Tests atorvastatin to prevent plaque buildup in melanoma patients on immunotherapy
Tests atorvastatin against placebo in adults with melanoma receiving immune checkpoint therapy.
Plain-language title generated from the registry record
Registry title: Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis
Key facts
- Where
- Rotterdam, NetherlandsSee the site
- Phase
- Phase 4
Where in Netherlands
- Erasmus Universitair Medisch Cetrum RotterdamRotterdam, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Medical Center
- Trial code
- NCT06785974
- Record updated
- 22 January 2025
- Original description
The goal of this interventional study is to test whether atorvastatin prevents accelerated progression of atherosclerosis in melanoma patients who receive immune checkpoint inhibitor (ICI) therapy. The main questions it aims to answer are:Read full original descriptionShow less
Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis
The goal of this interventional study is to test whether atorvastatin prevents accelerated progression of atherosclerosis in melanoma patients who receive immune checkpoint inhibitor (ICI) therapy. The main questions it aims to answer are:
* difference in percentage growth of total atherosclerotic plaque volume (+ calcified and non-calcified plaque volume) in the descending thoracic segment of the aorta * difference in percentage growth of total atherosclerotic plaque volume (+ calcified and non-calcified plaque volume) in coronary arteries.
Researchers will compare patients that receive ICI-therapy and atorvastatin with patients that receive ICI-therapy + placebo to see if atorvastatin will prevent accelerated ICI induced plaque growth.
Inclusion: In order to be eligible to participate in this study, a subject must meet all of the following criteria:; Age ≥ 18 years; Able to understand the written information and able to give informed consent; Melanoma diagnosis with planned ICI treatment according to standard of care (nivolumab, pembrolizumab, monotherapy or combination therapy with ipilimumab); Presence of atherosclerosis in the descending thoracic aorta at baseline.
Exclusion: Baseline statin use or previously reported statin intolerance; Current or recent (≤1 year) history of alcohol or drug abuse; Use of essential medication with (potential) interactions with atorvastatin, including:; strong CYP3A4 inhibitors such as clarithromycin, ciclosporin, itraconazol, ketoconazole, voriconazol, posconazol, HCV agents, HIV protease inhibitors; BCRP inhibitors such as elbasvir and grazoprevir; Fibrates (including gemfibrozil); Contra-indication for statin therapy, including:; Active liver disease, including ALT/AST levels ≥ 3x ULN; (History of) myopathy Congenital muscular disorder History of (drug-induced) rhabdomyolysis History of drug-induced myopathy with elevated creatine kinase (CK); Severe kidney failure (creatinine clearance < 30 ml/min); Pregnancy or lactation; Life expectancy < 12 months; High MESA-score at baseline.