About this trial
This trial is studying abatacept, a medicine, for people who have heart issues called myocarditis after taking immune checkpoint inhibitors for cancer. The goal is to see if abatacept can reduce serious heart problems compared to a placebo, which looks like the real medicine but has no active ingredients. Myocarditis is a rare side effect of using these cancer treatments, and current treatments may not always work well.
The trial's ID number is NCT05335928. It is a Phase 3 trial, meaning it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated and aims to include 390 participants.
Who can join
Adults aged 18 and older can join this trial. Participation requires that individuals have recently used an approved immune checkpoint inhibitor and are hospitalized with myocarditis. They must also be receiving high doses of corticosteroids. Participants need to meet certain health criteria, and everyone will be checked by the trial team to confirm eligibility.
Conditions
Myocarditis Acute, Cancer
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly assigned to one of two groups. One group will receive abatacept along with standard care, while the other group will get a placebo with standard care. Everyone will receive the treatment through intravenous infusions over several weeks. This means some will get the real medicine, and others will get the placebo, without knowing which one they are receiving.
Where
This trial is running at 29 locations in the United States. 28 of them are currently recruiting.
Allegheny-Singer Research Institution
Pittsburgh, Pennsylvania
Aurora St Luke's Medical Center
Milwaukee, Wisconsin
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Boston Medical Center
Boston, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts
Cedars-Sinai Medical Center
Los Angeles, California
Cleveland Clinic
Cleveland, Ohio
Columbia University Irving Medical Center
New York, New York
The first 8 of 29 sites are listed here. The registry record has the full list.