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NCT07704918Recruiting

Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma

Lipid Lowering Therapy for Atherosclerotic Disease in Melanoma Patients Receiving Immune Checkpoint Inhibitors

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
2 Jul 2026
Start date
19 Oct 2026
Primary completion date
Dec 2027
Lead sponsor
University of Colorado, Denver
NCT number
NCT07704918

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 19 Oct 2026 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.
  • Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment
  • Contraindication to dosing with beta blocker as needed or nitroglycerin prior to CCTA procedure
  • 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.

Other illness

  • Allergy to iodinated contrast or history of contrast-induced nephropathy

Lab values

  • 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.
  • 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.

Other

  • Meeting any of the standard CCTA contraindications listed below:
  • Hemodynamic instability
  • Weight \> 400 lbs. (181 kg) or above manufacturer-recommended limit for scanner and table, whichever is lower
  • Pregnancy
  • Inability to hold breath for \> 10 seconds
  • 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

Who the study is looking for

  • 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.

Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado Hospital
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.