Immunotherapy in Upper Tract Urothelial Carcinoma | NCT06113367

Studies
Immunotherapy in Upper Tract Urothelial Carcinoma

NCT06113367

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Nov 2, 2023Actual

Enrollment

350Estimated

Phase

Not provided

Conditions

Urothelial Carcinoma

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Estimated

Primary Completion Date

Feb 28, 2024Estimated

Completion Date

Feb 28, 2024Estimated

First Submitted Date

Oct 27, 2023

First Submission Date that Met QC Criteria

Oct 27, 2023

First Posted Date

Nov 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2023

Last Update Posted Date

Nov 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy			Other: Evaluation of anti-PD-(L)1 immunotherapy efficacy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evaluation of anti-PD-(L)1 immunotherapy efficacy	Other	Non Applicable, research on data	Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival on anti-PD-(L)1 immunotherapy		2 years after immunotherapy initiation

Secondary Outcomes

Measure	Description	Time Frame
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
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clément Dumont, Dr	Contact	+142494217		clement.dumont@aphp.fr
Jérôme Lambert, Pr	Contact	+33142499742		jerome.lambert@u-paris.fr

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002295	Carcinoma, Transitional Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided