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

Immunotherapy Clinical Trial

— Ibe2i-TIPCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813418
• Other study ID #: PI2019_843_0078
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2021
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Gwladys BOURDENET, DR
• Phone: 03.22.08.70.72
• Email: bourdenet.gwladys[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Immune Checkpoint Inhibitors
• Immune-related Adverse Event
• Immunotherapy
• Predictive Biomarkers

Intervention

Biological:
• blood retriewal
blood retriewal for cytokine concentration measurement

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Central Hospital Saint Quentin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation from baseline of IL6 concentration in riAEs patients	Variation from baseline of IL6 concentration (pG/mL) in riAEs patients	6 months
Primary	Variation from baseline of IL10 concentration in riAEs patients	Variation from baseline of IL10 concentration (pG/mL) in riAEs patients	6 months
Primary	Variation from baseline of IL15 concentration in riAEs patients	Variation from baseline of IL15 concentration (pG/mL) in riAEs patients	6 months
Primary	Variation from baseline of IL8 concentration in riAEs patients	Variation from baseline of IL8 concentration (pG/mL) in riAEs patients	6 months
Primary	Variation from baseline of INFgamma concentration in riAEs patients	Variation from baseline of INFgamma concentration (pG/mL) in riAEs patients	6 months
Primary	Variation from baseline of MCP-1 concentration in riAEs patients	Variation from baseline of MCP-1 concentration (pG/mL) in riAEs patients	6 months
Primary	Variation from baseline of MIP 1 alpha concentration in riAEs patients	Variation from baseline of MIP 1 alpha concentration (pG/mL) in riAEs patients	6 months
Primary	Variation from baseline of MIP 1 beta concentration in riAEs patients	Variation from baseline of MIP 1 beta concentration (pG/mL) in riAEs patients	6 months
Primary	Variation from baseline of sIL2R concentration in riAEs patients	Variation from baseline of sIL2R concentration (U/mL) in riAEs patients	6 months
Primary	Variation from baseline of sIL6R concentration in riAEs patients	Variation from baseline of sIL6R concentration (µG/mL) in riAEs patients	6 months