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NCT Number: NCT03595813

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

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.

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Key information

Conditions

Lung Cancer Metastatic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Locally Advanced Malignant Neoplasm Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Non Hodgkin Lymphoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Paoli-Calmettes

Marseille, Bouches-du-Rhône, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample collection

Procedure

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

Biopsy Collection

Procedure

Optional biopsy collection at baseline and progression

Primary outcomes

  1. Evaluation of Plasma immunosuppressive actors in patients treated with a Checkpoint inhibitor

    Time frame: 4 months

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

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Collaborators

  • Cancer Research Center of Marseille

Registry information

Official study title

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

Acronym: IMMUNO-SUP

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Jul 23, 2018
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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