Status:
ACTIVE_NOT_RECRUITING
Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
Lead Sponsor:
Trisha Wise-Draper
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Histologically, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous HNSCC for which there are no surgical or radiation curative options.
- ECOG performance status ≤2
- Patients must be able to swallow pills
Exclusion
- Nasopharyngeal and salivary gland tumors
- Patients who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia
- Prior exposure to both immunotherapy drugs (PD-1, PDL-1, CTLA-4 inhibitors) and PARP inhibitors. Single exposure to either immunotherapy or PARP inhibitors is allowable.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab.
- Patients with uncontrolled intercurrent illness.
- Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.
Key Trial Info
Start Date :
November 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04313504
Start Date
November 4 2020
End Date
June 1 2025
Last Update
August 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219