Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
390 participants
INTERVENTIONAL
2022-07-02
2027-04-20
Brief Summary
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Detailed Description
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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 In retrospective unpublished clinical data, the administration of abatacept to participants with ICI myocarditis on corticosteroids was associated with a reduction in risk of MACE.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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Abatacept plus standard of care
Abatacept (10 mg/kg) will be administered IV after randomization, again at 24 hours after first study drug treatment, at 14 days after first study drug treatment and an optional 4th dose at 28 days.
Abatacept plus
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
Placebo plus standard of care
Placebo will be administered at the same intervals.
Placebo
Drug: Standard of care Local standard of care per written policies or guidelines Other Name: SoC
Interventions
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Abatacept plus
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
Placebo
Drug: Standard of care Local standard of care per written policies or guidelines Other Name: SoC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged greater than or equal to 18 years at the time of informed consent;
3. Recent use of an FDA-approved immune checkpoint inhibitor (ICI, defined as administered an immune checkpoint inhibitor ≤ 6 months of myocarditis diagnosis), alone or in combination with other cancer therapies (i.e. chemotherapy, radiation therapy or targeted therapy). The FDA-approved ICI could be given as part of a clinical trial but not in combination with a new investigational agent which may cause myocarditis;
4. A diagnosis of myocarditis.
5. Hospitalized at the time of randomization;
6. On 1000 mg of solumedrol per day for myocarditis or with an intent to initiate 1000 mg of solumedrol per day for myocarditis within 24 hours of first administration of study drug;
7. Serum evidence of ongoing myocardial injury: Serum evidence of ongoing myocardial injury will be defined as an institutional troponin (either conventional or high-sensitivity troponin I or T, using the standard institutional assay) with a value that is ≥5 times the upper limit of the reference standard normal for that institution. The troponin assay may be adjusted based on sex depending on institutional standards. This value of troponin of ≥5 times above the institutional upper limits of normal value must be noted within 10 days prior to potential randomization. The 10-day period can be in the outpatient or inpatient setting. For example, a participant with a troponin value that on one occasion was ≥5 times the upper limits of institutional normal in the 10-day window prior to potential randomization (whether in the inpatient or outpatient setting), but later decreases below that threshold, typically due to starting corticosteroids, would still be considered eligible;
8. The following laboratory parameters, not older than 48 hours at the time of randomization, and measured as part of usual care:
* Total white blood cell (WBC) count \>2,500/μl
* Absolute neutrophil count (ANC) \>1,500/μL
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<20 times the upper limit of the institutional normal ranges;
9. Women of childbearing potential (i.e., not postmenopausal, or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test prior to randomization. Participating women of childbearing potential must be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug. Participating men must also be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug; and
10. Must be willing and able to abide by all study requirements and restrictions.
Exclusion Criteria
* A sudden cardiac arrest
* Cardiogenic shock as defined. A significant bradyarrhythmia (Mobitz type II second degree atrioventricular block or third degree (complete) atrio-ventricular (AV) block, for which an intervention with a temporary or permanent pacemaker is completed or recommended).
* A significant tachyarrhythmia (ventricular fibrillation of any duration or sustained ventricular tachycardia (\>30 seconds, \>120 beats per minute); or a ventricular tachyarrhythmia requiring intervention.
2. Recent (≤2 month) exposure to abatacept or belatacept.
3. Concurrent or recent (≤2 month) use of the following non-corticosteroid immunosuppressive therapies prior to randomization: mycophenolate, JAK STAT inhibitors (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib), tacrolimus, anti-thymocyte globulin, alemtuzumab, infliximab, and plasma exchange. The use of intravenous immunoglobulin is permitted prior to randomization and during study treatment.
4. Currently enrolled in another interventional study utilizing systemic agents for the management of ICI-related toxicities.
5. Female who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 90 days after the last dose of study drug.
6. Male who is considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug.
7. Any active, chronic, or recurrent viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study. These may include hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, and disseminated (even a single episode) herpes simplex. Active HBV and HCV are defined as: HBV: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for Hepatitis B core antibody (HBc Ab) positive (+) participants; HCV: HCV ribonucleic acid (RNA) detectable in any participant with anti-HCV antibody (HCV Ab). Patients with active Covid-19 infection will be excluded. This is defined as the period of ongoing symptoms in the setting of a positive Covid-19 test, or until 10 days after symptom onset and after resolution of fever for at least 24 hours, without the use of fever-reducing medications.
8. Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections;
9. Receipt of any live vaccine within four weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 90 days after the last dose of IV study drug.
10. Any medical condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study.
11. Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Tomas G. Neilan, MD
Director, Cardio-Oncology Program
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Kiranbir Josan, MD
Role: primary
Eric Yang, MD
Role: primary
Hayder Hashim
Role: primary
Mohammed v
Role: primary
Jeanne DeCara
Role: primary
Ryan Daly
Role: primary
Charles Porter
Role: primary
Amit Arbune
Role: primary
Maxwell Afari
Role: primary
Joban Vaishnav
Role: primary
Abul Aritizia, MD
Role: primary
Omar Siddiqi
Role: primary
Joerg Herrmann
Role: primary
Amna Zafar
Role: primary
Jayant Raikhelkar
Role: primary
Dipti Gupta, MD
Role: primary
Brian Jensen, MD
Role: primary
Rohit Moudgil
Role: primary
Nicholas Trask
Role: primary
Michael Fradley
Role: primary
Valentyna Ivanova
Role: primary
Anees Daud, MD
Role: primary
Brijesh Patel
Role: primary
Manmeet Singh
Role: primary
Margot Davis
Role: primary
Darryl Leong
Role: primary
References
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Heymans S, Van Linthout S, Kraus SM, Cooper LT, Ntusi NAB. Clinical Characteristics and Mechanisms of Acute Myocarditis. Circ Res. 2024 Jul 5;135(2):397-411. doi: 10.1161/CIRCRESAHA.124.324674. Epub 2024 Jul 4.
Other Identifiers
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2021P003690
Identifier Type: -
Identifier Source: org_study_id
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