Phase 1/2 Clinical Study of Niraparib in Combination with Pembrolizumab in Patients with Advanced or Metastatic Triple-Negative Breast Cancer and in Patients with Recurrent Ovarian Cancer (CTMS# 16-0046)
¿ Phase 1: To evaluate dose-limiting toxicities (DLTs) of combination treatment with niraparib and pembrolizumab during the first cycle of treatment, and to establish a recommended Phase 2 dose (RP2D) and schedule
¿ Phase 2: To estimate the clinical activity of combination treatment with niraparib and pembrolizumab in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 separately for the triple-negative breast cancer (TNBC) and ovarian cancer (OC) cohorts.
¿ Phase 1 and Phase 2: To evaluate the safety and tolerability of combination treatment with niraparib and pembrolizumab using Common Terminology Criteria for Adverse Events (CTCAE, v.4.03)
¿ Phase 2: To evaluate additional measures of clinical benefit as assessed by the Investigators, including:
¿ ORR by immune-related RECIST (irRECIST)
¿ Duration of response (DOR) by RECIST v1.1 and irRECIST;
¿ Disease control rate (DCR) by RECIST v1.1 and irRECIST;
¿ Progression-free survival (PFS) by RECIST v1.1 and by irRECIST;
¿ Overall survival (OS).
¿ Phase 1 and 2: To evaluate the pharmacokinetics (PK) of niraparib during combination treatment.