Neurological Function in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin-Based Therapy

National Taiwan University

Status: Not yet enrolling

Conditions: Locally Advanced or Metastatic Urothelial Carcinoma

Treatments: Diagnostic Test: Neurological function assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07072637

202502005RINB

Details and patient eligibility

About

This prospective observational study aims to evaluate the correlation between neurological function and patient-reported symptoms of peripheral neuropathy (PN) in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) receiving enfortumab vedotin (EV)-based therapy. A total of 100 patients will be enrolled between March 2025 and December 2029. Eligible participants will undergo comprehensive neurological assessments, including neurological examination(NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. These assessments will be conducted at baseline and every three months until six months after completion of EV-based therapy. Patient characteristics and oncological outcomes will also be collected. This study seeks to identify risk factors for developing PN and to explore the clinical implications of EV-associated neurological changes, with the ultimate goal of optimizing treatment strategies and improving quality of life.

Full description

Peripheral neuropathy (PN) is a frequent and often debilitating adverse event associated with enfortumab vedotin (EV), a NECTIN-4-directed antibody-drug conjugate approved for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). While EV has demonstrated significant antitumor efficacy, the objective assessment of PN and its clinical implications remain insufficiently explored. This prospective observational study aims to comprehensively evaluate neurological function and its correlation with subjective PN symptoms in la/mUC patients receiving EV-based therapy.

A total of 100 patients will be prospectively enrolled between March 2025 and December 2029. Neurological assessments will include neurological neurological examination (NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. These evaluations will be conducted at baseline and every three months until six months post-EV treatment. Clinical data, including patient characteristics and oncologic outcomes, will also be collected.

This study aims to identify predictive factors for EV-related PN and to evaluate the broader clinical implications of neurological function changes. The ultimate goal is to inform strategies for toxicity mitigation and to optimize therapeutic outcomes and quality of life in la/mUC patients.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 20 y/o
2. Histologically confirmed urothelial carcinoma
3. Radiologically documented locally advanced or metastatic disease
4. Prepare for receiving EV (as monotherapy or in combination with immune checkpoint inhibitors)
5. Complete and identifiable medical records

Exclusion criteria

1. Do not agree to receive regular neurological examinations
2. Do not agree to provide complete medical records during treatment

Trial design

100 participants in 1 patient group

EV-based therapy

Description:

Patients with locally advanced or metastatic urothelial carcinoma receiving enfortumab vedotin-based therapy

Treatment:

Diagnostic Test: Neurological function assessment