A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Participants With Urothelial Carcinoma | Participants will have histological or cytologically confirmed urothelial carcinoma |
|
Recruiting Locations
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Contact:
Samuel Funt, MD
646-888-4770
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Contact:
Samuel Funt, MD
646-888-4770
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Contact:
Samuel Funt, MD
646-888-4770
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York 11725
Commack, New York 11725
Contact:
Samuel Funt, MD
646-888-4770
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
Harrison, New York 10604
Contact:
Samuel Funt, MD
646-888-4770
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York 10065
New York, New York 10065
Contact:
Samuel Funt, MD
646-888-4770
Samuel Funt, MD
646-888-4770
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York 11553
Rockville Centre, New York 11553
Contact:
Samuel Funt, MD
646-888-4770
Samuel Funt, MD
646-888-4770
More Details
- Status
- Recruiting
- Sponsor
- Memorial Sloan Kettering Cancer Center