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

NCT04313504 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: UCCI-HN-19-03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response

  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.

  8 weeks

Secondary Outcomes (2)

• Progression Free Survival

  1 and 3 years

• Overall Survival

  Through study completion, an average of 10 months

Study Arms (1)

Niraparib & Dostarlimab

EXPERIMENTAL

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; Drug: Dostarlimab

Interventions

Niraparib DRUG

Niraparib \& Dostarlimab combination

Also known as: ZEJULA

Niraparib & Dostarlimab

Dostarlimab DRUG

Niraparib \& Dostarlimab combination

Also known as: TSR-042

Niraparib & Dostarlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trisha Wise-Draper: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

niraparib; dostarlimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Trisha Wise-Draper M.D., Ph.D.
• Organization: University of Cincinnati

wiseth@ucmail.uc.edu

(513) 558-2826

Study Officials

• Trisha Wise-Draper, MD, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: November 4, 2020
• Primary Completion: June 1, 2025
• Study Completion: March 4, 2026
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)