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

Sponsor
Institut Paoli-Calmettes (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03595813
Collaborator
Cancer Research Center of Marseille (Other)
135
Enrollment
1
Location
1
Arm
89
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood sample collection
  • Procedure: Biopsy collection
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy-IMMUNO-SUP-IPC 2017-002
Actual Study Start Date :
Jan 29, 2018
Actual Primary Completion Date :
Jul 17, 2020
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients treated with Immune Checkpoint Blockade

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

Procedure: Biopsy collection
Optional biopsy collection at baseline and progression

Outcome Measures

Primary Outcome Measures

  1. Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor [4 months]

    Measure (by flux cytometry) and comparison of plasma immunosuppressive actors, between baseline and the 4th injection of an Immune Checkpoint inhibitor

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Paoli-Calmettes Marseille Bouches-du-Rhône France

Sponsors and Collaborators

  • Institut Paoli-Calmettes
  • Cancer Research Center of Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT03595813
Other Study ID Numbers:
  • IMMUNO-SUP-IPC 2017-002
First Posted:
Jul 23, 2018
Last Update Posted:
Mar 29, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Paoli-Calmettes
Immune check point blockade
biomarkers
immunomonitoring
Additional relevant MeSH terms:
Neoplasms
Urologic Neoplasms

Study Results

No Results Posted as of Mar 29, 2021