Interrogating Enfortumab Vedotin-associated Neuropathy in Patients With Metastatic or Muscle-Invasive Urothelial Carcinoma Receiving Enfortumab Vedotin
Summary
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)
Arms & interventions
- OtherNon-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
- OtherNon-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
Outcome measures
Primary
Change in Nerve Conduction Studies and patient reported neuropathy from baseline to 9 -15 weeks
Describe change in Nerve Conduction Studies 9-15 weeks. An NCS measures the flow of electrical current through motor and sensory nerves. The primary outcome will be analyzed as a binary endpoint. Nerve conduction studies measure 9 domains, and if one domain changes from normal to abnormal between baseline and the second timepoint, the patient will be counted as experiencing a worsening neuropathy.
Time frame: up to 15 weeks
Eligibility criteria
Study locations (7)
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553