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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04886401
Other study ID # PREDICTION - 29BRC21.0115
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 16, 2021
Est. completion date May 16, 2021

Study information

Verified date April 2021
Source University Hospital, Brest
Contact Margaux GEIER, MD
Phone 02 30 33 80 30
Email margaux.geier@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Therapeutic antibodies that block the programmed death-ligand 1 (PD-L1)/programmed death-1 (PD-1) pathway have revolutionized immuno-oncology by inducing robust and durable responses in patients with various cancer including advanced non-small-cell lung cancer (NSCLC). However, these responses only occur in a subset of patients, even in case of PD-L1 overexpression. Elucidating the determinants of response and resistance but also of severe immune-mediated adverse events is key to improving outcomes and developing new treatment strategies. Biomarkers that predict immune checkpoint inhibitors efficacy and toxicity are urgently needed and could emerge from characterization of tumor microenvironment. The purpose of PREDICTION project is to elucidate response and toxicity predictive immunophenotypic signatures using a new in situ multiplexed strategy with imaging mass cytometry Hyperion. Patients treated with anti-PD-1 pembrolizumab will be selected on their response and toxicity profiles. Then, tumor samples will be analysed with Hyperion technology, allowing delineation of cell subpopulations and cell-cell interactions, highlighting tumor heterogeneity and to determine correlations between response and toxicity features. The number of co-analysable markers enables global vision on the same tissue section. A better understanding of the tumor microenvironment complex system will lead to discover new predictive biomarkers potentially transferable to current practice.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 16, 2021
Est. primary completion date May 16, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Adult patients - Advanced NSCLC with PD-L1 TPS of 50% or greater - Administration of first line pembrolizumab between January 2017 & December 2019 Exclusion Criteria: - Auto-immune disease - Prior exposure to immunotherapy - First dose pembrolizumab administered after December 2019

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identifying predictive biomarkers of anti-PD-1 response Identifying predictive biomarkers of anti-PD-1 response by highlighting discriminant cell profiles between responder and non-responder patients 1 year
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