Clinical Trials /

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

NCT04313504

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04313504

Trial Eligibility

Document

Title

  • Brief Title: Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: UCCI-HN-19-03
  • NCT ID: NCT04313504

Conditions

  • Head and Neck Cancer

Interventions

DrugSynonymsArms
NiraparibZEJULANiraparib & Dostarlimab
DostarlimabTSR-042Niraparib & Dostarlimab

Purpose

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

      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.

Trial Arms

NameTypeDescriptionInterventions
Niraparib & DostarlimabExperimentalNiraparib 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.
  • Niraparib
  • Dostarlimab

Eligibility Criteria

        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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response
Time Frame:8 weeks
Safety Issue:
Description: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 Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Trisha Wise-Draper

Last Updated

November 12, 2020