Peripheral Nerve Disease, Urothelial Carcinoma (UC)
Conditions
Brief 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.
Interventions
Standard-of-care enfortumab vedotin administered according to approved clinical practice.
Standard-of-care pembrolizumab administered in combination with enfortumab vedotin according to approved clinical practice.
OTHERNeuridase
Supportive non-pharmacological product administered during treatment with enfortumab vedotin and pembrolizumab to prospectively explore peripheral neuropathy trajectory, tolerability, and patient-reported outcomes.
Sponsors
University of Florence
Enfarma S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
IInclusion Criteria: * 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 * Adequate clinical conditions to participate in the study according to investigator judgment
Exclusion criteria
* 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 * Any medical, psychiatric, or social condition that, in the investigator's judgment, may interfere with study participation or interpretation of results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Peripheral Neuropathy | From baseline to 6 months after treatment initiation | 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. |
Contacts
CONTACTLorenzo Antonuzzo, MD Phd, MD
Outcome results
None listed