Immunotherapy in Upper Tract Urothelial Carcinoma
VESUVIO
Carcinomes urothéliaux Des Voies excrétrices supérieures traitées en Vie réelle Par immunothérapie (VESUVIO) : étude rétrospective Nationale
1 other identifier
observational
350
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedNovember 2, 2023
October 1, 2023
4 months
October 27, 2023
October 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival on anti-PD-(L)1 immunotherapy
2 years after immunotherapy initiation
Secondary Outcomes (9)
Best Objective Radiologic Response
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
- +4 more secondary outcomes
Study Arms (1)
Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy
Interventions
Non Applicable, research on data
Eligibility Criteria
Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy
You may qualify if:
- 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
You may not qualify if:
- Patient's opposition to this research
- Urothelial carcinoma of bladder or urethral primary site
- Non-urothelial tumor
- Maintenance immunotherapy initiated without disease progression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2023
First Posted
November 2, 2023
Study Start
November 1, 2023
Primary Completion
February 28, 2024
Study Completion
February 28, 2024
Last Updated
November 2, 2023
Record last verified: 2023-10