Statement: the primary trial indicates that varying Pembrolizumab dosage has no effect on the Number of Subjects Reporting Dose-Limiting Toxicities (DLTs).
Primary_evidence: Outcome Measurement:    Phase 1: Number of Subjects Reporting Dose-Limiting Toxicities (DLTs)   DLTs are defined as: Any treatment-related Grade  3 non-hematologic clinical (non-laboratory) AE Any treatment-related Grade 3 or Grade 4 non-hematologic lab abnormality if: - Medical intervention is required to treat the patient, or - The abnormality leads to hospitalization, or - The abnormality persists for  7 days. Any treatment-related hematologic toxicity specifically defined as: - Thrombocytopenia Grade 4 for  7 days, or Grade 3 or 4 associated with bleeding or requiring platelet transfusion; - Neutropenia Grade 4 for  7 days, or Grade 3 or 4 associated with infection or febrile neutropenia; - Anemia Grade 4, or Grade 3 or 4 requiring blood transfusion. Any treatment-related AE leading to niraparib dose interruption per the following criteria: - A dose interruption for a non-DLT lab abnormality lasting  14 days. - A dose in interruption per dose modification rules for nonhematologic AE leading to < 80% of an intended dose being administered.   Time frame: During Cycle 1, ie, during the first 21 days of treatment Results 1:    Arm/Group Title: Phase 1: Niraparib 200mg + Pembrolizumab   Arm/Group Description: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.   Overall Number of Participants Analyzed: 6   Measure Type: Count of Participants   Unit of Measure: Participants  1  16.7% Results 2:    Arm/Group Title: Phase 1: Niraparib 300mg + Pembrolizumab   Arm/Group Description: Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.   Overall Number of Participants Analyzed: 6   Measure Type: Count of Participants   Unit of Measure: Participants  1  16.7%