Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

• Status: Recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trisha Wise-Draper
• Collaborators: GlaxoSmithKline; Tesaro, Inc.
• Treatments: Niraparib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.