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

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer Metastatic; Non Hodgkin Lymphoma; Urologic Neoplasms; Locally Advanced Malignant Neoplasm
• Interventions: Procedure: Blood sample collection; Procedure: Biopsy collection

• Registration Number: NCT03595813
• Lead Sponsor: Institut Paoli-Calmettes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-29
• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-23
• Primary Completion: 2020-07-17
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-03-29
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients treated with Immune Checkpoint Blockade	Biopsy collection	-
Patients treated with Immune Checkpoint Blockade	Blood sample collection	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, Bouches-du-Rhône, France