A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma
Interrogating Enfortumab Vedotin-associated Neuropathy in Patients With Metastatic Urothelial Carcinoma Receiving Enfortumab Vedotin
Memorial Sloan Kettering Cancer Center
50 participants
Jan 20, 2026
OBSERVATIONAL
Conditions
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)
Eligibility
Inclusion Criteria7
- 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 Criteria4
- 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).
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Interventions
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
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
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07390617