Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients 18 years of age, or older, with skin cancer and eligible for ICI treatment with a combination of a) nivolumab, b) pembrolizumab, or c) ipilimumab.
Able to provide informed consent
Able to travel to SHSC for cardiac imaging.
Disqualifiers
Life expectancy equal to, or less than, 12 months
Participating in another clinical trial
Treated with ICI in the past
History of cardiac disease (e.g. heart failure, myocardial infarction, atrial fibrillation, unstable angina)
Trial population
This pilot study will include 15 patients recruited from Odette Cancer Centre at Sunnybrook Health Sciences Center who have skin cancer and are eligible for immunotherapy treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
15 Participants
are grouped into 1 trial groupGroup A: Patients with skin cancer eligible for dual ICI treatment.
Trial outcomes
Primary outcomes
1
Define changes in CMR tissue and blood biomarkers during ICI treatment.
The following parameters are investigated to assess for underlying myocardial remodelling and/or inflammation during treatment with ICI. Left ventricular volumes in ml Left ventricular ejection fraction in percentage T1 Mapping: T1 relaxation time in milliseconds T2 Mapping: T2 relaxation time in milliseconds ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)) in percentage Strain (GCS, GLS, GRS) reported as a percentage, formula =(Max Length-Initial Length)/Initial Length LGE is qualitatively described as categorical variables e.g. epicardial, mid-myocardial, subendocardial or transmural. LGE is quantified as mass in gram and as percentage of the LV mass. High sensitivity troponin 1 nanogram/ mL B-type natriuretic peptide (BNP) nanogram/L High sensitivity CRP in mg/L
Time frame
Baseline, 6 weeks and 6 months2
Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction.
This analysis is to determine if the biomarkers are associated with LVEF changes over time. Left ventricular volumes in ml Left ventricular ejection fraction in percentage T1 Mapping: T1 relaxation time in milliseconds T2 Mapping: T2 relaxation time in milliseconds ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)) in percentage Strain (GCS, GLS, GRS) reported as a percentage, formula =(Max Length-Initial Length)/Initial Length LGE is qualitatively described as categorical variables e.g. epicardial, mid-myocardial, subendocardial or transmural. LGE is quantified as mass in gram and as percentage of the LV mass.
Time frame
Baseline, 6 weeks and 6 months3
Investigate associations between serum biomarkers and CMR-defined left ventricular ejection fraction.
This analysis is to determine if blood biomarkers are associated with LVEF changes over time. High sensitivity troponin 1 nanogram/ mL B-type natriuretic peptide (BNP) nanogram/L High sensitivity CRP in mg/L
Time frame
Baseline, 6 weeks and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov