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Abatacept in Immune Checkpoint Inhibitor Myocarditis

ConditionsMyocarditis AcuteCancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must have provided informed consent in a manner approved by the Investigator's Institutional Review Board (IRB) prior to any study-related procedure being performed. If a participant is unable to provide informed consent due to his/her medical condition, the participant's legally authorized representative may consent on behalf of the study participant, as permitted by local law and institutional Standard Operating Procedures;

Aged greater than or equal to 18 years at the time of informed consent;

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;

A diagnosis of myocarditis.

Disqualifiers

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.

Recent (≤2 month) exposure to abatacept or belatacept.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: Abatacept plus standard of careExperimental treatment 1 intervention
Group B: Placebo plus standard of carePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major adverse cardiac events

The rates of a composite of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure.

Time frame
6 months

Secondary outcomes

1

The individual components of the primary endpoint.

The rates of the following between groups: cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure

Time frame
6 months
2

Myocarditis illness severity using a 7-point ordinal severity scale containing each of the individual endpoints in a hierarchical ranking order.

The worst score on a 7-point ordinal myocarditis severity scale during the 6 month period from first study treatment. The 7-point ordinal myocarditis severity scale is as follows with more severe outcomes ranked with a higher number: 1. \- No component of the primary endpoint; 2. \- Incident heart failure; 3. \- Significant bradyarrhythmia; 4. \- Significant ventricular tachyarrhythmias; 5. \- Cardiogenic shock; 6. \- Sudden cardiac arrest; 7. \- Cardiovascular death;

Time frame
6 months
3

The increase in serum troponin levels

The proportion of participants in each group with a \>50% increase in serum troponin value at any time during the incident hospitalization and following administration of study drug.

Time frame
6 months
4

The combination of the rates of the primary outcome plus the proportion of patients with a troponin increase.

The rates of a composite of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure plus the proportion of participants in each group with a \>50% increase in serum troponin value at any time during the incident hospitalization and following administration of study drug.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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