Trials / Recruiting
RecruitingNCT05526989
Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma
A Phase 2 Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma Who Have Progressed Following Chemotherapy
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy and safety of the combination of niraparib and dostarlimab in patients participants with advanced relapsed/refractory penile cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dostarlimab | 300 mg Dostarlimb will be administered by IV, increasing to 1000 mg after cycle 4. |
| DRUG | Niraparib | 200 mg Niraparib will be taken once daily by mouth days 1-21 of all cycles. |
Timeline
- Start date
- 2022-12-28
- Primary completion
- 2026-11-01
- Completion
- 2027-11-01
- First posted
- 2022-09-02
- Last updated
- 2025-12-04
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05526989. Inclusion in this directory is not an endorsement.