Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events (19-916)

Caen University Hospital

Status: Unknown

Conditions: Cancer

Treatments: Drug: Immune Checkpoint Modulator

Study type: Observational

Funder types: Other

Identifiers

NCT04169503

Pharmaco15-19-07

Details and patient eligibility

About

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

Enrollment: 17,562 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.