Phase 2
Completed N=10
Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
Source: ClinicalTrials.gov NCT04313504 ↗Enrolled (actual)
10
Serious AEs
60.0%
Results posted
May 2026
Primary outcomePrimary: Overall Response — 0; 1; 1; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response |
0; 1; 1; 8 | — |
| SECONDARY Progression Free Survival |
3.8 | — |
| SECONDARY Overall Survival |
10.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04313504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.