Skip to main content
OpenTrials
Completed

NCT Number: NCT04313504

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Niraparib

Drug

Niraparib & Dostarlimab combination

Other names: ZEJULA

Dostarlimab

Drug

Niraparib & Dostarlimab combination

Other names: TSR-042

Primary outcomes

  1. Overall Response

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Progression Free Survival

    Time frame: 1 and 3 years

    Measured using Kaplan Meier Curves from time of treatment start until time of progression

  2. Overall Survival

    Time frame: Through study completion, an average of 10 months

    Measured using Kaplan Meier Curves from diagnosis until time of death

Sponsors and collaborators

Lead sponsor

Trisha Wise-Draper

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Mar 18, 2020
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.