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NCT03595813 Clinical Trial

Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy

Non Hodgkin Lymphoma Clinical Trial

— IMMUNO-SUP  

Official title:
Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy-IMMUNO-SUP-IPC 2017-002

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03595813
Other study ID # IMMUNO-SUP-IPC 2017-002
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 29, 2018
Est. completion date July 2025

Study information
Verified date March 2021
Source Institut Paoli-Calmettes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The development of Immune Checkpoint Blockade (ICB) is a revolution in medical oncology as ICB have changed the standard treatments of several metastatic tumor types. However, the response rate to ICB is low, and the biological bases for this response heterogeneity are poorly understood. In the frame of Immunosup study, we will collect blood (at baseline, post infusion of ICB n°2/4/8 and at progression) and tumor samples (optional: at baseline and progression) from patients with locally advanced or metastatic cancer, treated with ICB, in order to determine if the dynamics of immunosuppressive actors (MDSC, TReg, Immunosuppressive cytokines) predicts response to these immunotherapies.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 135
Est. completion date July 2025
Est. primary completion date July 17, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years - Diagnosis of locally advanced or metastatic solid tumor or lymphoma treated with Immune check blockade - Signed informed consent - Affiliated to(or beneficiary of) the French Social Security Exclusion Criteria: - Pregnant or breastfeeding woman or woman who does not apply effective contraception - Emergency - Vulnerable person or unable to provide informed consent - Emergency - Person unable to comply with required study follow up - Contraindication to the study procedure

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sample collection
Blood samples collection (5EDTA vials) at baseline, post infusion of ICB n°2/4/8 and at progression
• Biopsy collection
Optional biopsy collection at baseline and progression

Locations
Country Name City State
France Institut Paoli-Calmettes Marseille Bouches-du-Rhône

Sponsors (2)
Lead Sponsor Collaborator
Institut Paoli-Calmettes Cancer Research Center of Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor Measure (by flux cytometry) and comparison of plasma immunosuppressive actors, between baseline and the 4th injection of an Immune Checkpoint inhibitor 4 months
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