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Aggressive Lipid Lowering Therapy in Melanoma Patients on Immunotherapy

This study is looking at how aggressive lipid-lowering therapy affects heart artery health in people with melanoma who are starting immune checkpoint inhibitors (ICIs) for the first time. ICIs are standard melanoma treatments, but their long-term effects on heart arteries are not fully understood. You would have a special heart scan (coronary computed tomography angiography, CCTA). If the scan shows disease in your heart arteries, you would be randomly assigned to either usual care or an aggressive lipid-lowering therapy. This therapy involves statins (like atorvastatin, rosuvastatin, simvastatin, or pravastatin), possibly with ezetimibe or PCSK9 inhibitors (alirocumab, evolocumab, inclisiran), managed by a heart doctor to achieve very low LDL-C levels (bad cholesterol). The main goal is to see the change in LDL-C over 12 months. This study is for people aged 55 or older.

Study design
This is an interventional study planning to enroll 40 participants. Participants with heart artery disease will be randomly assigned to either usual care or aggressive lipid-lowering therapy.
What's involved
You would undergo a coronary computed tomography angiography (CCTA) scan. If eligible, you would receive either usual care or lipid-lowering medications managed by a cardiologist.
Compensation
Not stated in the trial record.
Follow-up
The main measurement for this study is taken at 12 months after baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07704918

Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma

Not Yet Recruiting
NAAges 55+InterventionalTreatment
University of Colorado, Denver
~40 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in LDL-C from baseline to 12 months
Measured over Baseline to 12 months

Conditions

Melanoma

Explore related trials

AtherosclerosisCoronary Artery DiseaseCoronary AtherosclerosisMelanoma

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Caitlin Bell, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Zackry Morgan
[email protected]
720-848-5494
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Mean change in LDL-C from baseline to 12 monthsBaseline to 12 months

    Each participant will have LDL-C measured prior to randomization and at the 12-month timepoint. The mean change in LDL-C (mg/dL) from baseline to 12 months will be calculated for each participant. The mean change will be compared between the aggressive lipid-lowering therapy arm and the usual care arm.