eligibility_summary
Eligible reports must involve an FDA-approved immune checkpoint inhibitor (ICI) listed as Suspect or Interacting for the adverse event. Exclude reports if the ICI is not FDA-approved or if no immune-related adverse event (irAE) is identified.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Observational pharmacovigilance study using VigiBase to characterize immune-related adverse events (irAEs) from FDA-approved immune checkpoint inhibitors (ICIs). Interventions: monoclonal antibodies blocking PD-1 (nivolumab, pembrolizumab, cemiplimab, dostarlimab), PD-L1 (durvalumab, atezolizumab, avelumab), CTLA-4 (ipilimumab, tremelimumab), and LAG-3 (relatlimab). Mechanism: checkpoint blockade removes inhibitory signaling to enhance antitumor T-cell activation and effector function. Targets/pathways: PD-1/PD-L1 axis in the tumor microenvironment, CTLA-4–B7 pathway during T-cell priming, and LAG-3 on exhausted/regulatory T cells. Primary cells affected: CD8+ and CD4+ T lymphocytes and antigen-presenting cells, effects include increased cytokine production and loss of peripheral tolerance leading to irAEs (e.g., myocarditis). The study maps time-to-onset, co-occurrence, and fatality patterns.