Immunotherapy in Upper Tract Urothelial Carcinoma

NCT ID: NCT06113367

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-02-28

Brief Summary

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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

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Conditions

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Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

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

Intervention Type OTHER

Non Applicable, research on data

Interventions

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

Non Applicable, research on data

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Clément Dumont, Dr

Role: CONTACT

+142494217

Jérôme Lambert, Pr

Role: CONTACT

+33142499742

Other Identifiers

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APHP230738

Identifier Type: -

Identifier Source: org_study_id

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