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

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)

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Key information

Conditions

Neuropathy Carcinoma Carcinoma, Transitional Cell Metastatic Urothelial Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Non-therapeutic Nerve Conduction Studies

Other

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

Non-therapeutic assessment of patient-reported neuropathy

Other

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

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gopakumar Iyer, MD

CONTACT

646-888-4717

Samuel Funt, MD

CONTACT

[email protected]

646-888-4770

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Feb 5, 2026
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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