Clinical trial · Interventional
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
NCT04313504CI-TRIAL-00110803completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dostarlimab | Drug | Dostarlimab | ALIAS |
| Niraparib | Drug | Niraparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Niraparib & Dostarlimab
- description
- 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.
- interventionNames
- Drug: Niraparib
- Drug: Dostarlimab
Primary outcomes (1)
- measure
- Overall Response
- timeFrame
- 8 weeks
- description
- 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 outcomes (2)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.