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.
Key facts
- Who runs it
- Centre Hospitalier Universitaire de Nīmes
- Where
- Nîmes, FranceSee the site
- Trial code
- 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
- Status
- Enrolling by invitation
- People taking part
- 50 people, planned
- Started
- 1 Jul 2026
- Expected to end
- 1 Jul 2027
- Type of study
- Observational
- Treatments tested
- enfortumab vedotin plus pembrolizumab in first line setting for advanced upper tract urothelial carcinoma
- Record updated
- 8 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The study looks back at adults with advanced cancer of the upper urinary tract who were treated with enfortumab vedotin plus pembrolizumab as their first treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced upper tract urothelial carcinoma (metastatic or locally advanced)
- Earlier treatment
- Must have had at least one infusion of enfortumab vedotin and pembrolizumab. Must not have had an immune checkpoint inhibitor before. Must not have had systemic treatment for advanced upper tract cancer before.
Main reasons for not taking part
- Earlier treatment with an immune checkpoint inhibitor
- Earlier systemic treatment for advanced upper tract urothelial carcinoma
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- advanced upper tract urothelial carcinoma treated with enfortumab vedotin and pembrolizumab
- at least one infusion of the treatment
Who cannot take part
- patient previously treated with immune checkpoint inhibitor
- patient previously treated with systemic treatment for advance UTUC
Where in France
- Centre Hospitalier UniversitaireNîmes, FranceNo longer taking part
About the trial
What the trial wants to find out
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
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.
Treatments tested
- enfortumab vedotin plus pembrolizumab in first line setting for advanced upper tract urothelial carcinoma
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Looking Back at Enfortumab Vedotin Plus Pembrolizumab for Advanced Upper Tract Urothelial CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 8 June 2026