Immune Checkpoint Therapy
Conditions
Brief summary
To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects.
Detailed description
Primary Objectives: * Myocarditis CTCAE version 5.0 grade ≥ 3 * Ventricular tachycardia (≥ 30 seconds) * Advanced atrioventricular block * Incident heart failure event * Cardiovascular mortality * Non-fatal sudden cardiac arrest * Acute coronary syndrome * Pericarditis * Pericardial tamponade Secondary Objectives: * Time from symptom onset to diagnosis of major adverse cardiovascular events * Time from symptom onset to diagnosis of myocarditis * Initial hospitalization duration for the adverse cardiovascular event from primary endpoint * Peak biomarker levels including troponin T, troponin I, creatine kinase, and creatine kinase myocardial band * Percentage of patients with negative workup for myocarditis * Percentage of patients requiring major cardiac testing including echocardiograms, cardiac magnetic resonance imaging, and/or invasive heart catheterization * Duration of interruption and/or discontinuation of immune checkpoint inhibitor therapy * Cancer progression free survival * Time to next cancer therapy
Interventions
DIAGNOSTIC_TESTTroponin surveillance
Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.
OTHERStandard of care
Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient ≥18 years old * Plan for treatment with an immune checkpoint inhibitor as standard of care even if patient is also on an additional investigational cancer therapeutic * Willingness to provide informed consent
Exclusion criteria
* Troponin T not available at screening or prior to randomization * Inability to comply with planned study procedures * Major adverse cardiovascular event included in the primary outcome within the 30 days prior to enrollment * 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 * Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events (AEs) | Through study completion; an average of 1 year. | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) |
Countries
United States
Contacts
CONTACTNicolas Palaskas, MD
PRINCIPAL_INVESTIGATORNicolas Palaskas, MD
M.D. Anderson Cancer Center
Outcome results
None listed