of slides created from paraffin-embedded tissue as opposed to FFPE blocks must be approved by the Sponsor.

• Participant must agree to complete health-related quality of life (HRQoL) questionnaires throughout the study.

Locations
United States
Arizona
GSK Investigational Site
Scottsdale
California
GSK Investigational Site
Duarte
GSK Investigational Site
Newport Beach
GSK Investigational Site
Orange
GSK Investigational Site
Solvang
Florida
GSK Investigational Site
Deerfield Beach
GSK Investigational Site
Miami
GSK Investigational Site
Orlando
GSK Investigational Site
Tampa
Iowa
GSK Investigational Site
Iowa City
Massachusetts
GSK Investigational Site
Boston
GSK Investigational Site
Boston
GSK Investigational Site
Burlington
Minnesota
GSK Investigational Site
Minneapolis
Mississippi
GSK Investigational Site
Jackson
North Carolina
GSK Investigational Site
Durham
New York
GSK Investigational Site
New York
Ohio
GSK Investigational Site
Cleveland
GSK Investigational Site
Cleveland
Oregon
GSK Investigational Site
Eugene
Rhode Island
GSK Investigational Site
Providence
Tennessee
GSK Investigational Site
Chattanooga
GSK Investigational Site
Germantown
Texas
GSK Investigational Site
Austin
GSK Investigational Site
Fort Worth
GSK Investigational Site
San Antonio
Virginia
GSK Investigational Site
Charlottesville
Time Frame
Start Date: 2019-10-03
Completion Date: 2022-01-12
Participants
Target number of participants: 41
Treatments
Experimental: Niraparib+Dostarlimab (TSR-042)
Participants with body weight ≥77 kilogram (kg) and platelet count ≥150,000/microliter (μL) at baseline were administered Niraparib 300 milligram (mg) once daily (QD) and participants with body weight \<77 kg or platelet count \<150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until Progressive disease (PD) or toxicity. Dostarlimab (TSR-042) was administered as an intravenous (IV) infusion of 500 mg once every three weeks (Q3W) from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab (TSR-042) was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months.
Related Therapeutic Areas
Sponsors
Leads: Tesaro, Inc.
Collaborators: Gynecologic Oncology Group

This content was sourced from clinicaltrials.gov