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
1 other identifier
observational
50
1 country
7
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2026
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2026
CompletedFirst Submitted
Initial submission to the registry
January 21, 2026
CompletedFirst Posted
Study publicly available on registry
February 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 20, 2028
February 5, 2026
January 1, 2026
2 years
January 21, 2026
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Nerve Conduction Studies/NCS from baseline to 12-15 weeks
Describe change in Nerve Conduction Studies/NCS from baseline to 12-15 weeks. An NCS measures the flow of electrical current through motor and sensory nerves.
up to 4 months
Study Arms (1)
Participants With Urothelial Carcinoma
Participants will have histological or cytologically confirmed urothelial carcinoma
Interventions
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
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Lage, MD, MBA, MS
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2026
First Posted
February 5, 2026
Study Start
January 20, 2026
Primary Completion (Estimated)
January 20, 2028
Study Completion (Estimated)
January 20, 2028
Last Updated
February 5, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
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.