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Study on Atorvastatin to Prevent Atherosclerosis Progression in Patients Undergoing Immune Checkpoint Inhibitor Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication atorvastatin on a condition called atherosclerosis. Atherosclerosis is a disease where the arteries become narrowed and hardened due to a buildup of plaque, which can lead to serious heart problems. The trial aims to see if atorvastatin can help prevent the worsening of atherosclerosis in patients who are receiving a type of cancer treatment known as immune checkpoint inhibitors (ICIs). These ICIs include medications like nivolumab, pembrolizumab, and ipilimumab, which are used to treat melanoma, a type of skin cancer.

Participants in the study will be divided into two groups. One group will receive atorvastatin, a cholesterol-lowering medication, while the other group will receive a placebo. The study will last for about a year, and during this time, researchers will monitor changes in the participants' arteries to see if atorvastatin can slow down the progression of atherosclerosis compared to the placebo. The main focus will be on the arteries in the chest area, specifically the descending thoracic aorta.

Throughout the study, researchers will also look at other factors, such as changes in the heart's arteries and overall heart health, as well as any side effects experienced by participants. The goal is to gather information on whether atorvastatin can be beneficial for patients undergoing ICI therapy by potentially reducing the risk of heart-related issues associated with atherosclerosis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will need to provide informed consent, confirming that you understand the study and agree to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes checking for the presence of atherosclerosis in the thoracic aorta, which is a condition where the arteries become narrowed and hardened due to a buildup of plaque.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either atorvastatin or a placebo. Atorvastatin is a medication used to lower cholesterol and reduce the risk of heart disease. A placebo is a substance with no active therapeutic effect, used as a control in testing new drugs.

    The medication will be taken orally. The dosage and frequency will be provided by the study team, and you will be required to follow these instructions carefully throughout the trial.

  4. Step 4

    Ongoing assessments

    Throughout the trial, regular assessments will be conducted to monitor your health and the progression of atherosclerosis. These assessments will include imaging tests to measure changes in plaque volume in your arteries.

    You will also be asked to report any side effects or changes in your health to the study team.

  5. Step 5

    Quality of life evaluations

    Your quality of life will be evaluated at the start of the trial, and then again at 3 months, 6 months, and 1 year after beginning the ICI therapy (immune checkpoint inhibitor therapy). This therapy is a type of cancer treatment that helps the immune system fight cancer.

  6. Step 6

    Completion of the trial

    The trial will conclude after one year of participation. At this point, a final assessment will be conducted to evaluate the overall effects of the medication on your atherosclerosis and quality of life.

Who can join the trial?

6 criteria

  • Patients with melanoma who are scheduled to receive ICI therapy (nivolumab, pembrolizumab, ipilimumab, or combination therapy) according to standard care. ICI therapy refers to immune checkpoint inhibitors, which are drugs that help the immune system fight cancer.
  • Age 18 years or older.
  • Able to understand the written information and able to give informed consent. This means you can read and understand the details of the study and agree to participate.
  • Presence of thoracic aortic atherosclerosis at baseline. This means there are signs of atherosclerosis in the thoracic aorta, which is a part of the main artery in the chest. This can include:
    • Calcifications in the vessel wall of the thoracic aorta. Calcifications are calcium deposits that can harden the arteries.
    • Irregularity of the vessel wall in the thoracic aorta.
    • Thickening of the vessel wall with a hypodense aspect in the thoracic aorta. Hypodense means the area appears less dense on imaging tests.

Who cannot join the trial?

8 criteria

  • Patients with a history of **allergic reactions** to atorvastatin or similar medications cannot participate. An allergic reaction is when your body has a bad response to a substance.
  • Patients who are currently taking medications that interact negatively with atorvastatin are excluded. This means if you are on certain drugs that do not work well with atorvastatin, you cannot join.
  • Patients with **liver disease** are not allowed to participate. Liver disease affects how your liver works, which is important for processing medications.
  • Patients with **kidney disease** are excluded. Kidney disease affects how your kidneys function, which can impact how drugs are removed from your body.
  • Women who are pregnant or breastfeeding cannot take part in the study. This is to ensure the safety of the mother and child.
  • Patients with **uncontrolled diabetes** are not eligible. Uncontrolled diabetes means your blood sugar levels are not stable.
  • Patients with a history of **muscle disorders** related to statin use are excluded. Muscle disorders can cause pain or weakness.
  • Patients who have participated in another clinical trial within the last 30 days cannot join. This is to avoid any interference from other treatments.
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Investigated drugs

Atorvastatin is a medication that is commonly used to lower cholesterol levels in the blood. It works by blocking a substance your body needs to make cholesterol, which can help prevent heart disease and stroke. In this clinical trial, atorvastatin is being studied to see if it can prevent the worsening of atherosclerosis, a condition where the arteries become narrowed and hardened due to a buildup of plaque, during treatment with immune checkpoint inhibitors (ICI). The goal is to see if atorvastatin can help keep the arteries healthier in patients receiving ICI therapy.

What is already known about the treatment

Atorvastatin – Atorvastatin is a medication taken orally, usually in the form of a tablet, and is used to help manage cholesterol levels in the body. It is currently well-established in medical practice and literature as a treatment for high cholesterol and is being studied for its potential to prevent the progression of atherosclerosis, especially in patients undergoing immune checkpoint inhibitor therapy. The main therapeutic use of atorvastatin is to lower bad cholesterol (LDL) and triglycerides in the blood while increasing good cholesterol (HDL). At the molecular level, it works by inhibiting an enzyme in the liver that is responsible for producing cholesterol, thereby reducing overall cholesterol levels. Atorvastatin belongs to a class of drugs known as statins, which are widely used to prevent cardiovascular diseases.

Investigated diseases

Atherosclerosis – Atherosclerosis is a condition where the arteries become narrowed and hardened due to a buildup of plaque on the artery walls. This plaque is made up of fat, cholesterol, calcium, and other substances found in the blood. Over time, the plaque can harden and narrow the arteries, limiting the flow of oxygen-rich blood to organs and other parts of the body. As the disease progresses, it can lead to reduced blood flow, which may cause symptoms like chest pain or leg pain during physical activity. In advanced stages, atherosclerosis can lead to serious complications if the blood supply to the heart or brain is significantly reduced. The progression of the disease can vary, and it often develops slowly over many years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511127-33-00Estimated enrolment172 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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