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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 In retrospective unpublished clinical data, the administration of abatacept to participants with ICI myocarditis on corticosteroids was associated with a reduction in risk of MACE.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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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