A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma

May 26, 2026 updated by: Memorial Sloan Kettering Cancer Center

Interrogating Enfortumab Vedotin-associated Neuropathy in Patients With Metastatic or Muscle-Invasive Urothelial Carcinoma Receiving Enfortumab Vedotin

The purpose of this study is to see how results of nerve tests change in people with urothelial cancer who receive treatment with enfortumab vedotin (EV)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gopakumar Iyer, MD
  • Phone Number: 646-888-4717

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Samuel Funt, MD
          • Phone Number: 646-888-4770
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
        • Contact:
          • Samuel Funt, MD
          • Phone Number: 646-888-4770
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
        • Contact:
          • Samuel Funt, MD
          • Phone Number: 646-888-4770
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
        • Contact:
          • Samuel Funt, MD
          • Phone Number: 646-888-4770
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Limited protocol activities)
        • Contact:
          • Samuel Funt, MD
          • Phone Number: 646-888-4770
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activites)
        • Contact:
          • Samuel Funt, MD
          • Phone Number: 646-888-4770
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited protocol activites)
        • Contact:
          • Samuel Funt, MD
          • Phone Number: 646-888-4770

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Since EV will be given per standard of care, we have not included inclusion criteria relevant to the safety of administering EV itself, since that will be left to the discretion of the treating clinician in a real-world, usual care setting, as is standard practice for non-therapeutic studies.

Description

Inclusion Criteria:

  • Written informed consent by and HIPAA authorization for release of personal health information obtained from the research participant.
  • Able to speak and read English to a sufficient level of fluency to provide informed consent and complete the study questionnaires.
  • Age ≥ 18 years at the time of consent.
  • ECOG Performance Status of ≤ 3 within 28 days prior to consent.
  • Histological or cytologically confirmed urothelial carcinoma.
  • Patients must be planned to start systemic therapy with enfortumab vedotin
  • At time of enrollment, patients must be planned to start enfortumab with or without pembrolizumab

Exclusion Criteria:

Subjects meeting any of the criteria below may not participate in the study:

  • Inability of the subject to understand and comply with study procedures.
  • Having previously received enfortumab vedotin
  • Students/employees of the study institution, pregnant women, prisoners, and institutionalized individuals (to prevent enrollment of vulnerable subjects).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants With Urothelial Carcinoma
Participants will have histological or cytologically confirmed urothelial carcinoma
Other: Non-therapeutic Nerve Conduction Studies
Non-invasive nerve conduction studies (NCS) offer an objective, quantitative approach to assess peripheral nerve function, particularly in sensory fibers, which are most commonly affected in chemotherapy-induced peripheral neuropathy/CIPN
Other: Non-therapeutic assessment of patient-reported neuropathy
To evaluate the incidence and severity of chemotherapy-induced peripheral neuropathy (CIPN) in participants receiving enfortumab vedotin, we will collect non-therapeutic, participant-reported outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Nerve Conduction Studies and patient reported neuropathy from baseline to 9 -15 weeks
Time Frame: up to 15 weeks
Describe change in Nerve Conduction Studies 9-15 weeks. An NCS measures the flow of electrical current through motor and sensory nerves. The primary outcome will be analyzed as a binary endpoint. Nerve conduction studies measure 9 domains, and if one domain changes from normal to abnormal between baseline and the second timepoint, the patient will be counted as experiencing a worsening neuropathy.
up to 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Samuel Funt, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

January 20, 2028

Study Completion (Estimated)

January 20, 2028

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-371

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urothelial Carcinoma

Clinical Trials on Non-therapeutic Nerve Conduction Studies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe