Lymphocyte Function Testing in Immuno-oncology

Official title

Prospective, Single-center, Clinico-biological Cohort Evaluating the Automated VIDAS STIMM T Test in Patients With Advanced/Metastatic Solid Tumors Treated With Standard Immunotherapy

Overview

Several studies have shown that the presence and levels of IFN-γ may correlate with better responses to immunotherapy. Higher baseline levels of IFN-γ and an increase in its production during treatment have been associated with better clinical outcomes in patients receiving immunotherapy such as anti-PD-1/PD-L1 or anti-CTLA4. To date, there is no simple, rapid, automated, and standardized test to assess T-cell functionality and quantify the level of immunosuppression in individual patients. To address this medical need, bioMérieux has developed the VIDAS® STIMM™ T RUO automated functional immune test, which can determine a patient's immune status by measuring IFN-γ production by T lymphocytes after stimulation by a mitogen in approximately four hours without human intervention. The aim of this study is to evaluate whether the amount of IFN-γ produced by T lymphocytes, as measured by an automated VIDAS® STIMM™ T functional immune test, correlates with disease progression in patients with advanced/metastatic solid tumors treated with standard immunotherapy.

Interventions

• Diagnostic test test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO
  The functional assessment of T lymphocytes is based on the use of the VIDAS® STIMM™ T RUO test, which will be performed on freshly collected whole blood in lithium heparin tubes without gel separators. Blood samples will be sent to the Immunology Laboratory at E. Herriot Hospital (Prof. Guillaume Monneret). T lymphocytes will be stimulated ex vivo for 3.5 hours (non-antigen-dependent stimulation by PHA) on the VIDAS®3 automated system (bioMérieux). The automated system then performs a assay (im

Primary outcome measures

• Main objective of the study [Time frame: up to 12 months]

Eligibility criteria

Inclusion criteria

• Male or female aged 18 years or older with a confirmed diagnosis of solid tumors (any type of tumor) in advanced or metastatic stages
• Patients who are due to start standard treatment with anti-PD1, anti-PDL1, or anti-CTLA4 (combinations of ICIs are permitted) at the Léon Bérard Center:

• Cohort A: ICI without concomitant chemotherapy
• Cohort B: ICI with concomitant chemotherapy
• Patients who have understood, dated, and signed the consent form for this study before undergoing any protocol-specific procedures.
• Patients affiliated with or covered by a social security system.

Exclusion criteria

• Patients to be treated with immunotherapy in combination with targeted therapy.
• Patients treated with chemotherapy within the last 21 days prior to D1 of immunotherapy
• Pregnant or breastfeeding patients.
• Patients with other known cancers that are progressing or requiring the initiation of another treatment.
• Patients with psychological, family, geographical, or social circumstances that, in the investigator's judgment, could potentially prevent the signing of an informed consent form and/or compliance with study procedures.
• Patients in one or more of the following situations: subject to legal protection measures, deprived of liberty by judicial or administrative decision, receiving psychiatric care, admitted to a health or social care facility for purposes other than research

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07155811 · ET24-155 T-ECHNICO · EU number

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗