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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
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 11, 2018
Last Updated
March 26, 2021
Sponsor
Institut Paoli-Calmettes
Collaborators
Cancer Research Center of Marseille
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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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