Recruiting

Enfortumab Vedotin

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07390617

Conditions

Neuropathy

Urothelial Carcinoma

Metastatic Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-therapeutic Nerve Conduction Studies

Non-therapeutic assessment of patient-reported neuropathy

Study Details

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)

Conditions

Neuropathy

Urothelial Carcinoma

Metastatic Urothelial Carcinoma

Study ID

NCT07390617

Start date

Jan 20, 2026

Status verified date

May, 2026

Completion date

Jan 20, 2028

Anticipated

Primary completion date

Jan 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants With Urothelial Carcinoma

Participants will have histological or cytologically confirmed urothelial carcinoma

Interventions

Non-therapeutic Nerve Conduction Studies

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

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 outcome measure

  • Change in Nerve Conduction Studies and patient reported neuropathy from baseline to 9 -15 weeks [ Time Frame: up to 15 weeks ]

Central Contacts and Locations

Central contacts

Samuel Funt, MD

646-888-4770funts@mskcc.org

Gopakumar Iyer, MD

646-888-4717

Locations

Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Samuel Funt, MD

646-888-4770

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Samuel Funt, MD

646-888-4770

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Samuel Funt, MD

646-888-4770

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Samuel Funt, MD

646-888-4770

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Samuel Funt, MD

646-888-4770

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Samuel Funt, MD

646-888-4770

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Samuel Funt, MD

646-888-4770

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • urothelial carcinoma
  • metastatic urothelial carcinoma
  • neuropathy
  • Memorial Sloan Kettering Cancer Center
  • 25-371

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-29.