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.

Exclusion Criteria:

Ongoing sensory or motor neuropathy Grade ≥2.
Active central nervous system (CNS) metastases.
Immunotherapy related myocarditis, colitis, uveitis, or pneumonitis.
Prior enrollment in an enfortumab vedotin study or prior treatment with other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
Uncontrolled tumor-related pain or impending spinal cord compression.