Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy
IMMUNO-SUP
1 other identifier
interventional
135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2018
CompletedFirst Submitted
Initial submission to the registry
July 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2025
CompletedApril 21, 2026
April 1, 2026
2.5 years
July 11, 2018
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Patients treated with Immune Checkpoint Blockade
EXPERIMENTALInterventions
Blood samples collection (5EDTA vials) at baseline, post infusion of ICB n°2/4/8 and at progression
Optional biopsy collection at baseline and progression
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Paoli-Calmetteslead
- Cancer Research Center of Marseillecollaborator
Study Sites (1)
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, France
Related Publications (1)
Rochigneux P, Lisberg A, Garcia A, Granjeaud S, Madroszyk A, Fattori S, Goncalves A, Devillier R, Maby P, Salem N, Gorvel L, Chanez B, Gukasyan J, Carroll J, Goldman J, Chretien AS, Olive D, Garon EB. Mass Cytometry Reveals Classical Monocytes, NK Cells, and ICOS+ CD4+ T Cells Associated with Pembrolizumab Efficacy in Patients with Lung Cancer. Clin Cancer Res. 2022 Dec 1;28(23):5136-5148. doi: 10.1158/1078-0432.CCR-22-1386.
PMID: 36166003RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2018
First Posted
July 23, 2018
Study Start
January 29, 2018
Primary Completion
July 17, 2020
Study Completion
June 25, 2025
Last Updated
April 21, 2026
Record last verified: 2026-04