Real-World Outcomes of First-Line Treatment of Metastatic... | NCT07633353

Studies
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

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Enrolling by invitation

Last Update Posted

Jun 8, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Advanced Upper Tract Urothelial Carcinoma

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Jul 1, 2027Estimated

First Submitted Date

Jun 3, 2026

First Submission Date that Met QC Criteria

Jun 3, 2026

First Posted Date

Jun 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2026

Last Update Posted Date

Jun 8, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Clémence Goy, Intern, Centre Hospitalier Universitaire de NīmesPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
enfortumab vedotin plus pembrolizumab in first line setting for advanced upper tract urothelial carcinoma	Drug	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)

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adults > 18 years old with histologically confirmed metastatic or locally advanced urothelial carcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire		Nîmes		30000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38446675	Background	Powles T, Valderrama BP, Gupta S, Bedke J, Kikuchi E, Hoffman-Censits J, Iyer G, Vulsteke C, Park SH, Shin SJ, Castellano D, Fornarini G, Li JR, Gumus M, Mar N, Loriot Y, Flechon A, Duran I, Drakaki A, Narayanan S, Yu X, Gorla S, Homet Moreno B, van der Heijden MS; EV-302 Trial Investigators. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):875-888. doi: 10.1056/NEJMoa2312117.

ID	Term
C000632577	enfortumab vedotin
C582435	pembrolizumab