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

Condition(s) studied

Investigational drug(s) / intervention(s)

blood retriewal: blood retriewal for cytokine concentration measurement

Study 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

Primary outcome measure(s)

• 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

Trial sites (1)

More Centre Hospitalier Universitaire, Amiens trials in France

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