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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Trisha Wise-Draper
Study ID
NCT04313504
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib \& Dostarlimab combination
  • Dostarlimab — DRUG
    Niraparib \& Dostarlimab combination

Study Details

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.

Key Dates

Start date
Nov 4, 2020
Status verified
May 2026
Primary completion
Jun 1, 2025
Completion
Mar 4, 2026

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall Response [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati Medical CenterCincinnatiOhio45219-

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