Clinical Trial

Study of Peripheral Neuropathy in Patients With Advanced Urothelial Cancer Treated With Enfortumab Vedotin and Pembrolizumab With Supportive Neuridase (ENDEAVOR)

Study acronym: ENDEAVOR
Not Yet Recruiting
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Summary
his prospective exploratory study aims to describe the course of peripheral neuropathy in patients with locally advanced or metastatic urothelial carcinoma treated with enfortumab vedotin in combination with pembrolizumab and receiving supportive Neuridase. Peripheral neuropathy is a common adverse event associated with enfortumab vedotin and may negatively affect treatment tolerability, quality of life, and treatment continuation. Neuridase is a non-pharmacological supportive product intended to support peripheral nervous system function; however, its role in this clinical setting has not yet been established. Participants enrolled in this single-arm study will receive standard-of-care treatment with enfortumab vedotin plus pembrolizumab, together with supportive Neuridase according to clinical practice. The study will prospectively assess neuropathy symptoms and severity using clinical evaluations and patient-reported outcome measures, including quality-of-life questionnaires, over the course of treatment. The objective of the study is to explore neuropathy patterns and treatment tolerability in this patient population.
Trial Details
NCT Number NCT07629700
Lead Sponsor University of Florence
Collaborators: Enfarma S.p.A.
Conditions Urothelial Carcinoma (UC), Peripheral Nerve Disease
Enrollment 40 participants
Start Date 2026-09-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2028-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-08