Actively Recruiting
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Led by Massachusetts General Hospital · Updated on 2025-09-10
390
Participants Needed
31
Research Sites
250 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent or had a legally authorized representative consent prior to study procedures
- Age 18 years or older at time of consent
- Received an FDA-approved immune checkpoint inhibitor within 6 months before myocarditis diagnosis
- Diagnosed with myocarditis
- Hospitalized at time of randomization
- Receiving or intending to start 1000 mg solumedrol per day for myocarditis within 24 hours of first study drug dose
- Serum troponin level at least 5 times above institutional upper limit within 10 days prior to randomization
- Laboratory values within 48 hours prior to randomization: white blood cell count >2,500/µL, absolute neutrophil count >1,500/µL, ALT or AST less than 20 times upper institutional limit
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception until 90 days after last study drug dose; men must agree to use effective contraception until 90 days after last study drug dose
- Willing and able to follow all study requirements and restrictions
You will not qualify if you...
- Experienced sudden cardiac arrest, cardiogenic shock, significant bradyarrhythmia requiring pacemaker, or significant tachyarrhythmia requiring intervention within 30 days prior to randomization
- Exposure to abatacept or belatacept within 2 months prior to randomization
- Recent (within 2 months) use of specified non-corticosteroid immunosuppressants (mycophenolate, JAK STAT inhibitors, tacrolimus, anti-thymocyte globulin, alemtuzumab, infliximab, plasma exchange)
- Currently enrolled in another interventional study for ICI-related toxicities
- Pregnant, breastfeeding, or planning pregnancy during study or 90 days after last study drug dose
- Male planning to father a child or donate sperm during study or 30 days after last study drug dose
- Active, chronic, or recurrent viral infections making participant unsuitable (including active hepatitis B or C, herpes zoster or simplex, active Covid-19 infection)
- Known active or incompletely treated tuberculosis or systemic bacterial/fungal infections
- Received live vaccine within 4 weeks prior to first study drug dose or expected need for live vaccine during study and 90 days after last dose
- Any medical condition or factors that may interfere with study conduct, results, or participant safety as judged by investigator
- History of noncompliance with scheduled appointments likely to interfere with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 02127
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
MedStar Health Research Institute, Georgetown University
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Franciscan Health
Indianapolis, Indiana, United States, 46237
Actively Recruiting
7
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
8
University of Kentucky
Lexington, Kentucky, United States, 40536-0200
Actively Recruiting
9
Maine Health
Portland, Maine, United States, 04102
Actively Recruiting
10
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
11
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
12
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
13
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
14
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
15
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
16
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
17
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
18
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
19
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
20
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7075
Actively Recruiting
21
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
Lehigh Valley Health Network
Bethlehem, Pennsylvania, United States, 18017
Actively Recruiting
23
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
24
Allegheny-Singer Research Institution
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
25
University of Texas Southwestern
Dallas, Texas, United States, 72535
Actively Recruiting
26
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
27
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
28
University of West Virginia
Morgantown, West Virginia, United States, 26506
Actively Recruiting
29
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
30
University of British Colombia
Vancouver, British Colombia, Canada, V5Z 1M9
Actively Recruiting
31
McMaster University
Hamilton, Ontario, Canada, L8V 1C3
Actively Recruiting
Research Team
H
Hannah K Gilman, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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