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

Enrolling by invitation

Conditions studied: Advanced Upper Tract Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT07633353

Run by

Centre Hospitalier Universitaire de Nīmes

People needed

50

Starts

2026-07-01

Expected to finish

2027-07-01

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• advanced upper tract urothelial carcinoma treated with enfortumab vedotin and pembrolizumab
• at least one infusion of the treatment

You may not qualify if…

• patient previously treated with immune checkpoint inhibitor
• patient previously treated with systemic treatment for advance UTUC

Where it is running

• Centre Hospitalier Universitaire — Nîmes, France

Full record on ClinicalTrials.gov

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