2184TiP - Extensive cardiovascular characterization and follow-up of patients receiving immune checkpoint inhibitors: A prospective multicenter study

Background

The increasing use of immune checkpoint inhibitors (ICIs) in the treatment of both advanced and early stages of various malignancies has resulted in a substantial increase in the incidence of cardiovascular (CV) immune-related adverse events (irAEs). The current follow-up guidelines are based on anecdotal evidence and expert opinions, due to a lack of solid data and prospective studies. As many questions remain unanswered, cardiac monitoring, in patients receiving ICIs, is not always implemented by oncologists. Hence, an urgent need to investigate the possible short- and long-term CV effects of ICIs, as ICI approval is continuing to expand to the (neo)adjuvant setting.

Trial design

We have initiated a prospective, multicenter study, i.e., the CAVACI trial, in which a minimum of 276 patients with a solid tumor, eligible for ICI treatment, will be enrolled. The study consists of routine investigations of blood parameters (troponin and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, in particular) and a thorough CV follow-up (electrocardiograms, transthoracic echocardiograms, and coronary calcium scoring) at fixed time points for a total period of two years. The primary endpoint is the cumulative incidence of troponin elevation in the first three months of ICI treatment, compared to baseline levels. Furthermore, secondary endpoints include incidence above the upper limit of normal of both troponin and NT-proBNP levels, evolution in troponin and NT-proBNP levels, the incidence of CV abnormalities/major adverse cardiac events, evaluation of associations between patient characteristics/biochemical parameters and CV events, transthoracic echocardiography parameters, electrocardiography parameters, and progression of coronary atherosclerosis. Recruitment of patients started in January 2022. Enrolment is ongoing in AZ Maria Middelares, Antwerp University Hospital, AZ Sint-Vincentius Deinze, and AZ Sint-Elisabeth Zottegem.

Clinical trial identification

NCT05699915, registered 26 January 2023.

Editorial acknowledgement

Legal entity responsible for the study

Antwerp University Hospital.

Funding

Has not received any funding.

Disclosure

J. De Sutter: Financial Interests, Personal, Advisory Role: Novartis, Bayer US, Llc. D. Vervloet: Financial Interests, Personal, Advisory Role: Novartis, Pfizer, AstraZeneca Co.; Financial Interests, Personal, Speaker’s Bureau: Novartis, Pfizer, Izidok, AstraZeneca Co.; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Pfizer, Novartis. V. Moerman: Financial Interests, Personal, Other, Honoraria: Menarini; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Menarini, Daiichi Sankyo Pharmaceutical, Bayer US, Llc. N. Van de Veire: Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Pfizer, Menarini, Daiichi Sankyo Pharmaceutical; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Boehringher Ingelheim. A. Willems: Financial Interests, Personal, Other, Employment: Maatschap Cardiologie. M. Peeters: Financial Interests, Personal, Advisory Role: Amgen, Bayer, Ipsen, Remedus, Sanofi, Sirtex Medical, Terumo, Merck, MSD, Qurin; Financial Interests, Personal, Leadership Role: Qurin; Financial Interests, Personal, Speaker’s Bureau: Amgen, Bayer US, Llc, Merck Serono, Roche, Sanofi, Servier, Sirtex Medical; Financial Interests, Personal, Stocks or ownership: Bimini Biotech; Financial Interests, Personal, Other, Honoraria: Amgen, Bayer US, Llc, Sanofi, Servier, Merck, Roche, Sirtex Medical; Financial Interests, Personal, Research Funding: Amgen, Bayer US, Llc, Ipsen, Novartis, Roche. H. Prenen: Financial Interests, Personal, Advisory Role: Biocartis, Cureteq; Financial Interests, Personal, Other, Honoraria: Amgen, Roche, Sanofi, AstraZeneca, Bayer. C. Vulsteke: Financial Interests, Personal, Advisory Board: MSD, Janssen-Cilag, GSK, Astellas Pharma, BMS, Leo Pharma, Bayer, AstraZeneca, Pfizer, Merck; Financial Interests, Institutional, Research Grant, Funding for research project on immune related toxicities: MSD. All other authors have declared no conflicts of interest.