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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker Analysis | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time from treatment start to disease progression or death from any cause. | Up to 24 months |
| Overall Survival (OS) | Time from treatment initiation to death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Fu-Jen Hsueh, M.D. | Department of Medical Oncology, National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38446675 | Background | 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. |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 19, 2025 | Jul 2, 2025 | Prot_000.pdf |
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Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples and peripheral blood samples (serum) will be retained. Tumor tissues will be used for immunohistochemical analysis of membranous Nectin-4 and ADAM10/17 expression. Serum samples will be collected at predefined time points during treatment to measure soluble Nectin-4 (sNectin-4) levels. Samples may also be used in future biomarker studies, including DNA-based analyses.
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| Up to 36 months |
| Treatment-Related Adverse Events | 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 | 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 |