Recruiting

Enfortumab Vedotin-associated Neuropathy Changes in Metastatic Urothelial Carcinoma Patients

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Study Aim

This observational study aims to monitor changes in nerve function, using Nerve Conduction Studies, from the start to 12-15 weeks in patients with metastatic urothelial carcinoma who are receiving Enfortumab Vedotin treatment.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Carcinoma+2

+ Carcinoma, Transitional Cell

+ Neoplasms

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2026
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Study ContactDaniel Lage, MD, MBA, MSMore contacts
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 20, 2026

Actual date on which the first participant was enrolled.

This study focuses on individuals diagnosed with urothelial cancer, a type of cancer that affects the urinary system. The main goal is to understand how treatment with a drug called enfortumab vedotin (EV) impacts the nerves. This is important because it can help doctors better manage any nerve-related side effects of the treatment and improve patient care. During the study, participants receive enfortumab vedotin as part of their treatment. To monitor the effects on the nerves, a test called Nerve Conduction Studies (NCS) is performed. This test measures how well electrical signals travel through the nerves. The study records changes in these signals from the start of the treatment up to 12-15 weeks later. This information helps determine how the drug affects nerve function over time.

Official TitleInterrogating Enfortumab Vedotin-associated Neuropathy in Patients With Metastatic Urothelial Carcinoma Receiving Enfortumab Vedotin
NCT07390617
Principal SponsorMemorial Sloan Kettering Cancer Center
Study ContactDaniel Lage, MD, MBA, MSMore contacts
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaCarcinoma, Transitional CellNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and Epithelial

Criteria

7 inclusion criteria required to participate
At time of enrollment, patients must be planned to start enfortumab with or without pembrolizumab
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.
Show More Criteria
3 exclusion criteria prevent from participating
Having previously received enfortumab vedotin
Inability of the subject to understand and comply with study procedures.
Students/employees of the study institution, pregnant women, prisoners, and institutionalized individuals (to prevent enrollment of vulnerable subjects).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Recruiting

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

Basking Ridge, United StatesOpen Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities) in Google Maps
Recruiting

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, United States
Recruiting

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, United States
Recruiting

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, United States
Recruiting
7 Study Centers
Enfortumab Vedotin-associated Neuropathy Changes in Metastatic Urothelial Carcinoma Patients | PatLynk