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A Phase 2, Multicenter, Randomized, Single-Blind, Active-Control Study to Evaluate the Efficacy and Safety of Nivolumab Administered in Combination with IPI-549 Compared to Nivolumab Monotherapy in the Treatment of Patients with Immune Therapy-Naïve, Advanced Urothelial Carcinoma

Primary Objective: To compare the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with baseline mMDSC levels greater than or equal to 22.3 percent following combination treatment with nivolumab plus IPI-549 with that of nivolumab monotherapy. Secondary Objectives: To compare ORR per RECIST v1.1 in patients with baseline mMDSC levels less than 22.3 percent and in all patients regardless of baseline mMDSC level following combination treatment with nivolumab plus IPI-549 with that of nivolumab monotherapy. To evaluate time to response (TTR), duration of response (DOR), and progression-free survival (PFS) following combination treatment with nivolumab plus IPI-549 relative to nivolumab monotherapy. To evaluate the safety of combination treatment with nivolumab plus IPI-549. To evaluate the pharmacokinetics (PK) of IPI-549 administered in combination with nivolumab. Exploratory Objectives: To evaluate ORR by immune RECIST (iRECIST) following combination treatment with nivolumab plus IPI-549. To evaluate overall survival (OS) of patients receiving combination treatment with nivolumab plus IPI-549.

Primary Objective: To compare the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with baseline mMDSC levels greater than or equal to 22.3 percent following combination treatment with nivolumab plus IPI-549 with that of nivolumab monotherapy. Secondary Objectives: To compare ORR per RECIST v1.1 in patients with baseline mMDSC levels less than 22.3 percent and in all patients regardless of baseline mMDSC level following combination treatment with nivolumab plus IPI-549 with that of nivolumab monotherapy. To evaluate time to response (TTR), duration of response (DOR), and progression-free survival (PFS) following combination treatment with nivolumab plus IPI-549 relative to nivolumab monotherapy. To evaluate the safety of combination treatment with nivolumab plus IPI-549. To evaluate the pharmacokinetics (PK) of IPI-549 administered in combination with nivolumab. Exploratory Objectives: To evaluate ORR by immune RECIST (iRECIST) following combination treatment with nivolumab plus IPI-549. To evaluate overall survival (OS) of patients receiving combination treatment with nivolumab plus IPI-549.