Abatacept in Immune Checkpoint Inhibitor Myocarditis

Abatacept in Immune Checkpoint Inhibitor Myocarditis

Status: Recruiting

Conditions: Myocarditis


"Beth Israel Deaconess Medical Center "
Allegheny-Singer Research Institution
Aurora St. Luke's Medical Center
Boston Medical Center
Brigham and Women's Hospital
Cedars-Sinai Medical Center
Cleveland Clinic
Columbia University Medical Center
Franciscan Health
Johns Hopkins University
Lehigh Valley Health Network
MD Anderson Cancer Center
Maine Health
Massachusetts General Hospital
Mayo Clinic
MedStar Health Research Institute - Georgetown University
Memorial Sloan Kettering Cancer Center
Moffitt Cancer Center
Robert Wood Johnson University Hospital
University of California Los Angeles
University of Chicago
University of Kansas Medical Center
University of Kentucky
University of Michigan
University of North Carolina Chapel Hill
University of Pennsylvania
University of Texas Southwestern
University of Utah
University of West Virginia


Los Angeles, California

Kansas City, Kansas

Lexington, Kentucky

Boston, Massachusetts

Ann Arbor, Michigan

New York, New York

Chapel Hill, North Carolina

Bethlehem, Pennsylvania

Dallas, Texas

Houston, Texas

Salt Lake City, Utah

Washington D.C.

Tampa, Florida

Chicago, Illinois

Indianapolis, Indiana

Portland, Maine

Baltimore, Maryland

Rochester, Minnesota

New Brunswick, New Jersey

Cleveland, Ohio

Philadelphia, Pennsylvania

Pittsburgh, Pennsylvania

Morgantown, West Virginia

Milwaukee, Wisconsin

Contact Information:

Hannah K Gilman, MS
[email protected]

Brief Summary:
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.
Detailed Description:

This investigator-initiated randomized trial is being conducted to test whether abatacept, as compared to placebo, is associated with a reduction in MACE among participants who develop myocarditis after treatment with an ICI. Immune checkpoint inhibitors leverage the immune system to treat a wide variety of cancers. Myocarditis is an uncommon immune related adverse event (irAE) secondary to treatment with an ICI. The guideline recommended treatment for ICI myocarditis is cessation of the ICI and administration of corticosteroids. However, despite administration of corticosteroids, the rate of MACE with ICI myocarditis is high. Data from multiple independent international cohorts have shown that the rate of MACE with ICI myocarditis despite administration of corticosteroids ranges from 25-50%.For comparison, the rate of MACE with myocarditis unrelated to an ICI is <5%.

Abatacept is a selective co-stimulation modulator that inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking its interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes. In animal studies of ICI myocarditis, the administration of abatacept led to a reduction in cardiac immune activation and an increase in survival. In retrospective unpublished clinical data, the administration of abatacept to participants with ICI myocarditis on corticosteroids was associated with a reduction in risk of MACE. There are no prospective studies testing whether abatacept is effective among participants with ICI myocarditis. Therefore, the primary aim of this trial is to test in a randomized double-blind placebo-controlled study whether abatacept, administered concurrently with corticosteroids, is associated with a reduction in MACE among participants with recently diagnosed ICI myocarditis

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