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

N/ANot Yet RecruitingNCT07629700

University of Florence40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Urothelial Carcinoma (UC)Peripheral Nerve Disease

Interventions

enfortumab vedotin (EV)DRUG

Standard-of-care enfortumab vedotin administered according to approved clinical practice.

PEMBROLIZUMAB (alone or when added to a regimen above)DRUG

Standard-of-care pembrolizumab administered in combination with enfortumab vedotin according to approved clinical practice.

NeuridaseOTHER

Supportive non-pharmacological product administered during treatment with enfortumab vedotin and pembrolizumab to prospectively explore peripheral neuropathy trajectory, tolerability, and patient-reported outcomes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary 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.

Time frame: From baseline to 6 months after treatment initiation