Immunological adverse effects of immune checkpoint inhibitors (ICIMMUN)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX04) ipilimumab

  ipilimumab

  (L01FF01) nivolumab

  nivolumab

  (L01FF02) pembrolizumab

  pembrolizumab

  (L01FF03) durvalumab

  durvalumab

  (L01FF04) avelumab

  avelumab

  (L01FF05) atezolizumab

  atezolizumab

  (L01FF06) cemiplimab

  cemiplimab

  (L01FF07) dostarlimab

  dostarlimab
• Medical condition to be studied:
  Neoplasm malignant
• Additional medical condition(s):
  Immune-mediated adverse reaction

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  130000

Study design details

• Main study objective:
  To Evaluate the incidence rate of severe irAE globally and by type of irAE, by type of ICI and combination of ICI, in a real situation of use in France. in real life setting in France.
• Outcomes:
  Time to severe immune-mediated adverse event, Time to death
• Data analysis plan:
  In general, for the descriptions that will be conducted in relation to the different objectives, the characteristics of the population will be described in terms of mean and standard deviation or median and interquartile range (IQR) for quantitative variables. Quantitative variables will be described in terms of mean and standard deviation or median and inter-quartile range (IQR). Qualitative data will be described in terms of frequency and proportion. The cumulative incidence curves (to account for competition with death) of irAE will be estimated by the Gray method. The effect of risk factors on the occurrence of irAE will be estimated with a Fine and Gray model.