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19-916: Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events

Sponsor
University Hospital, Caen (Other)
Overall Status
Unknown status
CT.gov ID
NCT04169503
Collaborator
(none)
17,562
Enrollment
1
Location
3.6
Anticipated Duration (Months)
4859.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Immune Checkpoint Modulator

Study Design

Study Type:
Observational
Anticipated Enrollment :
17562 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
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
Actual Study Start Date :
Oct 14, 2019
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Feb 1, 2020

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alexandre Joachim Caen Basse Normandie France 14000

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT04169503
Other Study ID Numbers:
  • Pharmaco15-19-07
First Posted:
Nov 20, 2019
Last Update Posted:
Nov 20, 2019
Last Verified:
Jul 1, 2019
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Nov 20, 2019