RECRUITINGOBSERVATIONAL
A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma
Interrogating Enfortumab Vedotin-associated Neuropathy in Patients With Metastatic Urothelial Carcinoma Receiving Enfortumab Vedotin
About This Trial
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)
Who May Be Eligible (Plain English)
Who May Qualify:
- Written willing to sign a consent form 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 willing to sign a consent form 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
Who Should NOT Join This Trial:
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).
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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).
Treatments Being Tested
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
Locations (7)
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States