Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Tesaro, Inc.
- Study ID
- NCT05751629
- Phase
- PHASE2
- Status
- Completed
Conditions
- Ovarian Neoplasm
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dostarlimab — DRUGDostarlimab was administered.
- Bevacizumab — DRUGBevacizumab was administered.
- Niraparib — DRUGNiraparib was administered.
Study Details
The primary objective of this sub study is to evaluate the efficacy of the combination of TSR-042, bevacizumab, and niraparib in participants with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 2 prior lines of anticancer therapy, are PARP inhibitor naïve, and have platinum-resistant but not refractory disease. This study is a sub study of the master protocol - OPAL (NCT03574779).
Key Dates
- Start date
- Nov 15, 2018
- Status verified
- Feb 2023
- Primary completion
- Apr 1, 2022
- Completion
- Apr 1, 2022
Study Design
- Enrollment
- 41 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort A (Dostarlimab + Bevacizumab + Niraparib)
Primary Outcome Measure
Confirmed Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment [ Time Frame: Up to approximately 38 Months ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35249 | - |
| GSK Investigational Site | Los Angeles | California | 90095 | - |
| GSK Investigational Site | Palo Alto | California | 94304 | - |
| GSK Investigational Site | Ventura | California | 93003 | - |
| GSK Investigational Site | Chicago | Illinois | 60637 | - |
| GSK Investigational Site | Boston | Massachusetts | 02114 | - |
| GSK Investigational Site | Boston | Massachusetts | 02215 | - |
| GSK Investigational Site | Rochester | Minnesota | 55905 | - |
| GSK Investigational Site | Durham | North Carolina | 27710 | - |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | - |
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