Abatacept in Immune Checkpoint Inhibitor Myocarditis
Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT05335928
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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.
Interventions
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Abatacept plus
(Drug)
Up to 4 study drug infusions at 10 mg/kg, IV Drug: Standard of care Local standard of care per written policies or guidelines Other Name: SoC
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Placebo
(Drug)
Drug: Standard of care Local standard of care per written policies or guidelines Other Name: SoC
Eligibility criteria
Conditions
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 D.C., 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
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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