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NCT Number: NCT07629700

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

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.

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Key information

Conditions

Urothelial Carcinoma (UC) Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Nervous System Diseases Neuromuscular Diseases Peripheral Nerve Disease Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

Incidence and Severity of Peripheral Neuropathy

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Antonuzzo, MD Phd, MD

CONTACT

[email protected]

055-5465353

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

Enfarma S.p.A.

Registry information

Official study title

ENDEAVOR Study: A Prospective Exploratory Study Describing the Course of Peripheral Neuropathy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin in Combination With Pembrolizumab and Supportive Neuridase

Acronym: ENDEAVOR

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Jun 5, 2026
Registry last updated: Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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