VESUVIO: Immunotherapy in Upper Tract Urothelial Carcinoma

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06113367

Collaborator

(none)

350

Enrollment

3.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Urothelial Carcinoma	Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy

Study Design

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Overall survival on anti-PD-(L)1 immunotherapy [2 years after immunotherapy initiation]

Secondary Outcome Measures

Best Objective Radiologic Response [Up to 7 years maximum]
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.
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 [Up to 7 years after immunotherapy initiation]
Treatment tolerability
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT06113367

Other Study ID Numbers:

APHP230738

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 2, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Transitional Cell

Immunomodulating Agents

Study Results

No Results Posted as of Nov 2, 2023