Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events

NCT04169503 | Unknown FDA Drug

• 1 other identifier: Pharmaco15-19-07
• Study Type: observational
• Target: 17,562
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)..

Interventions

Immune Checkpoint Modulator DRUG

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with immune checkpoint inhibitors and experiencing irAEs

You may qualify if:

• 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.

You may not qualify if:

• Chronology not compatible between the drug and the toxicity.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Alexandre Joachim

Caen, Basse Normandie, 14000, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Joachim Alexandre, MD

CONTACT

+33231064670; alexandre-j@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: November 20, 2019
• Study Start: October 14, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: November 20, 2019

Record last verified: 2019-07

Locations

FR (1)