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

University Hospital, Caen1 site in 1 country17,562 target enrollmentOctober 14, 2019

ConditionsCancer

DrugsImmune Checkpoint Modulator

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: University Hospital, Caen
Enrollment: 17562
Locations: 1
Primary Endpoint: Rate of occurrence of second immune-related adverse events (irAEs)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 14, 2019

End Date

February 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Caen

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Rate of occurrence of second immune-related adverse events (irAEs)

Time Frame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).

percentage of cases experiencing a second irAE among the rechallenged cases

Secondary Outcomes

Description 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(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(Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..)