An observational study in Cancer, Immune-related Adverse Event and Immune Checkpoint Inhibitor-Related Myocarditis, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 2 sites in France. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational
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.
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).
164 studies on the registry are indexed under Myocarditis; 71 are open to participants now.
This study's enrollment of 141,630 is above the median of 226 across 115 observational studies indexed under Myocarditis.
Browse Myocarditis studies →Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Any reports with an immune-related drug reaction attributed to an immune checkpoint inhibitor
Exclusion Criteria:
Reports of identified immune-related adverse event reaction
Drug: Immune checkpoint inhibitor
Reports associated with an an Immune checkpoint inhibitor with a status of "Suspect" or "Interacting" ICI will include the following list of FDA-apporved ICIs: nivolumab, pembrolizumab, cemiplimab, dostarlimab, durvalumab, atezolizumab, avelumab, ipilimumab, tremelimumab, relatlimab
Factors associated with an increased rate of fatality among reports with an immune-related adverse event (irAE).
Reports with a fatal outcome will be compared to reports with no fatal outcome. Odds ratio will be calculated to compare covariates potentially associated with an increase risk of fatality, including irAE type, cancer type reported, patient's age, gender, comorbidities, type of ICI or ICI combination and other treatments.
Time frame: any report prior to january 2023
Factors associated with an increased reporting of main irAE types
Main irAEs are identified through MedDRA terms declared. For each irAE and each risk factors, an odds ratio will be calculated to assess a potential over-reporting. Factors evaluated will include but will not be limited to: cancer type, anticancer treatment type, socio-demographic variables (gender, age, country of reporting etc ...), year of reporting among others.
Time frame: any report prior to january 2023
Time to onset for each irAE type
Time frame: any report prior to january 2023
Rate of relapse with treatment rechallenge
For each irAE, the rate (percentage) of irAE reccurence after treatment rechallenge.
Time frame: any report prior to january 2023
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier Pitie-Salpetriere