Statement: There were twice as many patients with DLT in cohort 2 of the primary trial than in cohort 1.
Primary_evidence: Outcome Measurement:    Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)   The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT:   Hematologic:   Grade 4 neutropenia lasting 8 days;   Febrile neutropenia Grade 3 or Grade 4; or   Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding   Non-hematologic:   Grade 4 toxicity;   Grade 3 symptomatic hepatic toxicities lasting >48 hours, or Grade 3 asymptomatic hepatic toxicities lasting 7 days; or   Grade 3 non-hematologic, non-hepatic organ toxicity, with exceptions   Other:   Any treatment delays for 14 days due to unresolved toxicity;   Grade 5 treatment-related adverse event (AE);   A dose reduction of study treatment during the DLT evaluation period.   Time frame: Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days. Results 1:    Arm/Group Title: Cohort A: KNp / KAC   Arm/Group Description: Participants received pembrolizumab (K) 200 mg on Cycle 1 Day 1 followed by pembrolizumab 200 mg in Cycles 2-5 on Day 1 (once every 3 weeks; Q3W) PLUS nab-paclitaxel (KNp) starting at 125 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (once each week; QW). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via intravenous (IV) infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.   Overall Number of Participants Analyzed: 10   Measure Type: Count of Participants   Unit of Measure: Participants  2  20.0% Results 2:    Arm/Group Title: Cohort B: KNpCb (Regimen 1) / KAC   Arm/Group Description: Participants first received KNpCb Regimen 1 which consisted of: pembrolizumab (K) 200 mg on Cycle 1 Day 1 PLUS nab-paclitaxel (KNp) starting at 100 mg/m^2 in Cycles 2-5 on Days 1, 8 and 15 (QW) PLUS carboplatin (Cb) starting at Area Under the Curve (AUC) 6 in Cycles 2-5 on Day 1 (Q3W). This was followed by pembrolizumab (K) 200 mg in Cycles 6-9 on Day 1 (Q3W) PLUS doxorubicin (A) 60 mg/m^2 in Cycles 6-9 on Day 1 (Q3W) PLUS cyclophosphamide (C) 600 mg/m^2 in Cycles 6-9 on Day 1 (Q3W). All treatments were administered via IV infusion except for doxorubicin (A), which was administered via IV injection. Each cycle was 21 days.   Overall Number of Participants Analyzed: 10   Measure Type: Count of Participants   Unit of Measure: Participants  4  40.0%