Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events

Study Overview
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Brief Summary
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Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE. Our objective was to investigate the safety of ICI rechallenge after an irAE using the WHO pharmacovigilance database

Official Title
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Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events in Patients With Cancer: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database

Conditions
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Cancer

Intervention / Treatment
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* Drug: Immune Checkpoint Modulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction, consecutive individual case safety reports present in VigiBase reporting an irAEs associated to at least one immune checkpoint inhibitor. Exclusion Criteria: Chronology not compatible between the drug and the toxicity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Immune Checkpoint Modulator|identification of cases of immune-related adverse events due to immune checkpoint inhibitors. Among these cases, identification and description of those with immune checkpoint inhibitor rechallenge.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of occurrence of second immune-related adverse events (irAEs) | percentage of cases experiencing a second irAE among the rechallenged cases | Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of cases experiencing an initial irAEs | description of clinical features of cases experiencing an initial irAEs | Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).. | 
| Description of the rechallenge cases | description of clinical features of the rechallenged cases | Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).. | 
| Description of the clinical features of cases experiencing a second irAEs | Description of the clinical features of cases experiencing a second irAEs | Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).. |