A Phase 2 Study of the Combination Dostarlimab with Niraparib In Patients with Penile Carcinoma Who Have Progressed Following Chemotherapy
The purpose of the study is to evaluate the efficacy and safety of the combination of niraparib and dostarlimab in patients participants with advanced relapsed/refractory penile cancer.
Primary Objective: The primary objective of this study is to evaluate the efficacy, as measured by confirmed ORR per iRECIST based on Investigator assessment, of the combination of niraparib and dostarlimab in patients with advanced penile cancer after receiving chemotherapy. Secondary Objectives: To evaluate the efficacy of dostarlimab in combination with niraparib by assessing: - overall survival (OS) - progression-free survival (PFS), using iRECIST. To evaluate the efficacy of dostarlimab in combination with niraparib by assessing the following per RECIST v.1.1: - overall response rate (ORR) - disease control rate (DCR) To evaluate the safety and tolerability of the niraparib and dostarlimab combination in patients with PSCC as measured by standard safety assessments. Tertiary/Exploratory Objective: To evaluate molecular, viral and immune markers for pathways associated with response.
Dostarlimab (); Niraparib (); TSR-042 (Dostarlimab)
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