Immunotherapy in Upper Tract Urothelial Carcinoma (VESUVIO)

Carcinomes urothéliaux Des Voies excrétrices supérieures traitées en Vie réelle Par immunothérapie (VESUVIO) : étude rétrospective Nationale

Upper-tract urothelial carcinoma (UTUC) is a rare tumor. Standard treatment of localized disease is most often radical nephroureterectomy.

In advanced/metastatic disease, treatments follow the standards for urothelial carcinoma including platinum-based chemotherapy and anti-PD(L)1 (Programmed death (ligand) 1) immunotherapy, with no regard as to the primary disease site (bladder or upper tract). Given the rarity of UTUC, efficacy data in the UTUC subgroup of advanced urothelial carcinoma is scarce.

UTUC show distinct pahological and molecular features, including higher prevalence of microsatellite instability and of abnormalities in the FGFR (fibroblast growth factor receptors) gene family. These specific features may impact outcomes of immunotherapy in advanced/metastatic UTUC.

Study Overview

• Status: Not yet recruiting
• Conditions: Urothelial Carcinoma
• Intervention / Treatment: Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, Pr; Phone Number: +33142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: Clément Dumont, Dr; Phone Number: +142494217; Email: clement.dumont@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy

Description

Inclusion Criteria:

• Age 18 and more
• Diagnosis of urothelial carcinoma (with or without variant histology)
• Advanced/metastatic disease not amenable to local treatment with curative intent
• Treatment with an anti-PD-(L)1 monoclonal antibody initiated between 2016 and 2022

Exclusion Criteria:

• Patient's opposition to this research
• Urothelial carcinoma of bladder or urethral primary site
• Non-urothelial tumor
• Maintenance immunotherapy initiated without disease progression

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy	Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy; Non Applicable, research on data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival on anti-PD-(L)1 immunotherapy	2 years after immunotherapy initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Objective Radiologic Response	Evaluated by RECIST v1.1 The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard system to measure how cancer responds to different treatments.It permits to evaluate the response according to the evolution of the lesions.	Up to 7 years maximum
Overall survival		5 years after immunotherapy initiation
Progression free survival		6 months after immunotherapy initiation
Progression free survival		1 year after immunotherapy initiation
Progression free survival		2 years after immunotherapy initiation
Progression free survival		3 years after immunotherapy initiation
Duration of immunotherapy treatment	Treatment tolerability	Up to 7 years after immunotherapy initiation
Reasons for treatment discontinuation		Up to 7 years after immunotherapy initiation
Translational study of predictive biomarkers of efficacy		Up to 7 years after immunotherapy initiation

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: APHP230738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No