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Full Clinical Trial Name

Abatacept for Immune Checkpoint Inhibitor associated Myocarditis: A Phase 3, Investigator-initiated, randomized, double-blind, placebo-controlled study to evaluate the Efficacy and safety of Abatacept compared to placebo in hospitalized participants with Immune Checkpoint Inhibitor associated Myocarditis.

Clinical Trial

  • Heart and Vascular

Phase

Phase
3

Patient Type

Adult
Doctor(s) running this study
Deborah W. Sundlof, DO Ranju Gupta, MD
Location(s):
Call 610-402-9543
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Purpose

The purpose of the study is to evaluate whether abatacept is associated with a reduction in severe cardiac events among participants hospitalized with myocarditis secondary to taking an immune checkpoint inhibitor.

Description

With the increasing use of immune checkpoint inhibitors (ICI) to treat cancer, certain adverse events may occur.  One of the rarer, but dangerous adverse events due to treatment with ICI treatment is myocarditis.  Individuals who are diagnosed with ICI associated myocarditis have a 25-45% chance of developing a severe cardiac adverse event (heart can stop, fast heart rhythm, slow heart rhythm, or heart failure).   There are no definitive treatments for ICI associated myocarditis, with only corticosteroids.  In this study, the research is investigating if abatacept can be an effective and safe treatment for patients diagnosed with ICI associated myocarditis.

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to:

  1. Recent use of FDA-approved immune check point inhibitor within 6 months of myocarditis diagnosis
  2. Hospitalized at time of screening
  3. Diagnosis of myocarditis less than 2 weeks from screening.
  4. Must not have had severe cardiac event 30 days prior to screening

To Participate

Please contact the Network Office of Research and Innovation at 610-402-9543.

 

Learn more about the full clinical trial

Full description at clinicaltrials.gov

Doctor(s) running this study