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Active Not RecruitingNCT07063758

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

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
National Taiwan University Clinical Trial Center · Academic / Other
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERBiomarker AnalysisTumor 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.

Timeline

Start date
2025-04-01
Primary completion
2029-09-30
Completion
2029-12-31
First posted
2025-07-14
Last updated
2025-07-16

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT07063758. Inclusion in this directory is not an endorsement.