NCT04068753

Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer

Phase II Trial of Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer (OU-SCC-STAR)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive treatment with Niraparib daily and dostarlimab by vein every three weeks for 4 cycles then every six weeks. Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects. Patients will be monitored during treatment with tests and exams and after treatment completion for up to 5 years.

Conditions

• Recurrent Cervix Cancer
• Progressive Cervix Cancer

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib: 200 mg, oral, once daily, days 1-21
DRUG	dostarlimab	dostarlimab: 500 mg IV, every three weeks for 4 cycles followed by 1000 mg every six weeks for up to two years

Timeline

• Start date: 2020-02-26
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2019-08-28
• Last updated: 2026-02-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study