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
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Taipei, Taiwan
- National Taiwan University Hospital
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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:
- Age ≥ 20 y/o
- Histologically confirmed urothelial carcinoma
- Radiologically documented locally advanced or metastatic disease
- Exposure to EV (as monotherapy or in combination with pembrolizumab) or first-line platinum-based chemotherapy
- Complete and identifiable medical records
Exclusion Criteria:
- Inadequate or insufficient tumor tissues for analyses
- 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.
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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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Objective Response Rate (ORR)
Time Frame: Up to 12 months after treatment initiation
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Proportion of patients achieving complete or partial tumor response according to RECIST 1.1 criteria after enfortumab vedotin treatment.
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Up to 12 months after treatment initiation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-Free Survival (PFS)
Time Frame: Up to 24 months
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Time from treatment start to disease progression or death from any cause.
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Up to 24 months
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Overall Survival (OS)
Time Frame: Up to 36 months
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Time from treatment initiation to death from any cause.
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Up to 36 months
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Treatment-Related Adverse Events
Time Frame: Up to 36 months
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Incidence and severity of adverse events graded by CTCAE v5.0 during treatment.
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Up to 36 months
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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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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
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