Nerve effects of enfortumab vedotin in people with urothelial cancer
Interrogating Enfortumab Vedotin-associated Neuropathy in Patients With Metastatic Urothelial Carcinoma Receiving Enfortumab Vedotin
We will see how nerve testing and patient-reported symptoms change in adults with urothelial cancer who are starting enfortumab vedotin.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | enfortumab, pembrolizumab |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT07390617 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed urothelial carcinoma who are planning to start enfortumab vedotin (with or without pembrolizumab), can read English, provide informed consent, and have ECOG performance status ≤3 are ideal candidates.
Not a fit: People who have already received enfortumab vedotin, cannot complete nerve conduction studies or questionnaires, are pregnant, incarcerated, institutionalized, or unable to provide consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could help clinicians detect and monitor enfortumab vedotin–related nerve damage earlier and guide changes in care to reduce long-term neuropathy.
How similar studies have performed: Nerve conduction testing and patient-reported outcome tracking have been used to monitor chemotherapy-related neuropathy in other cancers, but prospective data specific to enfortumab vedotin remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basking Ridge, New Jersey and 6 other locations
- 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)
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Lage, MD, MBA, MS — Memorial Sloan Kettering Cancer Center
- Study coordinator: Daniel Lage, MD, MBA, MS
- Email: laged1@mskcc.org
- Phone: 646-888-5418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.