Primary Outcome Measures
Part A/B/C: Dose Limiting Toxicities (DLT) [Time Frame: From date of initial dose until up to 28 days for IPI-549] [Designated as safety issue: ]
Part D/E: Adverse Events (AE) and safety laboratory values [Time Frame: Number of patients with Clinically significant abnormal laboratory values and adverse events that are related to treatment from date of initial dose until 30 days after last dose of IPI-549 and 100 days after the last dose of Nivolumab] [Designated as safety issue: ]
Secondary Outcome Measures
Part A/B: Adverse Events (AE) and safety laboratory values [Time Frame: Number of patients with Clinically significant abnormal laboratory values and adverse events that are related to treatment assessed during every visit for duration of study participation which is estimated to be 24 months] [Designated as safety issue: ]
Part A/B: Plasma concentrations of IPI-549 (metabolites, as appropriate) [Time Frame: Assessed during Days 1- 22 of Cycles 1 and 2, Assessed During Day 1 of Cycles 3 and 4] [Designated as safety issue: ]
Part A/B: Overall response rate (ORR), complete response/remission (CR) or partial response/remission (PR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part A/B: Duration of response (DoR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part C: Adverse Events (AE) and safety laboratory values [Time Frame: Number of patients with Clinically significant abnormal laboratory values and adverse events that are related to treatment assessed during every visit for duration of study participation which is estimated to be 24 months] [Designated as safety issue: ]
Part C: Plasma concentrations of IPI-549 (metabolites as appropriate) [Time Frame: Assessed during Days 1- 2 of Cycles 1 and 2] [Designated as safety issue: ]
Part C: Overall Response Rate (ORR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part C: Duration of Response (DoR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part D: Overall Response Rate (ORR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part D: Duration of Response (DoR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part D: Progression-Free Survival (PFS) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part D: Overall Survival (OS) [Time Frame: Estimated to be 3 years] [Designated as safety issue: ]
Part D: Plasma concentrations of IPI-549 (and metabolites, as appropriate) [Time Frame: Assessed during Days 1- 15 of Cycles 1 and 2, Assessed During Day 1 of Cycles 3 and 4] [Designated as safety issue: ]
Part E:Overall Response Rate (ORR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part F:Overall Response Rate (ORR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part G:Overall Response Rate (ORR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part E: Duration of Response (DoR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part F: Duration of Response (DoR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part G: Duration of Response (DoR) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part E: Progression Free Survival (PFS) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part F: Progression Free Survival (PFS) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part G: Progression Free Survival (PFS) [Time Frame: Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year] [Designated as safety issue: ]
Part E: Overall Survival (OS) [Time Frame: Estimated to be 3 years] [Designated as safety issue: ]
Part F: Overall Survival (OS) [Time Frame: Estimated to be 3 years] [Designated as safety issue: ]
Part G: Overall Survival (OS) [Time Frame: Estimated to be 3 years] [Designated as safety issue: ]
Part E: Plasma concentrations of IPI-549 (and metabolites, as appropriate) [Time Frame: Assessed during Days 1- 2 of Cycles 1 and 2] [Designated as safety issue: ]
Part F: Plasma concentrations of IPI-549 (and metabolites, as appropriate) [Time Frame: Assessed during Days 1- 2 of Cycles 1 and 2] [Designated as safety issue: ]
Part G: Plasma concentrations of IPI-549 (and metabolites, as appropriate) [Time Frame: Assessed during Days 1- 2 of Cycles 1 and 2] [Designated as safety issue: ]