Study on Niraparib and Dostarlimab for Treating Recurrent or Metastatic Head and Neck Cancer

Sponsor: Trisha Wise-Draper

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04313504

This clinical trial is testing a combination of two drugs, niraparib and dostarlimab, to see how well they work in treating patients with head and neck cancer that has come back or spread to other parts of the body.

Patient Parameters

Program Overview

The aim of this study is to find out how effective the combination of two drugs, dostarlimab and niraparib, is in treating patients with head and neck cancer that has returned or spread. Researchers will look at how well the cancer responds to the treatment and how long patients live without the disease getting worse.

Description

Patients with head and neck cancer that has come back or spread will receive a combination of two drugs: dostarlimab, which is an immunotherapy drug, and niraparib, which is a type of drug called a PARP inhibitor. The study will measure how well the cancer responds to this treatment, how long patients live without the cancer getting worse, and overall survival rates.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of head and neck cancer that has returned or spread and cannot be treated with surgery or radiation.
  • Be in relatively good health with an ECOG performance status of 2 or less, meaning you are able to carry out all self-care activities but may not be able to work.
  • Be able to swallow pills.

Exclusion Criteria

  • Have tumors in the nasopharynx or salivary glands.
  • Have not fully recovered from side effects of previous cancer treatments, except for hair loss.
  • Have previously been treated with both types of drugs being studied (immunotherapy and PARP inhibitors). Having been treated with one type is allowed.
  • Have a history of allergic reactions to drugs similar to niraparib or dostarlimab.
  • Have any uncontrolled illnesses.
  • Need to take steroids in doses higher than 10mg of prednisone daily.

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