Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways (MAB IN SITRO)

Multicentric interventional prospective study with collection of biological samples as part of a routine care research

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Procedure: Tissue sampling; Procedure: Blood sampling

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94800
      • Recruiting
      • Gustave Roussy
      • Contact: Agathe DUBUISSON, PhD; Phone Number: +33 0142114211; Email: agathe.dubuisson@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age greater than or equal to 18 years.
2. Male and female sex.
3. Any patient with cancer (see list in the body of the protocol) requiring treatment by surgical resection and / or who will start treatment with mAb or BiTE.
4. Patient information and signed informed consent.
5. Subjects affiliated (or beneficiary) to a social security scheme

Patients treated for immune complications by immunosuppressants may be included (corticosteroids, etc.).

Exclusion Criteria:

1. History of severe systemic autoimmune disease.
2. Pregnant or breastfeeding patient
3. Impossibility or refusal to sign informed consent
4. Patient under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with cancer	Procedure: Tissue sampling; Collection of a sample of tumor tissue and a sample of adjacent or counter lateral healthy tissue (if possible) from the surgical room; Procedure: Blood sampling; Collection of a 30mL peripheral blood sample in heparin at several times: during surgical and medical treatment (before surgery, before the start of mAbs and after mAbs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunophenotyping of immune infiltrates by flow cytometry	Immunophenotyping analysis by flow cytometry (Cyan, Beckman Coulter): identification of several immune sub-populations (T-B-NK lymphocytes, myeloid and tumor cells); identifications of several receptors and ligands (PD1 / PDL1, Tim-3 / HAVCR2,, CTLA-4, 4-1BB / 4-1BBL, Fas / FasL, TRAIL, OX40 / OX40L, ICOS / ICOSL, CD69, CD25 / CD127, NKp46 / NKp30, NKG2D / NKG2DL, galectin-9, MHC class I and II, B7H3 / B7H6); identification of memory subpopulations (CD45RA / CD27 / CCR7) and, if available, intra-cytoplasmic labeling (CXCR3, CCR6, Granzyme B, KI67, TNFα IFNg, IL-17 and IL-21).	Up yo one year

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2016
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016-A00732-49; 2015/2331 (Other Identifier: CSET number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No