Clinical trial NCT05934214: EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance Database
Official title: Immune-related Adverse Events From Immune Checkpoint Inhibitor Characterization Using VigiBase, the WHO Pharmacovigilance Database: An Exploration of Adverse Event Patterns and Signal Detection.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Immune-related Adverse Event
Immune Checkpoint Inhibitor-Related Myocarditis
Keywords: Immune checkpoint inhibitors
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Institut Curie
First posted: 2023-07-06
Enrollment: 141630
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any reports with an immune-related drug reaction attributed to an immune checkpoint inhibitor

Brief summary: This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database.

This study includes all reports identified as exposure to an ICI and suspect of inducing adverse drug reaction.

The aim of the study is to characterize immune-related adverse reactions associated with immune-checkpoint inhibitors, particularly their time-to-onset, co-occurence, factors associate with their over-report and fatality.

Detailed description: Over the past ten years, immuno-oncology (IO) has gradually integrated the therapeutic arsenal of cancer treatment. CTLA-4, program-death 1 (PD1) and its ligand (PD-L1) and LAG3 were found to be major targets active in multiple tumor types. Immune checkpoint inhibitors (ICI) are antibodies blocking these targets and became a cornestone of cancer treatment.

This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database. VigiBase is managed by the Uppsala Monitoring Centre (UMC, Uppsala, Sweden) and contains about 30 million reports (as of Jan 2023) submitted by national pharmacovigilance centers since 1967.

The use of VigiBase® for pharmacovigilance analyses is not dependent on institutional review board approval. It is conditioned on institutional access provided and approved by the Uppsala Monitoring Centre. Since spontaneous reporting systems are based on anonymity and the process only requires patient non-opposition, no informed consent was requested to use VigiBase® in this study.

This study includes all reports associated with an ICI. The query is performed using the Medical Dictionary for Regulatory Activities (MedDRA), between January 1st 2008 (year of first report of ICI in VigiBase), and January 1st 2023. The analysis focused on reports suspected to be induced by an ICI (as opposed to concurrent use).

Eligibility criteria: Inclusion Criteria:

* Any report with an ICI "Suspect" or "Interacting" with the reported adverse drug reaction.

Exclusion Criteria:

* ICI not FDA approved
* No irAE identified in report

Primary outcomes:
measure: Factors associated with an increased rate of fatality among reports with an immune-related adverse event (irAE).
timeFrame: any report prior to january 2023
Secondary outcomes:
measure: Factors associated with an increased reporting of main irAE types
timeFrame: any report prior to january 2023
measure: Time to onset for each irAE type
timeFrame: any report prior to january 2023
measure: Rate of relapse with treatment rechallenge
timeFrame: any report prior to january 2023
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
city: Paris
country: France
facility: CIC Paris-Est / Institut Curie
Study officials:
References: