Immune CHeckpoint Inhibitors Monitoring of Adverse Drug ReAction (CHIMeRA)

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Myositis; Ophthalmopathy; Cardiac Disease; Arthritis; Cancer; Neuropathy; Endocrine System Diseases; Autoimmune Diseases

Treatments: Drug: Immune checkpoint inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT03492242

CIC1421-18-06

Details and patient eligibility

About

Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) from rhumatologic, endocrinologic, cardiac or other system origin. This study investigates reports of drug induced irAEs with treatment including anti-PD1, Anti-PDL-1, and Anti-CTLA4 classes using the World Health Organization (WHO) database VigiBase and the french database Base Nationale de PharmacoVigilance (BNPV).

Full description

Immune checkpoint inhibitors (ICIs) have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, immune-related adverse events (irAEs) can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, and in the Base Nationale de PharmacoVigilance (BNPV) which is the french pharmacovigilance database, to identify cases of adverse drug reaction including arthiritis, auto-immune induced diseases, cardiac diseases, endocrinologic diseases, following treatment with ICIs.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Case reported in the World Health Organization (WHO) database and Base Nationale de Pharmacovigilance (BNPV) of individual safety case reports to 01/05/2018
• Adverse events reported
• Patients treated with ICIs, in monotherapy or combination, included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).

Exclusion criteria

• Chronology not compatible between the drug and the toxicity

Trial design

1,000 participants in 1 patient group

Adverse drug reaction induced by immune checkpoint inhibitors

Description:

Case reported in the World Health Organization (WHO) and the Base Nationale de PharmacoVigilance of patient treated by ICI, with a chronology compatible with the drug toxicity

Treatment:

Drug: Immune checkpoint inhibitor