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

November 17, 2019 updated by: University Hospital, Caen

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

17562

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse Normandie
      • Caen, Basse Normandie, France, 14000
        • Recruiting
        • Alexandre Joachim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with immune checkpoint inhibitors and experiencing irAEs

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of occurrence of second immune-related adverse events (irAEs)
Time Frame: 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
Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of cases experiencing an initial irAEs
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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)..

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

November 17, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Pharmaco15-19-07

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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