MelanomaNCT07704918
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
A study testing Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran) in people with Melanoma, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Zackry Morgan, 720-848-5494, zackry.morgan@cuanschutz.edu
Caitlin Bell, MD
About this study
Official title: Lipid Lowering Therapy for Atherosclerotic Disease in Melanoma Patients Receiving Immune Checkpoint Inhibitors
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.
- Conditions
- Melanoma
- Being tested
- Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)
- Keywords
- atherosclerosis, coronary artery disease, coronary atherosclerosis
- Medical subject headings
- Melanoma, Atherosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Usual Care | No intervention | Active Comparator: Usual Care: 12- and 24-month follow-up CCTA with plaque staging, lipid panel |
| Aggressive Lipid Lowering Therapy | Experimental | Participants in the 'aggressive lipid lowering therapy' arm will receive guideline-directed lipid lowering therapy (statins and/or PCSK9 inhibitors) managed by a cardiologist. Dosing adjustments will be guided by individual patient response and standard-of-care practices, with the goal of achieving LDL-C ≤55 mg/dL. Receives: Drug: Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in LDL-C from 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.
Measured: Baseline to 12 months
Secondary outcomes (4)
Change in Total Plaque Volume from Baseline to 12 months
Each participant will have total plaque volume measured prior to randomization and at the 12-month timepoint via Cleerly TM's CCTA image analysis pipeline. The mean change in total coronary plaque volume (mm³), as measured by coronary computed tomography angiography (CCTA) using the Cleerly™ image analysis pipeline, from baseline to 12 months will be calculated for each participant and compared between study arms.
Measured: 12 months
Major adverse cardiovascular events at 12 months
Major adverse cardiovascular events between 0 and 12 months will be noted to determine if there is a difference in major adverse cardiovascular events (MACE) rates between the usual care arm versus the aggressive lipid lowering arm.
Measured: 12 months
Change in Calcified Plaque Volume from Baseline to 12 Months
Each participant will have proportion of calcified plaque volume measured prior to randomization and at the 12-month timepoint via Cleerly TM's CCTA image analysis pipeline. The difference between these two timepoints in each participant will be calculated to determine if there is a significant difference between proportion of calcified plaque volume changes in the usual care arm versus the aggressive lipid lowering arm.
Measured: 12 months
Change in Size of the Largest Plaque from Baseline to 12 Months
Each participant will have the size of the largest plaque (by volume) measured prior to randomization and at the 12-month timepoint via Cleerly TM's CCTA image analysis pipeline. The difference between these two timepoints in each participant will be calculated to determine if there is a significant difference between largest plaque volume changes in the usual care arm versus the aggressive lipid lowering arm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start19 Oct 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caitlin Bell, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704918
- Sponsor's protocol ID
- 25-1921.cc
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No