Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways

Cancer Clinical Trial

— MAB IN SITRO  

Official title:

Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04349293
• Other study ID #: 2016-A00732-49
• Secondary ID: 2015/2331
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2016
• Est. completion date: September 2021

Study information

• Verified date: April 2020
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Laurence ZITVOGEL, MD, PhD
• Phone: 0142114211
• Email: laurence.zitvogel[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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
• 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)

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, TNFa IFNg, IL-17 and IL-21).	Up yo one year