Can cholesterol drugs shield the heart during melanoma immunotherapy?
NCT ID NCT07704918
First seen Jul 15, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study investigates whether aggressive lipid-lowering therapy can reduce plaque buildup in the heart arteries of melanoma patients starting immune checkpoint inhibitors (ICIs). Participants with plaque detected on a heart CT scan are randomly assigned to either usual care or aggressive treatment with statins and other cholesterol-lowering drugs, aiming for very low LDL levels. The trial tracks changes in LDL cholesterol and plaque volume over 12 months to see if this approach protects heart health during cancer treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)
- What this could lead to
- If successful, this could show that aggressive cholesterol-lowering therapy protects the heart arteries of melanoma patients treated with immune checkpoint inhibitors.
- What could go wrong
- This is a small, early-phase study with only 40 participants, so results may not apply broadly. The aggressive therapy may cause side effects like muscle pain or liver issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Colorado Hospital
RECRUITINGAurora, Colorado, 80045, United States
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Other studies related to the condition(s) this trial covers.
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- Blood test could spot Melanoma's BRAF mutation
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?
- Can a Two-Drug immune combo shrink melanoma tumors?