Primary Outcome Measures
(Phase 1b/Part A) Incidence of dose-limiting toxicities (DLTs) [Time Frame: Cycle 1 (up to 21 days)] [Designated as safety issue: ]
(Phase 2) Efficacy of the combination in terms of the objective response rate (ORR) [Time Frame: Duration is approximately 2 years] [Designated as safety issue: ]
Secondary Outcome Measures
(Phase 1b/Part A) Preliminary antitumor activity of the combination in terms of objective response rate (ORR) [Time Frame: Phase 1b is expected to last until disease progression] [Designated as safety issue: ]
(Phase 1b/Part A, Phase 2) Duration of response (DOR) [Time Frame: Phase 1b is expected to last until disease progression; Duration of Phase 2 is approximately 2 years] [Designated as safety issue: ]
(Phase 1b/Part A, Phase 2) Progression-free survival (PFS) [Time Frame: Phase 1b is expected to last until disease progression; Duration of Phase 2 is approximately 2 years] [Designated as safety issue: ]
(Phase 1b/Part A, Phase 2) Overall survival (OS) [Time Frame: Duration of Phase 1b is approximately 1 year; Duration of Phase 2 is approximately 2 years] [Designated as safety issue: ]
(Phase 1b/Part A, Phase 2) Immune-related response criteria (irRR) [Time Frame: Phase 1b is expected to last until disease progression; Duration of Phase 2 is approximately 2 years] [Designated as safety issue: ]
(Phase 1b/Part A, Phase 2) Immune-related progression-free survival (irPFS) [Time Frame: Phase 1b is expected to last until disease progression; Duration of Phase 2 is approximately 2 years] [Designated as safety issue: ]
(Phase 1b/Part A, Phase 2) Evaluation of the plasma concentration-time profiles of ARRY-382 and its metabolites in the combination [Time Frame: Phase 1b: Patient safety will be evaluated throughout the treatment period, which is expected to last 6-10 months for each patient; Duration of Phase 2 is approximately 2 years] [Designated as safety issue: ]
(Phase 1b/Part A, Phase 2) Safety and tolerability of the combination in terms of adverse events and serious adverse events [Time Frame: Phase 1b: Patient safety will be evaluated throughout the treatment period, which is expected to last 6-10 months for each patient; Duration of Phase 2 is approximately 2 years] [Designated as safety issue: ]
(Phase 1b/Part A, Phase 2) Trough concentrations and pharmacokinetics (AUC, Cmax, Tmax, accumulation ratio and metabolite-to-parent ratio) for ARRY-382 and its three metabolites [Time Frame: 6 months] [Designated as safety issue: ]