A Biomarker Study to Predict Treatment Outcomes of Enfortumab Vedotin in Advanced Urothelial Carcinoma

July 13, 2025 updated by: National Taiwan University Clinical Trial Center

Biomarker Studies to Predict Treatment Outcomes of Enfortumab Vedotin in Advanced Urothelial Carcinoma

This study aims to find biological markers that help predict how patients with advanced urothelial carcinoma respond to treatment with enfortumab vedotin (EV) or EV-based combination therapies. Since EV can cause significant side effects and is costly, identifying markers such as nectin-4 and related proteins in tumor tissue and blood may help doctors personalize treatment plans. The investigators will enroll about 100 patients receiving EV and compare them to another 100 patients treated with standard chemotherapy. By studying tissue samples and blood at different times, the investigators hope to discover which markers best indicate treatment success or risks. This research could lead to better, safer treatments tailored to each patient's biology.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with advanced urothelial carcinoma receiving enfortumab vedotin-based therapies or first-line platinum-based chemotherapy. Participants will be adults aged 20 years or older, of any sex, with available archival tumor tissue and serum samples for biomarker analyses. Patients must have adequate organ function and no prior treatment with enfortumab vedotin.

Description

Inclusion Criteria:

  1. Age ≥ 20 y/o
  2. Histologically confirmed urothelial carcinoma
  3. Radiologically documented locally advanced or metastatic disease
  4. Exposure to EV (as monotherapy or in combination with pembrolizumab) or first-line platinum-based chemotherapy
  5. Complete and identifiable medical records

Exclusion Criteria:

  1. Inadequate or insufficient tumor tissues for analyses
  2. Incomplete medical records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EV Therapy Cohort
Patients with advanced urothelial carcinoma who receive enfortumab vedotin-based therapies. Tumor tissue and serum samples will be collected and analyzed for membranous Nectin-4, ADAM10/17, and soluble Nectin-4 (sNectin-4) to assess their association with treatment outcomes.
Other: Biomarker Analysis
Tumor tissue and serum samples will be collected and analyzed to evaluate the expression of membranous Nectin-4, ADAM10/17, and levels of soluble Nectin-4 (sNectin-4) as predictive biomarkers in patients with advanced urothelial carcinoma receiving standard therapies.
Chemotherapy Cohort
Patients with advanced urothelial carcinoma who receive platinum-based chemotherapy. Tumor tissue and serum samples will be collected and analyzed for membranous Nectin-4, ADAM10/17, and soluble Nectin-4 (sNectin-4) to assess their association with treatment outcomes.
Other: Biomarker Analysis
Tumor tissue and serum samples will be collected and analyzed to evaluate the expression of membranous Nectin-4, ADAM10/17, and levels of soluble Nectin-4 (sNectin-4) as predictive biomarkers in patients with advanced urothelial carcinoma receiving standard therapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 12 months after treatment initiation
Proportion of patients achieving complete or partial tumor response according to RECIST 1.1 criteria after enfortumab vedotin treatment.
Up to 12 months after treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to 24 months
Time from treatment start to disease progression or death from any cause.
Up to 24 months
Overall Survival (OS)
Time Frame: Up to 36 months
Time from treatment initiation to death from any cause.
Up to 36 months
Treatment-Related Adverse Events
Time Frame: Up to 36 months
Incidence and severity of adverse events graded by CTCAE v5.0 during treatment.
Up to 36 months
Association of Nectin-4, ADAM10/17 Expression and Serum Soluble Nectin-4 with Overall Survival, Progression-Free Survival, Objective Response Rate, and Adverse Events
Time Frame: Assessed at baseline and up to 36 months

To evaluate the correlation between baseline membranous Nectin-4 expression, ADAM10/17 expression (by immunohistochemistry), and serum soluble Nectin-4 levels (by ELISA) with clinical outcomes, including:

Overall survival (OS)

Progression-free survival (PFS)

Objective response rate (ORR) assessed by RECIST v1.1

Treatment-related adverse events graded by CTCAE v5.0
Assessed at baseline and up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Clinical Trial Center

Investigators

  • Principal Investigator: Fu-Jen Hsueh, M.D., Department of Medical Oncology, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

June 24, 2025

First Submitted That Met QC Criteria

July 2, 2025

First Posted (Actual)

July 14, 2025

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202502065RINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) will be made available upon reasonable request after publication of the primary results. Data sharing will follow applicable ethical and privacy regulations. Requests can be directed to the Principal Investigator and will require a data use agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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