RecruitingPhase 2NCT06104618

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

Phase II Study of Enfortumab Vedotin Treatment for Metastatic Squamous Cell Carcinoma of the Penis


Sponsor

Mayo Clinic

Enrollment

28 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing enfortumab vedotin — a targeted drug already approved for bladder cancer — in people with metastatic or inoperable squamous cell carcinoma of the penis (a rare cancer). It is looking at whether this drug can work for this cancer type. **You may be eligible if...** - You are 18 or older with confirmed squamous cell carcinoma of the penis that has spread or cannot be surgically removed - You are either treatment-naïve or have had prior treatments - Patients with potentially curable disease must have progressed after, or be unable to receive, standard surgery, chemotherapy, or radiation - Your general health is good (ECOG 0 or 1) - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal cord and is causing symptoms - You have had prior neuropathy (nerve damage) grade 2 or worse - You have uncontrolled diabetes that is causing complications (diabetic ketoacidosis) - You have active or uncontrolled hepatitis B or C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnfortumab Vedotin

Given IV

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI


Locations(3)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT06104618


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