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RecruitingObservational

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

NCT ID: NCT07390617Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-05-29

Summary

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)

Arms & interventions

  • OtherNon-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

  • OtherNon-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

Outcome measures

Primary

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

    Time frame: up to 15 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (7)

Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
Samuel Funt, MD · Contact

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Samuel Funt, MD · Contact

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
Samuel Funt, MD · Contact

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725

Recruiting
Samuel Funt, MD · Contact

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

Recruiting
Samuel Funt, MD · Contact

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, 10065

Recruiting
Samuel Funt, MD · Contact

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553

Recruiting
Samuel Funt, MD · Contact