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

{ "Observational Study of Neuropathy with Enfortumab Vedotin in Urothelial Carcinoma", "This study is looking at how nerve test results change in people with urothelial carcinoma (a type of bladder cancer) who are being treated with enfortumab vedotin. Researchers will use non-invasive nerve conduction studies (NCS) to measure nerve function and also ask you about your experience with neuropathy (nerve damage) symptoms. The goal is to understand the incidence and severity of neuropathy caused by enfortumab vedotin. This study is for adults aged 18 and older who can read and speak English. The study will measure changes in nerve tests and patient-reported neuropathy from the start of the study up to 15 weeks later. The current recruitment status is unclear.", "design": "This is an observational study planning to enroll 50 participants. It is not a treatment study, but rather observes the effects of an existing treatment.", "commitments": "You would undergo non-invasive nerve conduction studies and complete questionnaires about your neuropathy symptoms. These assessments will occur from the start of the study up to 15 weeks later.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for changes in nerve tests and reported neuropathy for up to 15 weeks.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07390617

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

Recruiting
Not specifiedAges 18+Observational
Memorial Sloan Kettering Cancer Center
~50 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Non-therapeutic Nerve Conduction StudiesNon-therapeutic assessment of patient-reported neuropathy

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Nerve Conduction Studies and patient reported neuropathy from baseline to 9 -15 weeks
Measured over up to 15 weeks

Conditions

Neuropathy
Urothelial Carcinoma
Metastatic Urothelial Carcinoma

Explore related trials

Urothelial Carcinoma

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Samuel Funt, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Samuel Funt, MD
[email protected]
646-888-4770
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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Change in Nerve Conduction Studies and patient reported neuropathy from baseline to 9 -15 weeksup 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.