Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- University of Oklahoma
- Study ID
- NCT04068753
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Progressive Cervix Cancer
- Recurrent Cervix Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Niraparib — DRUGNiraparib: 200 mg, oral, once daily, days 1-21
- dostarlimab — DRUGdostarlimab: 500 mg IV, every three weeks for 4 cycles followed by 1000 mg every six weeks for up to two years
Study Details
The purpose of this research study is to test the safety of Niraparib and dostarlimab as a combination treatment and see what effects (good and bad) this combination treatment has on patients with recurrent or progressive cervix cancer.
Key Dates
- Start date
- Feb 26, 2020
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2026
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 66 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Niraparib + dostarlimab
Primary Outcome Measure
Proportion of patients with response to treatment [ Time Frame: 1 year ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | - |
| Louisiana State University Health Science Center | New Orleans | Louisiana | 70112 | - |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | - |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22903 | - |