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

NCT ID: NCT03595813

Last Updated: 2021-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-29

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Lung Cancer Metastatic Locally Advanced Malignant Neoplasm Non Hodgkin Lymphoma Urologic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients treated with Immune Checkpoint Blockade

Group Type EXPERIMENTAL

Blood sample collection

Intervention Type PROCEDURE

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

Biopsy collection

Intervention Type PROCEDURE

Optional biopsy collection at baseline and progression

Interventions

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Blood sample collection

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

Intervention Type PROCEDURE

Biopsy collection

Optional biopsy collection at baseline and progression

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research Center of Marseille

OTHER

Sponsor Role collaborator

Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Paoli-Calmettes

Marseille, Bouches-du-Rhône, France

Site Status

Countries

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France

Other Identifiers

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IMMUNO-SUP-IPC 2017-002

Identifier Type: -

Identifier Source: org_study_id

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