Lymphocyte Function Testing in Immuno-oncology (T-ECHNICO)

Léon Bérard Center

Status: Not yet enrolling

Conditions: Advanced Solid Tumor Malignancies; Immunotherapy

Treatments: Diagnostic Test: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO

Study type: Interventional

Funder types: Other

Identifiers

NCT07155811

EU number (Other Identifier)

ET24-155 T-ECHNICO

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Cohorte A: Immunothérapie sans chimiothérapie concomitante

Active Comparator group

Description:

Immunotherapy without concurrent chemotherapy

Treatment:

Diagnostic Test: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO

Cohorte B : Immunothérapie avec chimiothérapie concomitante

Active Comparator group

Description:

Immunotherapy with concurrent chemotherapy

Treatment:

Diagnostic Test: test immunitaire fonctionnel automatisé VIDAS® STIMM™ T RUO