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

Completed · Phase 2

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT04313504

Run by

Trisha Wise-Draper

People needed

10

Starts

2020-11-04

Expected to finish

2026-03-04

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Cincinnati Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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