RecruitingPHASE3INTERVENTIONAL

Abatacept in Immune Checkpoint Inhibitor Myocarditis

This study is for people who have heart inflammation (myocarditis) that has developed after receiving certain cancer treatments called immune checkpoint inhibitors. These cancer treatments work by boosting your immune system, but sometimes they can also cause it to attack the heart. We already know that standard treatments like steroids don't always fully prevent serious heart problems in these cases. This study aims to find out if an additional medicine called abatacept, given alongside steroids, can help reduce the risk of serious heart issues like heart attacks, dangerous heart rhythms, or heart failure. Participants will either receive abatacept or a dummy drug (placebo) to see which is more effective.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Massachusetts General Hospital

Enrolment target

390

Start

02 Jul 2022

Estimated completion

20 Apr 2027

Myocarditis Acute Cancer

What is this study about?

This study is looking at a new way to treat a specific type of heart inflammation, called myocarditis. This heart issue can sometimes happen to people undergoing certain cancer treatments. These treatments, known as immune checkpoint inhibitors, are very good at helping your body fight cancer, but occasionally they can cause your immune system to mistakenly attack other parts of the body, including your heart. When this happens, it's a serious condition.

Even with the best standard treatments currently available, such as high-dose steroids, people with this type of myocarditis can still experience serious heart problems. These might include things like a heart attack, dangerously fast or slow heartbeats, or the heart struggling to pump blood properly. Researchers have noticed that these serious heart problems are much more common in people with myocarditis caused by cancer treatment compared to other types of myocarditis.

That's where this study comes in. It's investigating if an additional medicine called abatacept can make a difference. Abatacept works by calming down parts of the immune system that might be overactive. Early research and some patient information suggest that abatacept could help reduce damage to the heart and improve outcomes for people with this type of myocarditis. This study aims to confirm these findings in a careful and organised way, comparing abatacept with a dummy drug (placebo) to see if it truly helps reduce serious heart problems when given alongside standard steroid treatment.

Key takeaways

This study evaluates abatacept for heart inflammation (myocarditis) from cancer treatment.
It aims to reduce serious heart problems in people with this condition.
Participants will receive either abatacept or a dummy drug alongside standard care.
The study includes careful monitoring during hospitalisation and follow-up.
It's a 'double-blind' study, meaning no one knows who gets the active drug.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to take part in this study, you need to meet a few important conditions. Firstly, you must be 18 years or older. You also need to have given your consent, meaning you understand the study and agree to participate. If you're too unwell to give consent, a family member or legal guardian might be able to do so for you, as allowed by local rules.

Crucially, you must have recently (within the last six months) received an immune checkpoint inhibitor for cancer treatment. This study is specifically for people whose myocarditis developed after this type of cancer treatment. You also need to have a clear diagnosis of myocarditis and be in hospital at the time you join the study.

Finally, your heart needs to show signs of ongoing injury, which doctors will check using a blood test called troponin. This blood test result needs to be significantly higher than normal, indicating that your heart is still affected, and this high level must have been noted recently. You also need to be receiving or about to start a high dose of a steroid medication called solumedrol for your myocarditis.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently received a type of cancer treatment called an 'immune checkpoint inhibitor'?
Have you been diagnosed with myocarditis (heart inflammation)?
Are you currently in hospital for your myocarditis?
Are you receiving or about to start high-dose steroid treatment for your heart inflammation?
Does your recent blood test show ongoing signs of heart injury (high troponin level)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive the study drug abatacept or a dummy drug (placebo) through an injection, alongside the standard steroid treatment your doctors are already giving you. Neither you nor your doctors will know whether you are receiving abatacept or the placebo. You'll need to remain in hospital for a period, where doctors will closely monitor your heart and overall health. This will involve regular blood tests, heart scans, and checks on your heart's electrical activity (ECGs) to see how you are responding to treatment.

During your time in the study, medical staff will carefully watch for any changes in your condition or any side effects. After you leave the hospital, there will be follow-up appointments to continue monitoring your heart health and ensure your recovery is progressing well. The total duration of your participation in the study will involve initial treatment while in hospital and then follow-up appointments over a period of time, which your study doctor will explain in detail.

Potential risks and benefits

Participating in this study might offer a potential benefit if abatacept proves to be effective in reducing serious heart problems caused by your cancer treatment. However, as with any medical study, there are potential risks, including side effects from the study drug or unknown effects. You will be closely monitored for any adverse reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (31)

Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
University of California Los Angeles
Verified postcode
Los Angeles, United States· Recruiting
MedStar Health Research Institute, Georgetown University
Verified postcode
Washington D.C., United States· Recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
University of Chicago
Verified postcode
Chicago, United States· Recruiting
Franciscan Health
Verified postcode
Indianapolis, United States· Recruiting
University of Kansas Medical Center
Verified postcode
Kansas City, United States· Recruiting
University of Kentucky
Verified postcode
Lexington, United States· Recruiting
Maine Health
Verified postcode
Portland, United States· Recruiting
Johns Hopkins
Verified postcode
Baltimore, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States· Recruiting

Common questions

What is myocarditis?

Myocarditis is inflammation of the heart muscle, which can make it harder for your heart to pump blood effectively.

What are immune checkpoint inhibitors?

These are a type of cancer treatment that helps your body's own immune system fight cancer cells more effectively.

What is abatacept?

Abatacept is a medication that helps to quiet down an overactive immune system. It's used for some autoimmune conditions.

Will I know if I'm getting the real drug or a dummy drug?

No, neither you nor your doctors will know if you are receiving abatacept or the placebo (dummy drug) during the study. This helps ensure fair results.

What if my condition gets worse during the study?

You will be closely monitored by medical staff, and if your condition changes or worsens, your doctors will provide appropriate medical care and may remove you from the study if it's in your best interest.

How to find out more

Hannah K Gilman, MS

hkgilman@mgh.harvard.edu 6177261019 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.