Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

Inclusion Criteria: * Histologically documented, unresectable locally advanced or metastatic urothelial carcinoma * Measurable disease by investigator assessment according to RECIST v1.1 * Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy * Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions: * Participants that received neoadjuvant chemotherapy with recurrence \>12 months from completion of therapy are permitted * Participants that received adjuvant chemotherapy following cystectomy with recurrence \>12 months from completion of therapy are permitted * Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment * Archival tumor tissue comprising muscle-invasive urothelial carcinoma or a biopsy of metastatic urothelial carcinoma must be provided for PD-L1 testing prior to randomization * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 * Adequate hematologic and organ function Exclusion Criteria: * Previously received enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugate (ADCs) * Received prior treatment with a programmed cell death ligand-1 (PD-(L)-1) inhibitor for any malignancy, inc…