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

National Taiwan University Clinical Trial Center

Status: Active, not recruiting

Conditions: Advanced Urothelial Carcinoma

Treatments: Other: Biomarker Analysis

Study type: Observational

Funder types: Other

Identifiers

NCT07063758

202502065RINE

Details and patient eligibility

About

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.

Enrollment: 200 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. 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

Trial design

200 participants in 2 patient groups

EV Therapy Cohort

Description:

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.

Treatment:

Other: Biomarker Analysis

Chemotherapy Cohort

Description:

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.

Treatment:

Other: Biomarker Analysis