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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07633353

Acronym

UTUC PROVE

Enrollment

Registered

2026-06-08

Start date

2026-07-01

Completion date

2027-07-01

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Upper Tract Urothelial Carcinoma

Keywords

enfortumab-vedotin, pembrolizumab

Brief 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.

Interventions

DRUGenfortumab 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)

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
objective response rate	number of patients presenting with treatment response from the beginning of the treatment to at least 6 months follow up

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026