Abatacept for immune checkpoint inhibitor associated myocarditis (ATRIUM): Phase 3, investigator-initiated, randomized, placebo-controlled study to evaluate the efficacy and safety of abatacept compared to placebo in hospitalized patients with immune checkpoint inhibitor associated myocarditis.
Bibliographic record
Abstract
TPS2680 Background: Patients with myocarditis secondary to treatment with an immune checkpoint inhibitor (ICI) represent a poor prognosis population with a critical unmet clinical need. Data have shown that the rate of major adverse cardiac events (MACE) with ICI myocarditis despite administration of corticosteroids ranges from 25-50%. Abatacept is a selective co-stimulation modulator that inhibits T cell activation by binding to CD80 and CD86, thereby blocking its interaction with CD28. In preclinical animal models of ICI myocarditis, the administration of abatacept led to a reduction in cardiac immune activation and an increase in survival. Methods: The abatacept for immune checkpoint inhibitor associated myocarditis (ATRIUM) trial is designed as a phase 3, investigator-initiated, randomized, placebo-controlled study to evaluate the efficacy and safety of abatacept compared to placebo in hospitalized participants with ICI associated myocarditis. Hospitalized participants diagnosed with ICI-related myocarditis, as defined by the International Cardio-Oncology Society, ≥ 18, with serum evidence of ongoing myocardial injury (troponin ≥5 times the upper limit normal), and treated, or with intent to treat, with 1000 mg of solumedrol/day are eligible. In the randomized protocol, participants receive either abatacept (10 mg/kg) or placebo given IV followed by study drug infusion/placebo again at 24 hours and on day 14. Of note, there is an optional 4th dose on day 28. The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in MACE among participants hospitalized with myocarditis secondary to an ICI. The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure. Each component of the primary composite end point will be evaluated individually as a secondary endpoint, as are troponin levels, rates of deep venous thrombosis and pulmonary embolism, and incidence rates of treatment-related adverse events. Exploratory outcomes focus on cancer outcomes, healthcare utilization, quality of life, and correlative studies. Recently, the trial has been amended to allow eligible participants who have achieved an ATRIUM primary end-point prior to randomization to be eligible for inclusion in the RESCUE arm of the protocol where they will be given open-label Abatacept on day 1, 2, 14, with optional dose at 28. The study is open at 20 sites across the US with a plan for a total of 50 locations across US and Canada. This study is recruiting at time of submission. Target enrollment is 390 patients. Clinical trial information: NCT05335928 .
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".