Nerve effects of enfortumab vedotin in people with urothelial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults with confirmed urothelial carcinoma who are about to start enfortumab vedotin, with or without pembrolizumab. Participants will undergo non-therapeutic nerve conduction studies and complete standardized questionnaires about neuropathy at baseline and during treatment to track changes over time. Patients who have previously received enfortumab vedotin or who cannot complete the testing are excluded. Visits are conducted at Memorial Sloan Kettering locations in New Jersey and the data will be used to characterize the timing and severity of EV-associated neuropathy.

Why it matters

Who can join: the full rules

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).

Where it's running

• Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Samuel Funt, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Samuel Funt, MD
• Email: funts@mskcc.org
• Phone: 646-888-4770

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.