ATROPOS: Survival analysis of immune checkpoint inhibitor–associated myocarditis
Official title: ATROPOS: Assessing morTality and Risk factOrs in Immune checkPoint Inhibitor-induced myotOxicities: a Survival Analysis Based on an International Registry
Run by Groupe Hospitalier Pitie-Salpetriere · NCT07633587 · Data updated 2026-11-12
We’re testing whether different steroid-first and second-line immunosuppressant treatments affect survival in cancer patients who develop myocarditis from immune checkpoint inhibitors.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Groupe Hospitalier Pitie-Salpetriere Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | May 20, 2026 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2027 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07633587 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with cancer treated with immune checkpoint inhibitors who have possible, probable, or definite ICI-associated myocarditis recorded in the international registry.
✕Probably not a fit
Patients whose myocarditis is not related to ICI exposure or who do not receive any form of immunosuppressive therapy may see no benefit from these findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
ATROPOS is an international, registry-based observational study of cancer patients with ICI-associated myocarditis. It uses the REDCap registry to examine how initial glucocorticoids and subsequent second-line immunosuppressants relate to overall mortality, with analysis adjusted for severity and other clinical factors. The study plans to include up to 1,500 cases from at least 160 centers across 18 countries, using time-dependent survival models where appropriate. Secondary analyses will look at mortality at 30, 90, and 360 days and cause-specific death when data are available. Descriptive statistics and Cox models will adjust for oncology history, ICI exposure, cardiac imaging and biomarker data, and other risk factors.
Why it matters
Potential benefit: If successful, findings could guide smarter, personalized treatment strategies to improve survival for patients with ICI-associated myocarditis.
How similar studies have gone: Other observational studies in this area have shown signals that treatment strategies may influence outcomes, but robust, large-scale analyses are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * cancer patients exposed to at least one immune checkpoint inhibitor * possible, probable or definite immune checkpoint inhibitor-associated myocarditis recorded in the international registry according to registry/adjudication definitions * available index-date/presentation information * available mortality follow-up. Exclusion Criteria: * duplicate records * not enough data to classify as myocarditis * record/patient withdrawn from research use unresolved data-quality issues preventing inclusion in the final SAP-defined analysis set.
Where it's running
-
Hopital Pitie-Salpetriere / CIC-2503
Paris, France Recruiting
Study contacts
- Study coordinator: Joe-Elie Salem, MD-PhD
- Email: joe-elie.salem@aphp.fr
- Phone: 0033142178531
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.