Looking Back at Enfortumab Vedotin Plus Pembrolizumab for Advanced Upper Tract Urothelial Cancer
Reviews past records of adults treated first with enfortumab vedotin plus pembrolizumab.
Plain-language title generated from the registry record
Registry title: Real-World Outcomes of First-Line Treatment of Metastatic or Locally Advanced Upper Tract Urothelial Carcinoma With Enfortumab Vedotin Plus Pembrolizumab : A French Multicenter Retrospective Observational Study
Key facts
- Where
- Nîmes, FranceSee the site
Where in France
- Centre Hospitalier UniversitaireNîmes, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire de Nīmes
- Trial code
- NCT07633353
- Record updated
- 8 June 2026
- Original description
The combination of Enfortumab Vedotin and Pembrolizumab has substantially improved outcomes for patients with advanced urothelial carcinoma and has emerged as a new standard of care in the first-line setting. However, data specifically regarding its use in patients with Upper Tract Urothelial Carcinoma (UTUC) remain limited.Read full original descriptionShow less
A French Multicenter Retrospective Observational Study Assessing the Efficacy and Safety of Enfortumab Vedotin Combined With Pembrolizumab in the First-Line Treatment of Patients With Metastatic or Locally Advanced Upper Tract Urothelial Carcinoma
The combination of Enfortumab Vedotin and Pembrolizumab has substantially improved outcomes for patients with advanced urothelial carcinoma and has emerged as a new standard of care in the first-line setting. However, data specifically regarding its use in patients with Upper Tract Urothelial Carcinoma (UTUC) remain limited.
This multicenter retrospective observational study aims to evaluate the real-world efficacy and safety of Enfortumab Vedotin plus Pembrolizumab as first-line treatment in patients with metastatic or locally advanced Upper Tract Urothelial Carcinoma (UTUC). The primary outcome will include objective response rate (ORR). Secondary outcomes will include progression-free survival (PFS), overall survival (OS), time to treatment response (TTR) and treatment-related toxicity.
In addition, the study will explore potential associations between clinical outcomes and selected molecular and immunohistochemical biomarkers, including Nectin-4 expression, microsatellite instability (MSI) status, and programmed death-ligand 1 (PD-L1) expression. These exploratory analyses may help identify predictive factors of response and contribute to a better understanding of treatment outcomes in this specific patient population.
Inclusion: advanced upper tract urothelial carcinoma treated with enfortumab vedotin and pembrolizumab; at least one infusion of the treatment.
Exclusion: patient previously treated with immune checkpoint inhibitor; patient previously treated with systemic treatment for advance UTUC.