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NCT05335928 · ClinicalTrials.gov registry record · Phase 3

Abatacept in Immune Checkpoint Inhibitor Myocarditis

A Phase 3 study of Cancer and Myocarditis Acute, sponsored by Massachusetts General Hospital.

Recruiting
Registry status
Phase 3
Development phase
390
Enrollment target
20
Study locations

NCT05335928 is a Phase 3 study of Cancer and Myocarditis Acute that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 390 participants, below the 3,490-participant average among 615 other Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT05335928, a Phase 3 study of Cancer and Myocarditis Acute, is actively recruiting participants, sponsored by Massachusetts General Hospital.

RECRUITING
Registry status
Phase 3
Development phase
390 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Abatacept plus

Study Locations (20)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Boston Medical Center - Boston
  • Brigham and Women's Hospital - Boston

California

  • Cedars-Sinai Medical Center - Los Angeles
  • University of California Los Angeles - Los Angeles

New York

  • Columbia University Irving Medical Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

District of Columbia

  • MedStar Health Research Institute, Georgetown University - Washington D.C.

Florida

  • Moffitt Cancer Center - Tampa

Illinois

  • University of Chicago - Chicago

Indiana

  • Franciscan Health - Indianapolis

Kansas

  • University of Kansas Medical Center - Kansas City

Trial Details

FieldValue
Enrollment Target 390 participants
Start Date 2022-07-02
Est. Completion 2027-04-20
Phase Phase 3

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT05335928

The ClinicalTrials.gov registry entry for NCT05335928 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,490-participant average among 615 other Cancer trials with a reported enrollment target (89% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05335928 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Massachusetts, California, New York.

Frequently Asked Questions

What is clinical trial NCT05335928 about?

NCT05335928 is a clinical study titled "Abatacept in Immune Checkpoint Inhibitor Myocarditis". 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 occurrenc...

What is the current status of trial NCT05335928?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2022-07-02. Estimated completion is 2027-04-20.

What conditions does trial NCT05335928 study?

This clinical trial studies the following conditions: Cancer, Myocarditis Acute.

What interventions are being tested in trial NCT05335928?

The interventions under investigation include: Placebo (DRUG), Abatacept plus (DRUG).

Who is sponsoring clinical trial NCT05335928?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05335928 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.