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

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.

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.

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.