Immunotherapy in Upper Tract Urothelial Carcinoma (VESUVIO)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Urothelial Carcinoma

Treatments: Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy

Study type: Observational

Funder types: Other

Identifiers

NCT06113367

APHP230738

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

350 participants in 1 patient group

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

Treatment:

Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy