Recruiting
Phase 2

Enfortumab Vedotin

Sponsor:

Mayo Clinic

Code:

NCT06104618

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+

Healthy Volunteers: Accepted

Interventions

Enfortumab Vedotin

Computed Tomography

Magnetic Resonance Imaging

Study Details

Brief 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.

Conditions

Metastatic Penile Squamous Cell Carcinoma

Stage III Penile Cancer AJCC v8

Stage IV Penile Cancer AJCC v8

Unresectable Penile Squamous Cell Carcinoma

Study ID

NCT06104618

Start date

Dec 21, 2023

Status verified date

Jun, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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 stages include:

  • 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
  • Any T, N3 (i.e., fixed inguinal nodal mass or any pelvic lymphadenopathy), M0 OR
  • Any T, any N, M1
  • Patients with clinical N1, M0 mPSCC at protocol entry must be ineligible for surgery because of comorbidities or clinical T4 disease, or have refused surgery
  • Patients with clinical N1 - N3, M0, and no prior systemic therapy must be:

  • Unable to receive neoadjuvant (paclitaxel + ifosfamide + cisplatin) TIP because of comorbidities or refused TIP; AND
  • Unable to receive radiotherapy with curative intent, or refused radiotherapy
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  • Prior therapy is allowed. Patients may be treatment-naïve or have had any number of prior anti-cancer treatments
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Hemoglobin ≥ 9.0 g/dL obtained ≤15 days prior to registration
  • Absolute neutrophil count (ANC) ≥ 1000/mm\^3 obtained ≤ 15 days prior to registration
  • Platelet count ≥ 100,000/mm\^3 obtained ≤ 15 days prior to registration
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN for patients with Gilbert's disease obtained ≤ 15 days prior to registration
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN obtained ≤ 15 days prior to registration
  • Glomerular filtration rate (GFR) or calculated creatinine clearance ≥ 30 ml/min as estimated using the Cockcroft-Gault formula or as measured by 24-hour urine collection obtained ≤ 15 days prior to registration
  • Provide written informed consent
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria:

  • Pure verrucous carcinoma of the penis
  • Non-squamous malignancy of the penis
  • Squamous carcinoma of the urethra
  • Preexisting sensory or motor neuropathy ≥ grade 2
  • Active central nervous system (CNS) metastases. Exception: Treated CNS metastases are allowed if all of the following are true:

  • CNS metastases are clinically stable for ≥ 6 weeks prior to registration
  • If needed, steroid dose is stable and ≤ 20 mg/day of prednisone or equivalent for ≥ 2 weeks prior to registration
  • Baseline imaging shows no evidence of new or enlarged brain metastasis
  • No leptomeningeal disease
  • History of uncontrolled diabetes mellitus ≤ 3 months prior to registration NOTE: Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8.0% or HbA1c 7.0-7.9% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained
  • Failure to recover from any of the following therapies prior to registration:

  • Major surgery
  • Radiotherapy, chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive
  • Uncontrolled intercurrent illness including, but not limited to:

  • Ongoing or active infection requiring systemic treatment
  • History of cerebral vascular event (stroke or transient ischemic attack)
  • Myocardial infarction or symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III-IV) ≤ 6 months prior to registration
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Or psychiatric illness/social situations that would limit compliance with study requirements (e.g., history of substance abuse)
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Currently receiving systemic antimicrobial treatment for viral, bacterial or fungal infection. NOTE: Routine antimicrobial prophylaxis is allowed
  • Known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or active hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid (RNA) \[qualitative\] is detected)
  • Known active keratitis or corneal ulcerations. NOTE: Superficial punctate keratitis is allowed if the disorder is being adequately treated
  • Known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate and polysorbate 20) OR subject has known hypersensitivity to biopharmaceutical produced in Chinese hamster ovary cells
  • Other active malignancy ≤ 2 years prior to registration. EXCEPTIONS: Locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, or carcinoma in situ of the breast or low risk Gleason 6 prostate cancer.
  • History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile)
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Chemotherapy-naïve patients who are potentially curable (any T, N1 - N3, M0) in the absence of any condition that precludes cisplatin-based chemotherapy, such as low GFR, peripheral neuropathy, hearing impairment, or psychosocial considerations

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Enfortumab Vedotin

Given IV

Computed Tomography

Undergo CT

Magnetic Resonance Imaging

Undergo MRI

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic Hospital in Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Cassandra N. Moore, M.D.

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Winston W. Tan, M.D.

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Lance C. Pagliaro, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-08.