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.

NCT Number	NCT07155811
Lead Sponsor	Centre Leon Berard
Conditions	Immunotherapy, Advanced Solid Tumor Malignancies
Enrollment	100 participants
Start Date	2025-09-23
Primary Completion	2025-09-23 (estimated)
Study Completion	2025-09-23 (estimated)
Updated on ClinicalTrials.gov	2025-09-04