A Biomarker Study to Predict Treatment Outcomes of Enfortumab Vedotin in Advanced Urothelial Carcinoma
NCT ID: NCT07063758
Last Updated: 2025-07-16
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2025-04-01
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Incomplete medical records
20 Years
ALL
No
Sponsors
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National Taiwan University Clinical Trial Center
OTHER
Responsible Party
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National Taiwan University Clinical Trial Center
National Taiwan University Hospital Clinical Trial Center
Principal Investigators
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Fu-Jen Hsueh, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Medical Oncology, National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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Powles T, Valderrama BP, Gupta S, Bedke J, Kikuchi E, Hoffman-Censits J, Iyer G, Vulsteke C, Park SH, Shin SJ, Castellano D, Fornarini G, Li JR, Gumus M, Mar N, Loriot Y, Flechon A, Duran I, Drakaki A, Narayanan S, Yu X, Gorla S, Homet Moreno B, van der Heijden MS; EV-302 Trial Investigators. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):875-888. doi: 10.1056/NEJMoa2312117.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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202502065RINE
Identifier Type: -
Identifier Source: org_study_id
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