NCT04294771

JOint Use of Database to Identify Risk Factors of CARDio-vascular Toxicity Induced by Immune Checkpoint Inhibitors

JOint Use of Database to Identify Risk Factors of CARDio-vascular Adverse Reactions Induced by Immune Checkpoint InhibiTors: VigiBase, Entrepot de Données de Santé (EDS), Système National Des Données de Santé (SNDS) Databases and a Retrospective International Multicenter Registry of ICI-associated Myocarditis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500,000 (estimated)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Immune checkpoint inhibitors (ICIs) might induce high grade immune-related adverse events (irAEs) involving the cardio-vascular system. This study investigates reports of cardio-vascular toxicity associated with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase, Assistance Publique Hopitaux de Paris Entrepot de Données de Santé (APHP.EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis

Detailed description

ICIs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and in combination. Thus, irAEs can occur and risk factors for such events have been scarcely described. Here, the investigators will use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify risk factors for cases of cardiovascular adverse drug reaction following treatment with ICIs, the investigators will also use two french databases : APHP Entrepot de Données de Santé (EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis

Conditions

• Myocarditis
• Cardiomyopathies
• Heart Diseases
• Cardiovascular Diseases
• Pericarditis
• Vasculitis

Interventions

Type	Name	Description
DRUG	ICI	Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the ATC following list (ATC classification): Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC3)

Timeline

• Start date: 2019-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2020-03-04
• Last updated: 2023-09-15

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study