Investigating heart risks in cancer patients receiving immune therapy
Association of Immune Checkpoint Inhibitor Therapy for Cancer With Early Myocardial Tissue and Biomarker Changes During Treatment - Implication for Risk of Myocarditis and Cardiomyopathy
This study is testing whether immune therapy for skin cancer can lead to heart problems, like myocarditis or cardiomyopathy, by using heart scans to monitor any changes in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | nivolumab, pembrolizumab, ipilimumab |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06309862 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with skin cancer who are undergoing treatment with immune checkpoint inhibitors (ICI) such as nivolumab, pembrolizumab, or ipilimumab. It aims to assess the risk of developing myocarditis and cardiomyopathy during treatment, utilizing cardiac MRI to monitor myocardial tissue changes. By identifying these changes early, the study seeks to improve patient outcomes and prevent severe cardiac events associated with ICI therapy. The research addresses a critical gap in the field of Cardio-Oncology as cancer therapies evolve.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with skin cancer who are eligible for ICI treatment.
Not a fit: Patients with a history of significant cardiac disease or those who have previously received ICI treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and prevention of serious heart complications in cancer patients receiving immune therapy.
How similar studies have performed: While there is limited data on this specific approach, the use of cardiac MRI in monitoring heart conditions in cancer patients is gaining traction, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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) * Pregnant patients * Impaired renal function (GFR equal to, or less than, 30mL/min) * Contraindications for MRI (e.g. pacemaker).
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Christian Houbois, MD — Sunnybrook Health Sciences Centre
- Study coordinator: Christian Houbois, MD
- Email: christian.houbois@sunnybrook.ca
- Phone: (416) 480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.