Immunotherapy in Upper Tract Urothelial Carcinoma

Urothelial Carcinoma Clinical Trial

— VESUVIO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06113367
• Other study ID #: APHP230738
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Clément Dumont, Dr
• Phone: +142494217
• Email: clement.dumont[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Other:
• Evaluation of anti-PD-(L)1 immunotherapy efficacy
Non Applicable, research on data

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival on anti-PD-(L)1 immunotherapy		2 years after immunotherapy initiation
Secondary	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
Secondary	Overall survival		5 years after immunotherapy initiation
Secondary	Progression free survival		6 months after immunotherapy initiation
Secondary	Progression free survival		1 year after immunotherapy initiation
Secondary	Progression free survival		2 years after immunotherapy initiation
Secondary	Progression free survival		3 years after immunotherapy initiation
Secondary	Duration of immunotherapy treatment	Treatment tolerability	Up to 7 years after immunotherapy initiation
Secondary	Reasons for treatment discontinuation		Up to 7 years after immunotherapy initiation
Secondary	Translational study of predictive biomarkers of efficacy		Up to 7 years after immunotherapy initiation