EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance Database

NCT05934214 | Completed FDA Drug

• 1 other identifier: CIC1421-23-05
• Study Type: observational
• Target: 141,630
• Locations: 1 country
• Sites: 2

Brief Summary

This is an observational, retrospective pharmacovigilance study based on reports registered and transmitted in VigiBase®, the WHO's international database. This study includes all reports identified as exposure to an ICI and suspect of inducing adverse drug reaction. The aim of the study is to characterize immune-related adverse reactions associated with immune-checkpoint inhibitors, particularly their time-to-onset, co-occurence, factors associate with their over-report and fatality.

Conditions

Cancer; Immune-related Adverse Event; Immune Checkpoint Inhibitor-Related Myocarditis

Keywords

Immune checkpoint inhibitors

Outcome Measures

Primary Outcomes (1)

• Factors associated with an increased rate of fatality among reports with an immune-related adverse event (irAE).

  Reports with a fatal outcome will be compared to reports with no fatal outcome. Odds ratio will be calculated to compare covariates potentially associated with an increase risk of fatality, including irAE type, cancer type reported, patient's age, gender, comorbidities, type of ICI or ICI combination and other treatments.

  any report prior to january 2023

Secondary Outcomes (3)

• Factors associated with an increased reporting of main irAE types

  any report prior to january 2023

• Time to onset for each irAE type

  any report prior to january 2023

• Rate of relapse with treatment rechallenge

  any report prior to january 2023

Study Arms (1)

immune-related adverse event reaction

Reports of identified immune-related adverse event reaction

Drug: Immune checkpoint inhibitor

Interventions

Immune checkpoint inhibitor DRUG

Reports associated with an an Immune checkpoint inhibitor with a status of "Suspect" or "Interacting" ICI will include the following list of FDA-apporved ICIs: nivolumab, pembrolizumab, cemiplimab, dostarlimab, durvalumab, atezolizumab, avelumab, ipilimumab, tremelimumab, relatlimab

immune-related adverse event reaction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any reports with an immune-related drug reaction attributed to an immune checkpoint inhibitor

You may qualify if:

• Any report with an ICI "Suspect" or "Interacting" with the reported adverse drug reaction.

You may not qualify if:

• ICI not FDA approved
• No irAE identified in report

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead
• Institut Curie: collaborator

Study Sites (2)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.

Paris, 75013, France

Location

CIC Paris-Est / Institut Curie

Paris, 75013, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 6, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 29, 2024
• Last Updated: March 5, 2024

Record last verified: 2023-07

Locations

FR (2)