Lymphocyte Function Testing in Immuno-oncology

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.

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Key information

Conditions

Immunotherapy Advanced Solid Tumor Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO

Diagnostic Test

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 (immunofluorescence technique) to quantify the concentrations of IFN-γ in the supernatant of each sample. The entire process is automated, and results are obtained within 4 hours.

Primary outcomes

Main objective of the study

Time frame: up to 12 months

Evaluate whether there is a correlation between T-cell function and radiological response under standard immunotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Armelle VINCENEUX, Dr

CONTACT

[email protected]

04 26 55 68 33

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study 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

Acronym: T-ECHNICO

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Sep 4, 2025
Registry last updated: Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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