Immunotherapy in Upper Tract Urothelial Carcinoma

Not yet recruiting

• Conditions: Urothelial Carcinoma
• Interventions: Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy

• Registration Number: NCT06113367
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study Start: 2023-11-01
• Study First Posted: 2023-11-02
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy	Evaluation of anti-PD-(L)1 immunotherapy efficacy	-

Primary Outcome Measures

Name	Time	Method
Overall survival on anti-PD-(L)1 immunotherapy	2 years after immunotherapy initiation

Secondary Outcome Measures

Name	Time	Method
Translational study of predictive biomarkers of efficacy	Up to 7 years after immunotherapy initiation
Reasons for treatment discontinuation	Up to 7 years after immunotherapy initiation
Overall survival	5 years after immunotherapy initiation
Progression free survival	3 years after immunotherapy initiation
Best Objective Radiologic Response	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.
Duration of immunotherapy treatment	Up to 7 years after immunotherapy initiation	Treatment tolerability