Lymphocyte Function Testing in Immuno-oncology
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged 18 years or older with a confirmed diagnosis of solid tumors (any type of tumor) in advanced or metastatic stages
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO
Diagnostic testThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Cohorte A: Immunothérapie sans chimiothérapie concomitanteActive comparator 1 intervention
Group B: Cohorte B : Immunothérapie avec chimiothérapie concomitanteActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Main objective of the study
Evaluate whether there is a correlation between T-cell function and radiological response under standard immunotherapy
Time frame
up to 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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