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

Memorial Sloan Kettering Cancer Center (MSK)

Status

Enrolling

Conditions

Urothelial Carcinoma

Metastatic Urothelial Carcinoma

Neuropathy

Treatments

Other: Non-therapeutic assessment of patient-reported neuropathy

Other: Non-therapeutic Nerve Conduction Studies

Study type

Observational

Funder types

Other

Identifiers

NCT07390617

25-371

Details and patient eligibility

About

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)

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).