Abatacept in Immune Checkpoint Inhibitor Myocarditis

Part of paid clinical trials in Los Angeles, California.

Sponsor: Massachusetts General Hospital
Study ID: NCT05335928
Phase: PHASE3
Status: Recruiting

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Conditions

Cancer
Myocarditis Acute

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

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
Placebo — DRUG
Drug: Standard of care Local standard of care per written policies or guidelines Other Name: SoC

Study Details

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.

Key Dates

Start date: Jul 2, 2022
Status verified: Sep 2025
Primary completion: Nov 20, 2026
Completion: Apr 20, 2027

Study Design

Enrollment: 390 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: 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.
Placebo Comparator: Placebo plus standard of care
Placebo will be administered at the same intervals.

Primary Outcome Measure

Major adverse cardiac events [ Time Frame: 6 months ]

Central Contacts

Hannah K Gilman, MS
6177261019
[email protected]

Locations (29)

Facility	City	State	ZIP	Site coordinators
Cedars-Sinai Medical Center	Los Angeles	California	02127	Kiranbir Josan, MD Kiranbir Josan, MD (PRINCIPAL_INVESTIGATOR)
University of California Los Angeles	Los Angeles	California	90095	Eric Yang, MD Eric Yang, MD (PRINCIPAL_INVESTIGATOR)
MedStar Health Research Institute, Georgetown University	Washington D.C.	District of Columbia	20010	Hayder Hashim Hayder Hashim (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer Center	Tampa	Florida	33612	Mohammed v Mohammed Alomar (PRINCIPAL_INVESTIGATOR)
University of Chicago	Chicago	Illinois	60637	Jeanne DeCara Jeanne DeCara (PRINCIPAL_INVESTIGATOR)
Franciscan Health	Indianapolis	Indiana	46237	Ryan Daly Ryan Daly, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical Center	Kansas City	Kansas	66160	Charles Porter Charles Porter, MD (PRINCIPAL_INVESTIGATOR)
University of Kentucky	Lexington	Kentucky	40536-0200	Amit Arbune Amit Arbune, MD (PRINCIPAL_INVESTIGATOR)
Maine Health	Portland	Maine	04102	Maxwell Afari Maxwell Afari, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins	Baltimore	Maryland	21287	Joban Vaishnav Joban Vaishnav (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02115	Abul Aritizia, MD Aarti Asnani, MD (PRINCIPAL_INVESTIGATOR)
Boston Medical Center	Boston	Massachusetts	02118	Omar Siddiqi Omar Siddiqi, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's Hospital	Boston	Massachusetts	02215	Anju Nohria, MD [email protected] Anju Nohria, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital	Boston	Massachusetts	02114	Daniel Zlotoff, MD, PhD [email protected] 6177262000 Kerry Reynolds, MD (SUB_INVESTIGATOR)
University of Michigan	Ann Arbor	Michigan	48109	Salim Hayek, MD [email protected] Salim Hayek, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic	Rochester	Minnesota	55905	Joerg Herrmann Joerg Herrmann, MD (PRINCIPAL_INVESTIGATOR)
Robert Wood Johnson University Hospital	New Brunswick	New Jersey	08901	Amna Zafar Amna Zafar (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical Center	New York	New York	10032	Jayant Raikhelkar Jayant Raikhelkar (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Dipti Gupta, MD Dipti Gupta, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina Chapel Hill	Chapel Hill	North Carolina	27599-7075	Brian Jensen, MD Brian Jensen, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic	Cleveland	Ohio	44195	Rohit Moudgil Rohit Moudgil (PRINCIPAL_INVESTIGATOR)
Lehigh Valley Health Network	Bethlehem	Pennsylvania	18017	Nicholas Trask Deborah Sundlof (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Michael Fradley Michael Fradley (PRINCIPAL_INVESTIGATOR)
Allegheny-Singer Research Institution	Pittsburgh	Pennsylvania	15212	Valentyna Ivanova Ivanova Ivanova, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern	Dallas	Texas	72535	Saketh Nadimpalli [email protected] Vlad Zaha, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer Center	Houston	Texas	77030	Nicolas Palaskas [email protected] Nicolas Palaskas, MD (PRINCIPAL_INVESTIGATOR)
University of Utah	Salt Lake City	Utah	84132	Anees Daud, MD Anees Daud, MD (PRINCIPAL_INVESTIGATOR)
University of West Virginia	Morgantown	West Virginia	26506	Brijesh Patel Brijesh Patel, MD (PRINCIPAL_INVESTIGATOR)
Aurora St Luke's Medical Center	Milwaukee	Wisconsin	53215	Manmeet Singh Manmeet Singh (PRINCIPAL_INVESTIGATOR)

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By research site

Cedars-Sinai Medical Center· Los Angeles, CA University of California Los Angeles· Los Angeles, CA MedStar Health Research Institute, Georgetown University· Washington D.C., DC Moffitt Cancer Center· Tampa, FL University of Chicago· Chicago, IL Franciscan Health· Indianapolis, IN

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