Recruiting

ICIs with Lipid Therapy

Sponsor:

University of Colorado, Denver

Code:

NCT07704918

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)

Study Details

Brief 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. 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

Study ID

NCT07704918

Start date

Dec 31, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Active Comparator: Usual Care

Active Comparator: Usual Care: 12- and 24-month follow-up CCTA with plaque staging, lipid panel

experimental: Aggressive Lipid Lowering Therapy

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.

Interventions

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 measure

  • Mean change in LDL-C from baseline to 12 months [ Time Frame: Baseline to 12 months ]

Central Contacts and Locations

Central contacts

Zackry Morgan

720-848-5494zackry.morgan@cuanschutz.edu

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Zackry Morgan

720-848-5494zackry.morgan@cuanschutz.edu

Principal Investigator:

Caitlin Bell, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • atherosclerosis
  • coronary artery disease
  • coronary atherosclerosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-08-07.