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| ID | Type | Description | Link |
|---|---|---|---|
| EU number | Other Identifier | 2024-A01300-47 |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohorte A: Immunothérapie sans chimiothérapie concomitante | Active Comparator | Immunotherapy without concurrent chemotherapy |
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| Cohorte B : Immunothérapie avec chimiothérapie concomitante | Active Comparator | Immunotherapy with concurrent chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Main objective of the study | Evaluate whether there is a correlation between T-cell function and radiological response under standard immunotherapy | up to 12 months |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armelle VINCENEUX, Dr | Contact | 04 26 55 68 33 | armelle.vinceneux@lyon.unicancer.fr |
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