Clinical trial NCT05813418: Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment
Official title: Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immunotherapy
Immune Checkpoint Inhibitors
Immune-related Adverse Event
Predictive Biomarkers
Keywords: immunotherapy
immune checkpoint inhibitors
Immune-related Adverse Event
predictive biomarkers
plasmatic cytokines
circulating immune subpopulations
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Central Hospital Saint Quentin
First posted: 2023-04-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Variation from baseline of IL6 concentration in riAEs patients
timeFrame: 6 months
measure: Variation from baseline of IL10 concentration in riAEs patients
timeFrame: 6 months
measure: Variation from baseline of IL15 concentration in riAEs patients
timeFrame: 6 months
measure: Variation from baseline of IL8 concentration in riAEs patients
timeFrame: 6 months
measure: Variation from baseline of INFgamma concentration in riAEs patients
timeFrame: 6 months
measure: Variation from baseline of MCP-1 concentration in riAEs patients
timeFrame: 6 months
measure: Variation from baseline of MIP 1 alpha concentration in riAEs patients
timeFrame: 6 months
measure: Variation from baseline of MIP 1 beta concentration in riAEs patients
timeFrame: 6 months
measure: Variation from baseline of sIL2R concentration in riAEs patients
timeFrame: 6 months
measure: Variation from baseline of sIL6R concentration in riAEs patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References: