Aggressive lipid lowering in melanoma patients starting immune checkpoint therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Melanoma patients who are new to immune checkpoint inhibitors undergo a coronary CT angiography to assess heart artery health. Images are analyzed with a FDA-approved image tool to identify plaques. Those with heart artery disease are randomized to usual care or aggressive lipid lowering therapy, managed by a cardiologist, with a goal LDL cholesterol of 55 mg/dL; follow-ups include repeat imaging at 12 and 24 months. The main outcome is the difference in LDL-C between groups at 12 months, with secondary outcomes including other cardiovascular measures. Interventions may include statins, ezetimibe, and/or PCSK9 inhibitors.

Why it matters

Who can join: the full rules

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 or report of menopausal status via approximate last menstrual period or hysterectomy due to contraindication of pregnancy for the CCTA procedure. Those without documentation or report of menopausal status require a negative urine pregnancy test (serum pregnancy test will only be done if needed to confirm an ambiguous or positive urine test).
* 5\. Have a melanoma diagnosis without prior course(s) of ICI use and planning to start (or currently on) first course of ICI therapy (PD-1, PD-L1, CTLA-4, LAG3). ICI start can occur prior to consent (up to 90 days prior to eligibility CCTA) as long as it is first exposure. ICI therapy can be received as standard of care or other trial treatment 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 prior to signing the consent form or at screening) 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 prior to signing the consent form or at screening.
* 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. A current value must be collected within 90 days prior to signing the consent form or at screening.
* 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.

Where it's running

• University of Colorado Hospital
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Caitlin Bell, MD — University of Colorado, Denver
• Study coordinator: Zackry Morgan
• Email: zackry.morgan@cuanschutz.edu
• Phone: 720-848-5494

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.