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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: Recruiting Phase 3 study of Cancer and Myocarditis Acute, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The rates of a composite of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, 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
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2022-07-02 |
| Est. Completion | 2027-04-20 |
| Phase | Phase 3 |
What NCT05335928 shows while recruiting
NCT05335928 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 3,490-participant average among 615 other Cancer trials with a reported enrollment target (89% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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Where NCT05335928's enrollment target sits among peer trials
390 153rd of 615 higher than 462 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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