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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

NCT07633353 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-06-08

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Upper Tract Urothelial Carcinoma

Interventions

DRUG

enfortumab vedotin plus pembrolizumab in first line setting for advanced upper tract urothelial carcinoma

enfortumab vedotin plus pembrolizumab for advanced upper tract urothelial carcinoma, from september 2024 (time of the French ATU) to december 2025 (time of inclusion minus 6 months follow up)

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-01
Completion
2027-07-01
FDA Drug
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07633353 on ClinicalTrials.gov