Lymphocyte Function Testing in Immuno-oncology

Not Applicable

Not yet recruiting

• Conditions: Immunotherapy; Advanced Solid Tumor Malignancies

• Registration Number: NCT07155811
• Lead Sponsor: Centre Leon Berard

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Study Start: 2025-09-23
• Primary Completion: 2025-09-23
• Study Completion: 2025-09-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Main objective of the study	up to 12 months	Evaluate whether there is a correlation between T-cell function and radiological response under standard immunotherapy