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Full Name

Abatacept for Immune Checkpoint Inhibitor associated Myocarditis: A Phase 3, Investigator-initiated, randomized, double-blind, placebo-controlled study to evaluate the Efficacy and safety of Abatacept compared to placebo in hospitalized participants with Immune Checkpoint Inhibitor associated Myocarditis.

Description

With the increasing use of immune checkpoint inhibitors (ICI) to treat cancer, certain adverse events may occur. One of the rarer, but dangerous adverse events due to treatment with ICI treatment is myocarditis. Individuals who are diagnosed with ICI associated myocarditis have a 25-45% chance of developing a severe cardiac adverse event (heart can stop, fast heart rhythm, slow heart rhythm, or heart failure). There are no definitive treatments for ICI associated myocarditis, with only corticosteroids. In this study, the research is investigating if abatacept can be an effective and safe treatment for patients diagnosed with ICI associated myocarditis.

Purpose

The purpose of the study is to evaluate whether abatacept is associated with a reduction in severe cardiac events among participants hospitalized with myocarditis secondary to taking an immune checkpoint inhibitor.

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to:

Recent use of FDA-approved immune check point inhibitor within 6 months of myocarditis diagnosis
Hospitalized at time of screening
Diagnosis of myocarditis less than 2 weeks from screening.
Must not have had severe cardiac event 30 days prior to screening