Phase 3 Study of Abatacept to Reduce Heart Complications in Patients with Immune Checkpoint Inhibitor-Related Myocarditis

What this Trial Is About

Researchers are evaluating whether abatacept, compared to a placebo, can reduce major adverse cardiac events MACE in people hospitalized with myocarditis caused by immune checkpoint inhibitors ICI, a treatment for various cancers. This serious heart inflammation is a rare side effect of ICI therapy. Despite current treatment with corticosteroids and stopping the ICI, the risk of MACE remains high, ranging from 25% to 50%, much greater than myocarditis unrelated to ICI. Participants receive either abatacept or a placebo, both given alongside corticosteroids, to test the impact on MACE. Abatacept is administered intravenously at 10 mgkg after randomization, again 24 hours later, then at 14 days, with an optional fourth dose at 28 days. The placebo group receives identical infusions on the same schedule. The study is randomized, double-blind, and placebo-controlled to ensure unbiased results. During the study, participants are closely monitored for heart-related events, including cardiovascular death, cardiac arrest, shock, arrhythmias, and heart failure, over six months. Researchers also assess myocarditis severity, troponin blood levels indicating heart damage, and other immune-related side effects. Safety and clinical status are evaluated at 90 days and six months after the first infusion. Overall participation lasts up to six months with ongoing assessments and care.

Abatacept in Immune Checkpoint Inhibitor Myocarditis