Immunotherapy in Upper Tract Urothelial Carcinoma

Trial Title: Immunotherapy in Upper Tract Urothelial Carcinoma

NCT ID: NCT06113367

Condition: Urothelial Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Immunomodulating Agents

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Other
Intervention name: Evaluation of anti-PD-(L)1 immunotherapy efficacy
Description: Non Applicable, research on data
Arm group label: Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Start date: November 1, 2023

Completion date: February 28, 2024

Lead sponsor:
Agency: Assistance Publique - Hôpitaux de Paris
Agency class: Other

Source: Assistance Publique - Hôpitaux de Paris

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06113367