Recruiting

Immune Checkpoint Inhibitor

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06309862

Conditions

Cardio-Oncology

Cardiomyopathy Due to Drug

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Cardio-Oncology

Cardiomyopathy Due to Drug

Study ID

NCT06309862

Start date

Jun 1, 2024

Status verified date

Jun, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with skin cancer eligible for dual ICI treatment.

Primary outcome measure

  • Define changes in CMR tissue and blood biomarkers during ICI treatment. [ Time Frame: Baseline, 6 weeks and 6 months ]
  • Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction. [ Time Frame: Baseline, 6 weeks and 6 months ]
  • Investigate associations between serum biomarkers and CMR-defined left ventricular ejection fraction. [ Time Frame: Baseline, 6 weeks and 6 months ]

Central Contacts and Locations

Central contacts

Christian Houbois, MD

(416) 480-6100christian.houbois@sunnybrook.ca

Navpreet Sekhon, MB Bch BAO

(416) 480-6100navpreet.sekhon@sri.utoronto.ca

Locations

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Thayalasuthan Vivekanandan, MD

(416) 480-6100thayalasuthan.vivekanandan@Sunnybrook.ca

Navpreet Sekhon, MB Bch BAO

(416) 480-6100navpreet.sekhon@sri.utoronto.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jun 7, 2024

Last verified

Jun, 2024

Keywords

  • Cardio-Oncology
  • Immunotherapy
  • Cardiomyopathy
  • Cardiac MRI
  • Myocardial tissue changes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-06-07.