This phase II trial tests how well enfortumab vedotin works for treating patients with squamous cell carcinoma of the penis that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them.
Age ≥ 18 years
Histological confirmation of squamous cell carcinoma of the penis (PSCC): NOTE: Biopsy confirmation of at least one site of metastasis is encouraged but not required.
Any T, N1 (i.e., a palpable mobile unilateral inguinal lymph node), M0 OR
Any T, N2 (i.e., palpable mobile multiple or bilateral inguinal lymph nodes), M0 OR
Pure verrucous carcinoma of the penis
Non-squamous malignancy of the penis
Squamous carcinoma of the urethra
Preexisting sensory or motor neuropathy ≥ grade 2
Single group
Enfortumab Vedotin
DrugGiven IV
Computed Tomography
Procedure/SurgeryUndergo CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Best response rate
Defined as the proportion of patients who experience either a partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The best response rate of CR/PR will be reported descriptively and a 95% confidence interval will be reported.
Objective response rate (ORR)
Defined as the proportion of patients who experience either a confirmed partial response or confirmed complete response as defined by RECIST v1.1. ORR will be reported descriptively and a 95% confidence interval will be reported.
Progression free survival (PFS)
Will be estimated using the Kaplan-Meier method. The median PFS and 95% confidence interval will be reported.
Overall survival (OS)
Will be estimated using the Kaplan-Meier method. The median OS and 95% confidence interval will be reported.
Incidence of adverse events
The maximum grade for each type of adverse event by patient will be summarized by frequencies and percentages using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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