Immunotherapy in Upper Tract Urothelial Carcinoma (VESUVIO)

October 27, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 2 years after immunotherapy initiation
2 years after immunotherapy initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Objective Radiologic Response
Time Frame: 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.
Up to 7 years maximum
Overall survival
Time Frame: 5 years after immunotherapy initiation
5 years after immunotherapy initiation
Progression free survival
Time Frame: 6 months after immunotherapy initiation
6 months after immunotherapy initiation
Progression free survival
Time Frame: 1 year after immunotherapy initiation
1 year after immunotherapy initiation
Progression free survival
Time Frame: 2 years after immunotherapy initiation
2 years after immunotherapy initiation
Progression free survival
Time Frame: 3 years after immunotherapy initiation
3 years after immunotherapy initiation
Duration of immunotherapy treatment
Time Frame: Up to 7 years after immunotherapy initiation
Treatment tolerability
Up to 7 years after immunotherapy initiation
Reasons for treatment discontinuation
Time Frame: Up to 7 years after immunotherapy initiation
Up to 7 years after immunotherapy initiation
Translational study of predictive biomarkers of efficacy
Time Frame: Up to 7 years after immunotherapy initiation
Up to 7 years after immunotherapy initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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