Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC (NCT04313504) | Clinical Trial Compass
CompletedPhase 2
Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
United States10 participantsStarted 2020-11-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.