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

Launched by GROUPE HOSPITALIER PITIE-SALPETRIERE · Mar 2, 2020

Keywords

ClinConnect Summary

**Trial Summary: Understanding Heart Risks from Immune Checkpoint Inhibitors**

This clinical trial is examining how certain cancer treatments known as immune checkpoint inhibitors (ICIs) can affect heart health. These treatments, which include drugs like Nivolumab and Pembrolizumab, have been linked to serious heart-related side effects, such as myocarditis (inflammation of the heart) and other cardiovascular issues. Researchers are using several large health databases and registries to identify patients who have experienced these heart problems after receiving ICIs. By analyzing this information, the study aims to better understand the risk factors and improve safety for future patients.

To participate in this trial, individuals must have had heart-related side effects reported in specific health databases and must have received treatment with one of the listed ICIs. The study is open to all patients, regardless of age or gender. If you join the trial, you can expect to contribute to important research that could help improve the way these treatments are used and monitored in the future. This study is currently recruiting participants, and your involvement could make a difference in understanding and managing the risks associated with these cancer treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2025
• • Case reported in the APHP Entrepot de Données de Santé (EDS) database of individual safety case reports to 01/01/2025
• • Case reported in the Système National Des Données de Santé (SNDS) Database of individual safety case reports to 01/01/2025
• • Case reported in a retrospective international multicenter registry of ICI-associated myocarditis to 01/01/2025
• • Adverse event reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT)
• • Patients treated with ICIs included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), Cemiplimab (L01XC33)
• Exclusion Criteria:
• • Chronology not compatible between the drug and the toxicity