Spots Global Cancer Trial Database for Abatacept in Immune Checkpoint Inhibitor Myocarditis
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Trial Identification
Brief Title: Abatacept in Immune Checkpoint Inhibitor Myocarditis
Official Title: AbatacepT foR ImmUne Checkpoint Inhibitor Associated Myocarditis (ATRIUM): A Phase 3, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in ICI Myocarditis
Study ID: NCT05335928
Study Description
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 In retrospective unpublished clinical data, the administration of abatacept to participants with ICI myocarditis on corticosteroids was associated with a reduction in risk of MACE.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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars-Sinai Medical Center, Los Angeles, California, United States
University of California Los Angeles, Los Angeles, California, United States
MedStar Health Research Institute, Georgetown University, Washington, District of Columbia, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago, Chicago, Illinois, United States
Franciscan Health, Indianapolis, Indiana, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
University of Kentucky, Lexington, Kentucky, United States
Maine Health, Portland, Maine, United States
Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Boston Medical Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States
Columbia University Irving Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of North Carolina Chapel Hill, Chapel Hill, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Lehigh Valley Health Network, Bethlehem, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Allegheny-Singer Research Institution, Pittsburgh, Pennsylvania, United States
University of Texas Southwestern, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Utah, Salt Lake City, Utah, United States
University of West Virginia, Morgantown, West Virginia, United States
Aurora St Luke's Medical Center, Milwaukee, Wisconsin, United States
University of British Colombia, Vancouver, British Colombia, Canada
McMaster University, Hamilton, Ontario, Canada
Contact Details
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