A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer

Inclusion Criteria: * Participants can give signed informed consent/assent. * Participants with histologically confirmed locally advanced or metastatic or locally advanced/unresectable urothelial carcinoma (including renal, pelvis, ureter, urinary bladder, urethra). * Able to provide, a tumor tissue sample collected during screening and prior to administration of bintrafusp alfa. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Participants with adequate organ system functions. * Life expectancy of at least 12 weeks. * A female is eligible if she is not pregnant or breastfeeding. Exclusion Criteria: * Active brain and/or leptomeningeal disease that is symptomatic or requires therapeutic intervention. Participants with asymptomatic central nervous system (CNS) metastases who are clinically stable as demonstrated by serial brain images and have no requirement for corticosteroids for at least 14 days prior to enrollment are eligible. * History of malignancy other than urothelial cancer within the last 3 years except for localized tumors that have been treated with curative intent or have not required therapy in the past 2 years. (e.g., resected non-melanoma skin cancer). * No more than 2 lines of systemic therapy for the treatment of metastastic disease. If the most recent therapy was not a platinum-based regimen, the participant must have progressed on or after that therapy. * Cirrhosis or current unstable liver or biliary disease per investigator a…