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NCT Number: NCT07072637

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

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.

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Key information

Conditions

Locally Advanced or Metastatic Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location contact

Fu-Jen Hsueh, M.D.

CONTACT

[email protected]

02-23123456 ext. 66001

Fu-Jen Hsueh, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Do not agree to receive regular neurological examinations
  • Do not agree to provide complete medical records during treatment

Treatment and study plan

Neurological function assessment

Diagnostic Test

Neurological evaluations including neurological examination (NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. Assessments will be conducted at baseline and every three months until six months after completion of EV treatment.

Primary outcomes

  1. Correlation between neurological function and subjective peripheral neuropathy symptoms

    Time frame: Baseline to 6 months post-treatment.

    Correlation between objective neurological assessments (nerve conduction study, QST, autonomic function tests, TCNS) and patient-reported peripheral neuropathy symptoms.

Secondary outcomes

  1. Correlation between neurological function changes and oncological outcomes

    Time frame: From date of EV initiation to the date of death from any cause, assessed up to 36 months

    To evaluate whether the degree or pattern of neurological function changes (e.g., worsening in NCS, QST) correlates with clinical efficacy measures such as objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).

Study contacts

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

Fu-Jen Hsueh, M.D.

CONTACT

[email protected]

02-23123456 ext. 66001

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

A Prospective Study Assessing Neurological Function and Its Clinical Implications in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Receiving Enfortumab Vedotin-Based Therapy

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

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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