Immunological adverse effects of immune checkpoint inhibitors (ICIMMUN)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104677
• EU PAS number:
  EUPAS104661
• Study ID:
  104677
• Official title and acronym:
  Immunological adverse effects of immune checkpoint inhibitors (ICIMMUN)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  A) Immune checkpoint inhibitors (ICI) are a recent type of cancer treatment that enhances the immune response against cancer cells. They have received marketing authorisation in various cancers, with a first administration in post-autorisation marketing in France in 2012. There is a growing concern about the occurrence of immune-related adverse events (irAE) related to these treatments with an increase in the number of alerts from case reports or pharmacovigilance databases.The main aim of this study is to assess the incidence rate of severe irAE globally and by type of irAE, by type of ICI and combination of ICI, in real use in France. Secondary aims are:. B) To Assess the incidence rate of severe irAE globally and by type of irAE, by type of ICI and combination of ICI, and this by type of cancer (for cancers for which sufficient numbers of patients will be treated) C) To describe how ICI are used (characteristics of patients treated, type of ICI, combinations, successive treatments, associated treatments, depending on the type of cancer for which the number of patients treated will be sufficient) D) To describe the therapeutic management of irAE (treatment including immunosuppressants, hospitalization in resuscitation, total duration of hospitalization, associated costs, survival) E) To assess the mortality rate in patients who have developed severe irAE under ICI F) To identify risk factors for the occurrence of irAE These objectives will be also addressed in some specific subpopulations of interest. This project will provide a global overview of short and long-term irAE of ICI observed in real life conditions and to search for their risk factors, thus allowing an optimization of the management of patients.
• Study status:
  Planned

Research institution and networks

Institutions

Assistance Publique - Hôpitaux de Paris (AP-HP)

France

Study timelines

Date when funding contract was signed

Actual: 13/01/2021

Study start date

Planned: 15/03/2019

Data analysis start date

Actual: 01/08/2021

Date of final study report

Planned: 31/12/2025

Sources of funding

Other

More details on funding

BMS Fondation

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable