A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients with Urothelial Carcinoma Morpheus-UC

Prior treatment

• For mUC cohort: Stage 1 Prior treatment with a T-cell co-stimulating therapy or an immune checkpoint inhibitor, or investigational therapy within 28 days before C1D1, or any approved anti-cancer therapy within 3 weeks before study
• For mUC cohort: Stage 1 and Stage 2 Prior systemic immunostimulatory treatments within 4 weeks or 5 half-lives of the drug before study, or with systemic immunosuppressants within 2 weeks before study, or need such during study
• For MIBC Cohorts Received a live, attenuated vaccine within 4 weeks before study, or needing such during atezolizumab treatment or within 5 months after the last dose

Other illness

• For mUC cohort: Stage 1 and Stage 2 History of leptomeningeal disease, autoimmune disease, idiopathic pulmonary fibrosis (IPF), organizing pneumonia drug-induced pneumonitis, or idiopathic pneumonitis, or active pneumonitis at screening
• For mUC cohort: Stage 1 and Stage 2 Active tuberculosis (TB)
• For MIBC Cohorts Active or history of autoimmune disease or immune deficiency

• Stage 1: Availability of a representative tumor specimen that is suitable for determination of Programmed death-ligand 1 (PD-L1) and/or additional biomarker status by means of central testing
• Stage 1: Disease progression during or following treatment with no more than one platinum containing regimen for inoperable, locally advanced or metastatic UC or disease recurrence
• Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST) v1.1
• Stage 1 and Stage 2 Negative HIV test at screening
• For the Muscle Invasive Bladder Cancer Cohorts (MIBC) Availability of a TURBT specimen that is suitable for determination of PD-L1 and additional biomarker status by means of central testing
• For the Muscle Invasive Bladder Cancer Cohorts (MIBC) N0 or M0 disease assessed by CT or magnetic resonance imaging (MRI) scan (within 4 weeks of study treatment initiation)