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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07390617
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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)

Key Dates

Start date
Jan 20, 2026
Status verified
May 2026
Primary completion
Jan 20, 2028
Completion
Jan 20, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Participants With Urothelial Carcinoma
    Participants will have histological or cytologically confirmed urothelial carcinoma

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

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)CommackNew York11725
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Cancer Center (All Protocol Activites)New YorkNew York10065
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Nassau (Limited Protocol Activites)Rockville CentreNew York11553
Samuel Funt, MD
646-888-4770

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Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activites)· New York, NY

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