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OncoMatch/Clinical Trials/NCT05335928

Abatacept in Immune Checkpoint Inhibitor Myocarditis

Is NCT05335928 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Abatacept plus for myocarditis acute.

Phase 3RecruitingMassachusetts General HospitalNCT05335928Data as of May 2026

Treatment: Abatacept plusThe 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.

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Extracted eligibility criteria

Prior therapy

Must have received: immune checkpoint inhibitor

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).

Cannot have received: abatacept (abatacept)

Recent (≤2 month) exposure to abatacept

Cannot have received: belatacept (belatacept)

Recent (≤2 month) exposure to belatacept

Cannot have received: non-corticosteroid immunosuppressive therapies (mycophenolate, JAK STAT inhibitors, upadacitinib, tofacitinib, baricitinib, filgotinib, tacrolimus, anti-thymocyte globulin, alemtuzumab, infliximab, plasma exchange)

Exception: intravenous immunoglobulin is permitted

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.

Lab requirements

Blood counts

total white blood cell (wbc) count >2,500/μl; absolute neutrophil count (anc) >1,500/μl

Liver function

alt or ast <20 times the upper limit of the institutional normal ranges

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Cedars-Sinai Medical Center · Los Angeles, California
  • University of California Los Angeles · Los Angeles, California
  • MedStar Health Research Institute, Georgetown University · Washington D.C., District of Columbia
  • Moffitt Cancer Center · Tampa, Florida
  • University of Chicago · Chicago, Illinois

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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