Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy (IMMUNO-SUP)
Primary Purpose
Lung Cancer Metastatic, Locally Advanced Malignant Neoplasm, Non Hodgkin Lymphoma
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample collection
Biopsy collection
Sponsored by
About this trial
This is an interventional basic science trial for Lung Cancer Metastatic focused on measuring Immune check point blockade, biomarkers, immunomonitoring
Eligibility Criteria
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
Sites / Locations
- Institut Paoli-Calmettes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients treated with Immune Checkpoint Blockade
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03595813
First Posted
July 11, 2018
Last Updated
March 26, 2021
Sponsor
Institut Paoli-Calmettes
Collaborators
Cancer Research Center of Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03595813
Brief Title
Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy
Acronym
IMMUNO-SUP
Official Title
Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy-IMMUNO-SUP-IPC 2017-002
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
July 17, 2020 (Actual)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
Cancer Research Center of Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Metastatic, Locally Advanced Malignant Neoplasm, Non Hodgkin Lymphoma, Urologic Neoplasms
Keywords
Immune check point blockade, biomarkers, immunomonitoring
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients treated with Immune Checkpoint Blockade
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Blood sample collection
Intervention Description
Blood samples collection (5EDTA vials) at baseline, post infusion of ICB n°2/4/8 and at progression
Intervention Type
Procedure
Intervention Name(s)
Biopsy collection
Intervention Description
Optional biopsy collection at baseline and progression
Primary Outcome Measure Information:
Title
Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor
Description
Measure (by flux cytometry) and comparison of plasma immunosuppressive actors, between baseline and the 4th injection of an Immune Checkpoint inhibitor
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institut Paoli-Calmettes
City
Marseille
State/Province
Bouches-du-Rhône
Country
France
12. IPD Sharing Statement
Learn more about this trial
Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy
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