Clinical trial · Interventional
Lymphocyte Function Testing in Immuno-oncology
Prospective, Single-center, Clinico-biological Cohort Evaluating the Automated VIDAS STIMM T Test in Patients With Advanced/Metastatic Solid Tumors Treated With Standard Immunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor Malignancies | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cohorte A: Immunothérapie sans chimiothérapie concomitante
- description
- Immunotherapy without concurrent chemotherapy
- interventionNames
- Diagnostic Test: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO
- type
- ACTIVE_COMPARATOR
- label
- Cohorte B : Immunothérapie avec chimiothérapie concomitante
- description
- Immunotherapy with concurrent chemotherapy
- interventionNames
- Diagnostic Test: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO
Primary outcomes (1)
- measure
- Main objective of the study
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available