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

NCT05813418 | Recruiting

• 1 other identifier: PI2019_843_0078
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (10)

• Variation from baseline of IL6 concentration in riAEs patients

  Variation from baseline of IL6 concentration (pG/mL) in riAEs patients

  6 months

• Variation from baseline of IL10 concentration in riAEs patients

  Variation from baseline of IL10 concentration (pG/mL) in riAEs patients

  6 months

• Variation from baseline of IL15 concentration in riAEs patients

  Variation from baseline of IL15 concentration (pG/mL) in riAEs patients

  6 months

• Variation from baseline of IL8 concentration in riAEs patients

  Variation from baseline of IL8 concentration (pG/mL) in riAEs patients

  6 months

• Variation from baseline of INFgamma concentration in riAEs patients

  Variation from baseline of INFgamma concentration (pG/mL) in riAEs patients

  6 months

• Variation from baseline of MCP-1 concentration in riAEs patients

  Variation from baseline of MCP-1 concentration (pG/mL) in riAEs patients

  6 months

• 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

• 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

• Variation from baseline of sIL2R concentration in riAEs patients

  Variation from baseline of sIL2R concentration (U/mL) in riAEs patients

  6 months

• Variation from baseline of sIL6R concentration in riAEs patients

  Variation from baseline of sIL6R concentration (µG/mL) in riAEs patients

  6 months

Interventions

blood retriewal BIOLOGICAL

blood retriewal for cytokine concentration measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Central Hospital Saint Quentin: collaborator

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

Central Study Contacts

Gwladys BOURDENET, DR

CONTACT

03.22.08.70.72; bourdenet.gwladys@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: July 2, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)