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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Niraparib
* Drug: Dostarlimab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Niraparib & Dostarlimab<br>Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg. Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks. | Drug: Niraparib<br>* Niraparib & Dostarlimab combination<br>* Other names: ZEJULA;Drug: Dostarlimab<br>* Niraparib & Dostarlimab combination<br>* Other names: TSR-042;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response | Measured by assessing best overall response using RECIST 1.1 in subjects in recurrent and/or metastatic HNSCC patients receiving combination of niraparib and dostarlimab. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all Adverse Events | As determined by CTCAE v5.0 in subjects with recurrent and/or metastatic HNSCC receiving combination of niraparib and dostarlimab. | 30 days after completion of treatment | 
| Progression Free Survival | Measured using Kaplan Meier Curves from time of treatment start until time of progression | 1 and 3 years | 
| Overall Survival | Measured using Kaplan Meier Curves from diagnosis until time of death | 5 years |