Mayo Clinic
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.
PRIMARY OBJECTIVE: I. To estimate the best response rate of enfortumab vedotin treatment for patients with metastatic penile squamous cell carcinoma (mPSCC). SECONDARY OBJECTIVES: I. To determine overall response rate (ORR). II. To determine safety and tolerance of enfortumab vedotin in men with mPSCC. III. To characterize duration of response to enfortumab vedotin in mPSCC. IV. To estimate median overall survival and progression-free survival in men with mPSCC treated with enfortumab vedotin. V. To analyze response in subgroups by human papillomavirus (HPV) status (related/unrelated as as…
Inclusion Criteria: * 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. * At least one site of metastatic or unresectable PSCC. NOTE: Prior therapy is not required for patients whose treatment is considered palliative (for example, presence of distant metastasis). NOTE: Patients who are potentially curable (any T, N1 - N3, M0) must have had tumor progression after standard chemotherapy, radiotherapy, or surgery, or be unable to receive such treatment. Eligible…
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