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

Trisha Wise-Draper

Status and phase: Active, not recruiting; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: Niraparib; Drug: Dostarlimab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04313504

UCCI-HN-19-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Niraparib & Dostarlimab

Experimental group

Description:

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.

Treatment:

Drug: Dostarlimab

Drug: Niraparib