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

NCT07629700 | Not Yet Recruiting

• 2 other identifiers: ENDEAVORCE 30693_spe
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urothelial Carcinoma (UC); Peripheral Nerve Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 6 months after treatment initiation

Study Arms (1)

arm label

EXPERIMENTAL

Neuridase: Participants with locally advanced or metastatic urothelial carcinoma will receive standard-of-care enfortumab vedotin in combination with pembrolizumab together with supportive Neuridase according to the study protocol. Peripheral neuropathy symptoms, treatment tolerability, and patient-reported outcomes will be prospectively assessed during treatment.

Drug: enfortumab vedotin (EV); Drug: PEMBROLIZUMAB (alone or when added to a regimen above); Other: Neuridase

Interventions

enfortumab vedotin (EV) DRUG

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

arm label

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.

arm label

Neuridase OTHER

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

arm label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florence: lead
• Enfarma S.p.A.: collaborator

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Peripheral Nervous System Diseases

Interventions

enfortumab vedotin; pembrolizumab; Single Person

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Central Study Contacts

Lorenzo Antonuzzo, MD Phd, MD

CONTACT

055-5465353; lorenzo.antonuzzo@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share