Ibe2i-TIPCI: Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05813418

Collaborator

Central Hospital Saint Quentin (Other)

150

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immunotherapy Immune Checkpoint Inhibitors Immune-related Adverse Event Predictive Biomarkers Plasmatic Cytokines Circulating Immune Subpopulations	Biological: blood retriewal	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients

Actual Study Start Date :

Jul 2, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Outcome Measures

Primary Outcome Measures

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 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 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 MIP 1 beta concentration in riAEs patients [6 months]
Variation from baseline of MIP 1 beta 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)