Actively Recruiting

Age: 18Years +
All Genders
ID07390617

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-29

50

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how nerve test results change in people with urothelial carcinoma who are treated with enfortumab vedotin. This observational study focuses on assessing nerve function and patient-reported neuropathy in individuals with metastatic or muscle-invasive urothelial carcinoma. The study is led by Memorial Sloan Kettering Cancer Center and aims to understand chemotherapy-induced peripheral neuropathy linked to this treatment. Participants will undergo non-invasive nerve conduction studies to objectively measure nerve function, especially in sensory fibers affected by neuropathy. They will also provide self-reported information about their neuropathy symptoms. The study includes individuals planned to start systemic therapy with enfortumab vedotin, with or without pembrolizumab. During the study, nerve conduction tests and questionnaires about neuropathy will be collected from baseline up to 9 to 15 weeks. Researchers will monitor changes in nerve function and neuropathy severity over this period. Participants must be able to communicate in English and have a performance status allowing study participation. The study does not involve therapeutic interventions but focuses on observation and assessment of nerve health during treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent and HIPAA authorization obtained
  • Able to speak and read English sufficiently to provide consent and complete questionnaires
  • Age 18 years or older at time of consent
  • ECOG Performance Status of 3 or less within 28 days before consent
  • Histological or cytologically confirmed urothelial carcinoma
  • Planned to start systemic therapy with enfortumab vedotin
  • At enrollment, planned to start enfortumab vedotin with or without pembrolizumab
Not Eligible

You will not qualify if you...

  • Unable to understand or comply with study procedures
  • Prior treatment with enfortumab vedotin
  • Students or employees of the study institution
  • Pregnant women
  • Prisoners or institutionalized individuals

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 15 weeks

Participants undergo non-invasive nerve conduction studies and report on neuropathy symptoms while receiving enfortumab vedotin treatment.

Multiple visits during treatment up to 15 weeks

Trial Site Locations

Total: 7 locations

1

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

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

S

Samuel Funt, MD

G

Gopakumar Iyer, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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