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Metastatic Penile Squamous Cell CarcinomaPhase 2NCT06104618

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

A Phase 2 study testing Enfortumab Vedotin, Computed Tomography and Magnetic Resonance Imaging in people with Metastatic Penile Squamous Cell Carcinoma and Stage III Penile Cancer AJCC v8, run by Mayo Clinic at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
What is being tested?
Enfortumab Vedotin, Computed Tomography and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesUnited States
Study dates
21 Dec 2023to 1 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States3 sites, 3 recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Winston W. Tan, M.D.

    Recruiting

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Cassandra N. Moore, M.D.

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Lance C. Pagliaro, M.D.

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To estimate the best response rate of enfortumab vedotin treatment for patients with metastatic penile squamous cell carcinoma (mPSCC).

SECONDARY OBJECTIVES:

  1. To determine overall response rate (ORR). II. To determine safety and tolerance of enfortumab vedotin in men with mPSCC. III. To characterize duration of response to enfortumab vedotin in mPSCC. IV. To estimate median overall survival and progression-free survival in men with mPSCC treated with enfortumab vedotin.
  2. To analyze response in subgroups by human papillomavirus (HPV) status (related/unrelated as assessed by p16 biomarker).

OUTLINE:

Patients receive enfortumab vedotin intravenously (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 computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.

After completion of study treatment, patients are followed up at 30 days and then every 3 months until progressive disease, followed by every 6 months for up to 5 years from registration.

Being tested
Enfortumab Vedotin, Computed Tomography, Magnetic Resonance Imaging
Medical subject headings
Penile Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enfortumab VedotinDrug

    Also called AGS 22ME, AGS-22M6E, Anti-Nectin 4 ADC ASG-22CE, Anti-nectin-4 Monoclonal Antibody-Drug Conjugate AGS-22M6E

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called MRI, Magnetic Resonance Imaging (MRI), Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR

    Undergo MRI

Study groups in NCT06104618
Study groupRoleWhat they receive
Treatment (Enfortumab vedotin)ExperimentalPatients 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.
Receives: Drug: Enfortumab Vedotin; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (6)

  1. Objective response rate (ORR)

    Defined as the proportion of patients who experience either a confirmed partial response or confirmed complete response as defined by RECIST v1.1. ORR will be reported descriptively and a 95% confidence interval will be reported.

    Measured: Up to 5 years

  2. Progression free survival (PFS)

    Will be estimated using the Kaplan-Meier method. The median PFS and 95% confidence interval will be reported.

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

  3. Overall survival (OS)

    Will be estimated using the Kaplan-Meier method. The median OS and 95% confidence interval will be reported.

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

  4. Incidence of adverse events

    The maximum grade for each type of adverse event by patient will be summarized by frequencies and percentages using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to 30 days after last dose of study medication

  5. Duration of Response

    Defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.

    Measured: Up to 5 years

  6. Best response by human papillomavirus (HPV) status

    The p16 biomarker will be used to assess HPV status. The p16 immunohistochemistry (IHC) outcome will be classified as positive, negative, or not available. Best response rates of either a CR or PR will be determined for each subgroup and 95% confidence intervals will be reported.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2023
  2. Study start21 Dec 2023
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06104618
Sponsor's protocol ID
MC200505
Other IDs
20-011329
Status last verified
Jun 2026
First submitted
23 Oct 2023
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enfortumab Vedotin, Computed Tomography and Magnetic Resonance Imaging in people with Metastatic Penile Squamous Cell Carcinoma and Stage III Penile Cancer AJCC v8, run by Mayo Clinic at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best response rate (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06104618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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