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

ArmDescriptionAssigned Intervention
Participants With Urothelial Carcinoma Participants will have histological or cytologically confirmed urothelial carcinoma
  • Other: Non-therapeutic Nerve Conduction Studies
    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
  • Other: Non-therapeutic assessment of patient-reported neuropathy
    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

Recruiting Locations

Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
Contact:
Samuel Funt, MD
646-888-4770

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748
Contact:
Samuel Funt, MD
646-888-4770

Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
Contact:
Samuel Funt, MD
646-888-4770

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York 11725
Contact:
Samuel Funt, MD
646-888-4770

Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
Contact:
Samuel Funt, MD
646-888-4770

Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York 10065
Contact:
Samuel Funt, MD
646-888-4770

Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York 11553
Contact:
Samuel Funt, MD
646-888-4770

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Samuel Funt, MD
646-888-4770
funts@mskcc.org