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NCT Number: NCT07063758

A Biomarker Study 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Urothelial Carcinoma

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 12 months after treatment initiation

    Proportion of patients achieving complete or partial tumor response according to RECIST 1.1 criteria after enfortumab vedotin treatment.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to 24 months

    Time from treatment start to disease progression or death from any cause.

  2. Overall Survival (OS)

    Time frame: Up to 36 months

    Time from treatment initiation to death from any cause.

  3. Treatment-Related Adverse Events

    Time frame: Up to 36 months

    Incidence and severity of adverse events graded by CTCAE v5.0 during treatment.

  4. 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

    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

Sponsors and collaborators

Lead sponsor

National Taiwan University Clinical Trial Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 14, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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