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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06104618
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Penile Squamous Cell Carcinoma
  • Stage III Penile Cancer AJCC v8
  • Stage IV Penile Cancer AJCC v8
  • Unresectable Penile Squamous Cell Carcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Enfortumab Vedotin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

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.

Key Dates

Start date
Dec 21, 2023
Status verified
Jun 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Enfortumab vedotin)
    Patients receive enfortumab vedotin IV over 30 minutes on days 1,8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the study.

Primary Outcome Measure

Best response rate [ Time Frame: Up to 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054
Clinical Trials Referral Office
[email protected]
855-776-0015
Cassandra N. Moore, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Winston W. Tan, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Lance C. Pagliaro, M.D. (PRINCIPAL_INVESTIGATOR)

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