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Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors — AMICI  

Cancer Clinical Trial

Official title:
Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4

Clinical Trial Summary

Our knowledge on cardiovascular side effects of immune checkpoint inhibitors (ICIs) is restricted to this date to observational retrospective data (mainly case series and pharamcovigilance analysis). We aim at assessing the incidence of cardiovascular adverse side effects of ICIs by means of a prospective interventional single centre study using multiple biomarkers.

Clinical Trial Description

Immune checkpoint inhibitors (ICIs) are drastically improving cancer prognosis. Cardiovascular adverse side effects of ICIs are though to be rare but may be responsible for ~50% death rates. Prospective screening for cardiovascular and muscular immune related side effects has not been undertaken independently from the industry. The aim is to describe the incidence of these side effects by means of serial assessment in patients undergoing ICI therapy for cancer. Biomarkers as ECG, echocardiography, cardiac magnetic resonance imaging and long-term ECG monitoring will be undertaken at inclusion (before ICI therapy is started), and during the first cycle treatments and at 6 months follow-up. Mean endpoint encompasses cardiovascular and muscular adverse side effects between the 2nd and the 3rd ICI cycle. Secondary endpoints include cardiovascular and muscular adverse side effects at 6 months follow-up, and the incidence of individual side effects. 4 ancillary studies based on patients' blood biobanking are also planned. Their objectives are: - to assess sensitivity of heart failure biomarkers in predicting cardiovascular events under ICI, - to assess sensitivity of cytokine biomarkers in predicting cardiovascular events under ICI, - to bank cells to induce cardiomyocytes from stem cells - to bank DNA to identify genetic factors related to occurrence of cardiovascular events under ICI ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04586894
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase
Start date November 6, 2020
Completion date July 1, 2022
View Details
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