Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Pure verrucous carcinoma of the penis

Non-squamous malignancy of the penis

Squamous carcinoma of the urethra

Preexisting sensory or motor neuropathy ≥ grade 2

Trial design

Treatments tested in this trial

  • Enfortumab Vedotin
  • Computed Tomography
  • Magnetic Resonance Imaging

Treatment groups

28 Participants
are divided into 1 treatment group

Sponsors and collaborators