Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events

Cancer Clinical Trial

— 19-916  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04169503
• Other study ID #: Pharmaco15-19-07
• Status: Recruiting
• Start date: October 14, 2019
• Est. completion date: February 2020

Study information

• Verified date: July 2019
• Source: University Hospital, Caen
• Contact: Joachim Alexandre, MD
• Phone: +33231064670
• Email: alexandre-j[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17562
• Est. completion date: February 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Alexandre Joachim	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)..
Secondary	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)..
Secondary	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)..