Primary Outcomes:

Primary Outcome 1 - Measure: Objective response rate (ORR) by an independent review facility (IRF)

Primary Outcome 1 - Time Frame: Up to 3 years

Condition:

• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urologic Neoplasms
• Renal Pelvis Neoplasms
• Urothelial Cancer
• Ureteral Neoplasms
• Urethral Neoplasms

Eligibility

Criteria:
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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No