Clincosm LogoSign in Get a demo

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

Sponsor
Trisha Wise-Draper (Other)
Overall Status
Recruiting
CT.gov ID
NCT04313504
Collaborator
GlaxoSmithKline (Industry)
23
Enrollment
2
Locations
1
Arm
78.9
Anticipated Duration (Months)
11.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 4, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Niraparib & Dostarlimab

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
Niraparib & Dostarlimab combination
Other Names:
  • ZEJULA

    • Drug: Dostarlimab
    Niraparib & Dostarlimab combination
    Other Names:
  • TSR-042

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response [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 Outcome Measures

    1. Rate of all Adverse Events [30 days after completion of treatment]

      As determined by CTCAE v5.0 in subjects with recurrent and/or metastatic HNSCC receiving combination of niraparib and dostarlimab.

    2. Progression Free Survival [1 and 3 years]

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

    3. Overall Survival [5 years]

      Measured using Kaplan Meier Curves from diagnosis until time of death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Cincinnati Medical Center Cincinnati Ohio United States 45219
    2 Ohio State University Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Trisha Wise-Draper
    • GlaxoSmithKline

    Investigators

    • Principal Investigator: Trisha Wise-Draper, MD, PhD, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Trisha Wise-Draper, Principal Investigator, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT04313504
    Other Study ID Numbers:
    • UCCI-HN-19-03
    First Posted:
    Mar 18, 2020
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Niraparib

    Study Results

    No Results Posted as of Sep 16, 2021