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.
Age ≥18 years
Histologically confirmed locally advanced or metastatic urothelial carcinoma
Candidate for treatment with enfortumab vedotin in combination with pembrolizumab according to clinical practice
Ability to provide written informed consent
Pre-existing severe peripheral neuropathy that may interfere with study assessments
Contraindications to enfortumab vedotin or pembrolizumab according to clinical practice
Known hypersensitivity to components of Neuridase
Pregnancy or breastfeeding
Single group
enfortumab vedotin (EV)
DrugStandard-of-care enfortumab vedotin administered according to approved clinical practice.
PEMBROLIZUMAB (alone or when added to a regimen above)
DrugStandard-of-care pembrolizumab administered in combination with enfortumab vedotin according to approved clinical practice.
Neuridase
Other interventionSupportive non-pharmacological product administered during treatment with enfortumab vedotin and pembrolizumab to prospectively explore peripheral neuropathy trajectory, tolerability, and patient-reported outcomes.
Incidence and Severity of Peripheral Neuropathy
Incidence and severity of peripheral neuropathy will be prospectively assessed according to clinical evaluation and CTCAE criteria in patients receiving enfortumab vedotin plus pembrolizumab with supportive Neuridase.
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University of Florence
Lead sponsor
Enfarma S.p.A.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
