Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events

• Conditions: Cancer

• Registration Number: NCT04169503
• Lead Sponsor: University Hospital, Caen

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-19
• Study Start: 2019-10-14
• Study First Submitted QC: 2019-11-17
• Last Update Submitted: 2019-11-17
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20
• Primary Completion: 2020-01
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17562

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of occurrence of second immune-related adverse events (irAEs)	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 Outcome Measures

Name	Time	Method
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 clinical features of cases experiencing an initial irAEs
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 clinical features of the rechallenged cases
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)..	Description of the clinical features of cases experiencing a second irAEs

Trial Locations

Locations (1)

Alexandre Joachim; 🇫🇷 Caen, Basse Normandie, France