NCT04313504CompletedPhase 2
Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
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
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 16 Mar 2020
- Start date
- 4 Nov 2020
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Trisha Wise-Draper
- Diseases
- Head and neck cancer
- NCT number
- NCT04313504
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 10
- From 4 Nov 2020 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab.
- Patients with uncontrolled intercurrent illness.
Other
- Nasopharyngeal and salivary gland tumors
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.