A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Inclusion Criteria

• •Histologically documented urothelial carcinoma (squamous differentiation or mixed cell types allowed).
• •Metastatic disease or locally advanced disease that is not resectable.
• •Must have received prior treatment with a CPI in the locally advanced or metastatic urothelial cancer setting. A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Patients who received CPI therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or within 3 months of therapy completion are eligible.
• •Must either have prior treatment with platinum-containing chemotherapy (Cohort 1) or be platinum-naïve and ineligible for treatment with cisplatin at time of enrollment (Cohort 2).
• •Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
• •Tumor tissue samples must be available for submission to the sponsor prior to study treatment.
• •Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).
• •An Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1 for Cohort 1 or ≤2 for Cohort 2.
• •Anticipated life expectancy of ≥3 months as assessed by the investigator.