Melanoma study: Statins
Official title Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
ClinicalTrials.gov ID: NCT07704918
What this study is testing
What is Aggressive lipid lowering therapy (statins, ezetimibe, PCSK9 inhibitor)?
An investigational combination of lipid‑lowering drugs being studied as a potential way to reduce heart‑artery plaque in melanoma patients receiving immune checkpoint inhibitors. is designed to lower LDL‑cholesterol by inhibiting cholesterol synthesis (statins), blocking intestinal cholesterol absorption (ezetimibe), or increasing LDL‑receptor activity (PCSK9 inhibitors).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if intensive lipid‑lowering treatment can lower LDL cholesterol and reduce artery plaque in these patients.
- Who it's for
- Adults with melanoma who are beginning immune checkpoint inhibitor therapy and have artery disease shown on a heart CT scan.
- What's involved
- Participants get a coronary CT scan, then those with plaque are randomly assigned to usual care or to cholesterol‑lowering medicines aimed at LDL ≤55 mg/dL, with cardiology follow‑up and repeat scans.
- Time commitment
- The trial lasts about two years, with visits and scans at baseline, 12 months, and 24 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Any prior major cardiovascular event, defined as myocardial infarction, stroke, coronary revascularization, or other major cardiovascular event...
- 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...
- Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \>...
- Hemodynamic instability
- Weight \> 400 lbs. (181 kg) or above manufacturer-recommended limit for scanner and table, whichever is lower
See the full eligibility 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 or report of menopausal status via approximate last menstrual period or hysterectomy due to contraindication of pregnancy for the CCTA procedure.
- 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).
- Plaque stage ≥ 1 on screening CCTA.
- 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.
- 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).
- Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \> 80 beats per minute).
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.