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

NCT06104618 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC200505NCI-2023-0862420-011329
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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

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

Outcome Measures

Primary Outcomes (1)

• Best response rate

  Defined as the proportion of patients who experience either a partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The best response rate of CR/PR will be reported descriptively and a 95% confidence interval will be reported.

  Up to 5 years

Secondary Outcomes (6)

• Objective response rate (ORR)

  Up to 5 years

• Progression free survival (PFS)

  From study entry to the first of either disease progression or death from any cause, up to 5 years

• Overall survival (OS)

  From study entry to death from any cause, up to 5 years

• Incidence of adverse events

  Up to 30 days after last dose of study medication

• Duration of Response

  Up to 5 years

Study Arms (1)

Treatment (Enfortumab vedotin)

EXPERIMENTAL

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.

Drug: Enfortumab Vedotin; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging

Interventions

Enfortumab Vedotin DRUG

Given IV

Also known as: AGS 22ME, AGS-22M6E, Anti-Nectin 4 ADC ASG-22CE, Anti-nectin-4 Monoclonal Antibody-Drug Conjugate AGS-22M6E, ASG-22CE, Enfortumab Vedotin-ejfv, Padcev

Treatment (Enfortumab vedotin)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Axial Tomorgraphy, computed axial tomogrpahy, Computerized Tomography, computerized tmography, Computerized Tomography (CT) scan, CT, CT Scan

Treatment (Enfortumab vedotin)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: MRI, Magnetic Resonance Imaging (MRI), Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging, Nuclear Resonance Magnetic Imaging, structural MRI, sMRI

Treatment (Enfortumab vedotin)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Penile Neoplasms

Interventions

enfortumab vedotin; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Lance C. Pagliaro, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: December 21, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (3)