Phase 2 study of dostarlimab plus niraparib in stage III-IV recurrent or refractory Penile squamous cell carcinoma.

Management of penile squamous cell carcinoma (PSCC) remains challenging, with limited effective treatment options. Preclinical studies have shown that combining a PD-1 inhibitor with a PARP inhibitor may produce synergistic antitumor activity. This phase II trial will evaluate the combination of niraparib (PARP inhibitor) with dostarlimab (PD-1 inhibitor) in patients with recurrent or refractory stage III or IV PSCC. The primary endpoint will be the objective response rate (ORR) assessed using iRECIST. Progression-free survival (PFS), overall survival (OS), and safety will be included as secondary endpoints. A first stage cohort of 15 patients will be enrolled; if the ORR exceeds 13%, enrollment will be expanded to include an additional 10 patients in the second stage. If successful, this combination could represent a novel therapeutic strategy for advanced platinum refractory PSCC.Clinical trial registration: www.clinicaltrials.gov identifier is NCT05526989.