Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma

Inclusion criteria

• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Be a male aged ≥55 years or a female aged ≥65 years.
• For those able to bear children, documentation of menopausal status via approximate last menstrual period or hysterectomy due to contraindication of pregnancy for the CCTA procedure.
• Have a melanoma diagnosis without prior ICI use and planning to start on ICI therapy (PD-1, PD-L1, CTLA-4, LAG3) as standard of care for their cancer.
• Plaque stage ≥ 1 on screening CCTA.

Exclusion criteria

• Any prior major cardiovascular event, defined as myocardial infarction, stroke, coronary revascularization, or other major cardiovascular event determined to be significant by the principal investigator.
• Meeting any of the standard CCTA contraindications listed below:
• Allergy to iodinated contrast or history of contrast-induced nephropathy
• Renal insufficiency (eGFR < 45 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation). A current eGFR value (collected/calculated within 3 months from screening visit) is required at baseline.
• Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., > 80 beats per minute). EKG must be performed within 1 year of screening visit.
• Hemodynamic instability
• Weight > 400 lbs. (181 kg) or above manufacturer-recommended limit for scanner and table, whichever is lower
• Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment
• Pregnancy
• Inability to hold breath for > 10 seconds
• Contraindication to dosing with beta blocker as needed or nitroglycerin prior to CCTA procedure
• Inability to cooperate with scan acquisition and/or breath-hold instructions
• Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA
• If a patient's fast LDL-C is > 190 mg/dL, this is consistent with underlying familial hypercholesterolemia, and they will not be eligible for the study.
• If a patient's CCTA demonstrates previously undiagnosed obstructive coronary disease, they will not be eligible for the study. Obstructive disease will be defined as >50% obstruction in the left main coronary artery, or >70% obstruction elsewhere in the coronary tree.