Trials / Active Not Recruiting
Active Not RecruitingNCT04313504
Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
An Open-label, Phase II Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- Sponsor
- Trisha Wise-Draper · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.
Detailed description
Recurrent and/or metastatic HNSCC patients will be treated with combination of the PD-1 inhibitor (dostarlimab) and PARPi (niraparib) concurrently and ORR, PFS and OS will be determined.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib | Niraparib \& Dostarlimab combination |
| DRUG | Dostarlimab | Niraparib \& Dostarlimab combination |
Timeline
- Start date
- 2020-11-04
- Primary completion
- 2024-06-01
- Completion
- 2025-06-01
- First posted
- 2020-03-18
- Last updated
- 2024-08-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04313504. Inclusion in this directory is not an endorsement.