Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the Netherlands / NCT06785974
Starting soon Phase 4

Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis

NCT06785974 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Erasmus Medical Center
Phase
Phase 4
Started
2025-02
Last updated
2025-01-22

Condition(s) studied

AtherosclerosisMelanomaImmune-related Adverse Event

Investigational drug(s) / intervention(s)

Atorvastatin →Placebo

Atorvastatin: Daily 20mg atorvastatin.

Placebo: Daily Placebo in combination with ICI-therapy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Pregnancy or lactation * Baseline statin use or previously reported statin intolerance * Current or recent (≤1 year) history of alcohol or drug abuse * 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) * 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) * Life expectancy \< 12 months * High MESA-score at baseline

Primary outcome measure(s)

  • Percentual annual growth of atherosclerotic plaques in the descending thoracic aorta — 1 year
    The percentage difference in atherosclerotic plaque volume in the descending part of the thoracic after 1 year of ICI-therapy will be compared to the atherosclerotic plaque volume at baseline.

Trial sites (1)

FacilityCityRegionStatus
Erasmus Universitair Medisch Cetrum Rotterdam Rotterdam South Holland

On this site

📄 Lipitor (atorvastatin) drug profile →

More Erasmus Medical Center trials in the Netherlands

The Regenerative Capacity of the Donor Liver After Living Donor Liver Transplantation: an Ambidirectional Cohort Study Enrolling by invitation
Treatment of Exertional Heatstroke witH icE wAter Soaked Towels Active, not recruiting
DEntal implaNt Set: Development and Implementation of a Standardized Outcome Set in Implant Dentistry Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial Recruiting
Sweet & Sour: Dietary Acid Load in Type 2 Diabetes and Kidney Disease Across Sex and Ethnic Groups Starting soon

Other trials for the same condition

A Study of BI 3810944 in Patients With Advanced Cancer Recruiting
Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion Recruiting
Measuring Athlete's Risk of Cardiovascular Events 3 (MARC-3) Enrolling by invitation
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma Active, not recruiting
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06785974 on ClinicalTrials.gov ↗ ← All trials in the Netherlands