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A Phase 2 Open-Label, Single-Arm Study To Evaluate the Efficacy and Safety of the Combination OF Niraparib and TSR-042 in Patients with Platinum-Resistant Ovarian Cancer (MOONSTONE)
This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and TSR-042 in patients with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer without known BRCA mutation who have platinum-resistant disease and who have also been previously treated with bevacizumab.
Primary Objective: The primary objective of this study is to evaluate the efficacy, as measured by confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on Investigator assessment, of the combination of niraparib and TSR-042 in patients with platinum-resistant ovarian cancer (PROC) without a known germline breast cancer susceptibility gene (gBRCA) mutation who have been previously treated with bevacizumab. Secondary Objectives: To evaluate the overall clinical benefit of the niraparib and TSR-042 combination as measured by the following secondary endpoints: − duration of response (DOR) per RECIST v1.1 based on Investigator assessment − progression-free survival (PFS) per RECIST v1.1 based on Investigator assessment − overall survival (OS) − disease control rate (DCR), defined as the percentage of patients who have achieved best overall response (BOR) of confirmed partial response (PR), complete response (CR), or stable disease (SD) per RECIST v1.1 based on Investigator assessment. To evaluate the ORR per RECIST v1.1 based on independent review committee assessment, To evaluate the safety and tolerability of the niraparib and TSR-042 combination in patients with PROC as measured by standard safety assessments Exploratory Objectives: To evaluate efficacy of the niraparib and TSR-042 combination among patients with documented BRCAwt tumors (excluding patients with tBRCA mutations and unknown tBRCA status), as measured by confirmed ORR, DOR, PFS, OS, and DCR based on Investigator assessment using RECIST v1.1. To evaluate the duration of disease control among patients with BOR of CR, PR, or SD based on Investigator assessment and independent review committee assessment, To evaluate health-related quality of life (HRQoL) in patients with PROC treated with the combination of niraparib and TSR-042, as measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI). To identify additional potential disease-related or treatment-related biomarkers that correlate with responses to the niraparib and TSR-042 combination, including, but not limited to, the measures of homologous recombination repair (HRR) pathway defects