Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug aims to shield hearts from cancer treatment side effect

NCT ID NCT05335928

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether abatacept (Orencia) can reduce major heart complications in cancer patients who develop myocarditis (heart inflammation) from immune checkpoint inhibitors. About 390 hospitalized adults will receive either abatacept or placebo plus standard care. The goal is to see if abatacept lowers the risk of heart-related death, cardiac arrest, shock, dangerous heart rhythms, or heart failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Abatacept (Orencia)
What this could lead to
If it works, this could provide a new treatment to prevent serious heart problems in cancer patients who develop heart inflammation from immunotherapy.
What could go wrong
This is a large phase 3 trial, but abatacept may not reduce heart complications more than standard care. Risks include potential infections or allergic reactions from the drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 390 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 legally authorized representative may consent on behalf of the study participant, as permitted by local law and institutional Standard Operating Procedures; 2. Aged greater than or equal to 18 years at the time of informed consent; 3. 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; 4. A diagnosis of myocarditis. 5. Hospitalized at the time of randomization; 6. On 1000 mg of solumedrol per day for myocarditis or with an intent to initiate 1000 mg of solumedrol per day for myocarditis within 24 hours of first administration of study drug; 7. Serum evidence of ongoing myocardial injury: Serum evidence of ongoing myocardial injury will be defined as an institutional troponin (either conventional or high-sensitivity troponin I or T, using the standard institutional assay) with a value that is ≥5 times the upper limit of the reference standard normal for that institution. The troponin assay may be adjusted based on sex depending on institutional standards. This value of troponin of ≥5 times above the institutional upper limits of normal value must be noted within 10 days prior to potential randomization. The 10-day period can be in the outpatient or inpatient setting. For example, a participant with a troponin value that on one occasion was ≥5 times the upper limits of institutional normal in the 10-day window prior to potential randomization (whether in the inpatient or outpatient setting), but later decreases below that threshold, typically due to starting corticosteroids, would still be considered eligible; 8. The following laboratory parameters, not older than 48 hours at the time of randomization, and measured as part of usual care: * Total white blood cell (WBC) count \>2,500/μl * Absolute neutrophil count (ANC) \>1,500/μL * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<20 times the upper limit of the institutional normal ranges; 9. Women of childbearing potential (i.e., not postmenopausal, or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test prior to randomization. Participating women of childbearing potential must be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug. Participating men must also be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug; and 10. Must be willing and able to abide by all study requirements and restrictions. Exclusion Criteria: 1. Must not have experienced any of the following (as defined in the section on the primary endpoint) in the 30-day period prior to randomization: * 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. 2. Recent (≤2 month) exposure to abatacept or belatacept. 3. 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. 4. Currently enrolled in another interventional study utilizing systemic agents for the management of ICI-related toxicities. 5. Female who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 90 days after the last dose of study drug. 6. Male who is considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug. 7. Any active, chronic, or recurrent viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study. These may include hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, and disseminated (even a single episode) herpes simplex. Active HBV and HCV are defined as: HBV: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for Hepatitis B core antibody (HBc Ab) positive (+) participants; HCV: HCV ribonucleic acid (RNA) detectable in any participant with anti-HCV antibody (HCV Ab). Patients with active Covid-19 infection will be excluded. This is defined as the period of ongoing symptoms in the setting of a positive Covid-19 test, or until 10 days after symptom onset and after resolution of fever for at least 24 hours, without the use of fever-reducing medications. 8. Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections; 9. Receipt of any live vaccine within four weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 90 days after the last dose of IV study drug. 10. Any medical condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study. 11. Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

acute myocarditis cancer myocarditis neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer Myocarditis acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny-Singer Research Institution

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Aurora St Luke's Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 02127, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Franciscan Health

    RECRUITING

    Indianapolis, Indiana, 46237, United States

  • Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Lehigh Valley Health Network

    RECRUITING

    Bethlehem, Pennsylvania, 18017, United States

  • MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Maine Health

    RECRUITING

    Portland, Maine, 04102, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • McMaster University

    RECRUITING

    Hamilton, Ontario, L8V 1C3, Canada

  • MedStar Health Research Institute, Georgetown University

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • University of British Colombia

    RECRUITING

    Vancouver, British Colombia, V5Z 1M9, Canada

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536-0200, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599-7075, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 72535, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of West Virginia

    RECRUITING

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.