Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events

NCT ID: NCT04169503

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

17562 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-14

Study Completion Date

2020-02-29

Brief Summary

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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

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alexandre Joachim

Caen, Basse Normandie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Joachim Alexandre, MD

Role: CONTACT

+33231064670

Facility Contacts

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Joachim Alexandre, MD

Role: primary

+33231064670

Other Identifiers

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Pharmaco15-19-07

Identifier Type: -

Identifier Source: org_study_id

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