Actively Recruiting
Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis
Led by Mayo Clinic · Updated on 2025-12-11
28
Participants Needed
3
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological confirmation of squamous cell carcinoma of the penis
- At least one site of metastatic or unresectable penile squamous cell carcinoma
- Patients with certain stages (N1 to N3, M0) must have tumor progression after standard treatments or be unable to receive them
- Patients with clinical N1, M0 must be ineligible for surgery due to other health issues or have refused surgery
- Patients with clinical N1 to N3, M0 without prior systemic therapy must be unable or have refused certain chemotherapy and radiotherapy treatments
- Measurable disease by RECIST 1.1 criteria
- Patients can be treatment-na�ve or have received prior therapies
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Hemoglobin level at least 9.0 g/dL within 15 days before registration
- Absolute neutrophil count at least 1000/mm3 within 15 days before registration
- Platelet count at least 100,000/mm3 within 15 days before registration
- Total bilirubin less than or equal to 1.5 times normal limit or up to 3 times for Gilbert's disease within 15 days before registration
- ALT and AST levels less than or equal to 2.5 times normal limit within 15 days before registration
- Glomerular filtration rate or creatinine clearance at least 30 ml/min within 15 days before registration
- Provide written informed consent
- Willingness to return to the enrolling institution for follow-up
You will not qualify if you...
- Pure verrucous carcinoma of the penis
- Non-squamous malignancy of the penis
- Squamous carcinoma of the urethra
- Preexisting sensory or motor neuropathy grade 2 or higher
- Active central nervous system metastases unless stable and well controlled
- History of uncontrolled diabetes mellitus within 3 months
- Not recovered from recent major surgery, radiotherapy, chemotherapy, biologics, investigational agents, or immunotherapy
- Immunocompromised or HIV positive
- Uncontrolled illness including active infection, recent stroke, recent heart attack or severe heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness limiting compliance
- Receiving other investigational agents for primary cancer
- Currently on systemic antimicrobial treatment for infection (routine prophylaxis allowed)
- Known active hepatitis B or C infection
- Known active keratitis or corneal ulcerations (superficial keratitis allowed if treated)
- Known allergy to enfortumab vedotin or its components
- Other active cancers within 2 years except certain locally curable cancers
- Recent myocardial infarction or congestive heart failure requiring ongoing treatment for life-threatening arrhythmias
- Sexually active patients unwilling to use effective contraception unless surgically sterile
- Severe co-morbid systemic illnesses or diseases affecting safety assessment
- Chemotherapy-na�ve patients potentially curable by standard treatments without contraindications to cisplatin-based chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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