Abatacept for Immune Checkpoint Inhibitor Myocarditis

Abatacept in Immune Checkpoint Inhibitor Myocarditis

Recruiting Phase 3 Interventional Study
Myocarditis Acute Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
390 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for

This trial is looking for adults who have been hospitalized with myocarditis caused by immune checkpoint inhibitors. Participants will receive either abatacept or a placebo to see if it helps prevent serious heart problems.

Are You a Good Fit for This Trial?
Must be taking Solumedrol

You may be able to join if

  • I am at least 18 years old.
  • I have been hospitalized for myocarditis.
  • I have used an immune checkpoint inhibitor within the last 6 months.
  • I have a diagnosis of myocarditis.
  • I am currently on 1000 mg of solumedrol per day or will start it soon.
  • I have had a heart injury as shown by a specific blood test.
  • I am willing to follow all study requirements.

You may not be able to join if

  • I have had a sudden cardiac arrest in the past 30 days.
  • I have had significant heart rhythm issues in the past 30 days.
  • I have used abatacept or belatacept in the last 2 months.
  • I am currently in another clinical trial for ICI-related treatments.
  • I am pregnant, breastfeeding, or planning to become pregnant.
  • I have an active viral infection that makes me unsuitable.
  • I have active tuberculosis or a history of unaddressed tuberculosis.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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 ventricul…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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 leg…
Contacts

Hannah K Gilman, MS

6177261019

hkgilman@mgh.harvard.edu

CONTACT