Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment

Not Applicable

Recruiting

• Conditions: Immunotherapy; Immune Checkpoint Inhibitors; Predictive Biomarkers; Immune-related Adverse Event

• Registration Number: NCT05813418
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy.

Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-02
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• patient with cancer, whatever initial tumoral histology and disease stage under ICPI treatment (anti-PD1 and/or anti-CTLA-4)
• age > 18
• followed in oncology, pneumology, dermatology, gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital
• who received verbal and written information, and signed the consent form for the study

Exclusion Criteria

• non ICPI treated patients
• patient who received a first line of ICPI treatment
• patient who received or is receiving MEK inhibitors as a treatment (because of possible lower response to ICPI treatment when associated)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Variation from baseline of IL6 concentration in riAEs patients	6 months	Variation from baseline of IL6 concentration (pG/mL) in riAEs patients
Variation from baseline of IL10 concentration in riAEs patients	6 months	Variation from baseline of IL10 concentration (pG/mL) in riAEs patients
Variation from baseline of IL15 concentration in riAEs patients	6 months	Variation from baseline of IL15 concentration (pG/mL) in riAEs patients
Variation from baseline of MIP 1 alpha concentration in riAEs patients	6 months	Variation from baseline of MIP 1 alpha concentration (pG/mL) in riAEs patients
Variation from baseline of IL8 concentration in riAEs patients	6 months	Variation from baseline of IL8 concentration (pG/mL) in riAEs patients
Variation from baseline of INFgamma concentration in riAEs patients	6 months	Variation from baseline of INFgamma concentration (pG/mL) in riAEs patients
Variation from baseline of MCP-1 concentration in riAEs patients	6 months	Variation from baseline of MCP-1 concentration (pG/mL) in riAEs patients
Variation from baseline of sIL2R concentration in riAEs patients	6 months	Variation from baseline of sIL2R concentration (U/mL) in riAEs patients
Variation from baseline of sIL6R concentration in riAEs patients	6 months	Variation from baseline of sIL6R concentration (µG/mL) in riAEs patients
Variation from baseline of MIP 1 beta concentration in riAEs patients	6 months	Variation from baseline of MIP 1 beta concentration (pG/mL) in riAEs patients

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France