NCT07704918 · University of Colorado, Denver
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
What this study is about
Immune checkpoint inhibitors (ICIs) are a class of medications that are now standard in the treatment of melanoma. These are standard therapy for melanoma, but long-term side effects on disease in the heart arteries is poorly understood. In this study, melanoma patients receiving ICIs for the first time will undergo a coronary computed tomography angiography (CCTA) scan.
View original scientific description
Immune checkpoint inhibitors (ICIs) are a class of medications that are now standard in the treatment of melanoma. These are standard therapy for melanoma, but long-term side effects on disease in the heart arteries is poorly understood. In this study, melanoma patients receiving ICIs for the first time will undergo a coronary computed tomography angiography (CCTA) scan. CCTA results will be analyzed by the FDA-approved Cleerly TM image analysis pipeline. Patients with disease in their heart arteries will be randomized to usual care or aggressive lipid lowering therapy. Those in the aggressive lipid lowering therapy arm will be seen by a cardiologist and placed on standard lipid lowering medications with a goal of achieving an LDL-C ≤ 55mg/dL. Follow-up CCTA scans will occur at 12-month and 24-month timepoints. The primary outcome of interest will be differences in LDL-C levels between the two arms at the 12-month timepoint. The secondary outcome of interest will be the differences in total plaque volume between the two arms at the 12-month timepoint.
Interventions
DRUG
Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)
Participants randomized to the aggressive lipid lowering therapy arm will receive Guideline-directed lipid-lowering therapy (statins and/or ezetimibe and/or PCSK9 inhibitors) managed by a cardiologist with dose adjustments to achieve LDL-C ≤55 mg/dL.
Primary outcome measures
Mean change in LDL-C from baseline to 12 months
Time frame: Baseline 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Aurora, Colorado
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2026 · Source of record for eligibility and locations