Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy or lactation
Baseline statin use or previously reported statin intolerance
Current or recent (≤1 year) history of alcohol or drug abuse
Active liver disease, including ALT/AST levels ≥ 3x ULN
Trial design
Design model
Parallel
Treatments tested in this trial
Atorvastatin
DrugDaily 20mg atorvastatin.
Placebo
DrugDaily Placebo in combination with ICI-therapy
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Intervention/ Atorvastatin armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentual annual growth of atherosclerotic plaques in the descending thoracic aorta
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.
Time frame
1 yearSecondary outcomes
1
Difference in percentage increase in non-calcified and calcified atherosclerotic plaque volume in the descending thoracic aorta
Difference in percentage increase in non-calcified and calcified atherosclerotic plaque volume in the descending thoracic aorta 1 year after the start of ICI therapy in the intervention versus the control group
Time frame
1 year2
Difference in percentage increase in total, non-calcified and calcified coronary artery atherosclerotic plaque volume
Difference in percentage increase in total, non-calcified and calcified coronary artery atherosclerotic plaque volume
Time frame
1 year3
Difference in increase in coronary calcification score (Agatston score) and Multi-Ethnic Study of Atherosclerosis (MESA) score
Difference in increase in coronary calcification score (Agatston score) and MESA score. MESA score calculates the 10-year risk in percentage of developing coronary heart disease.
Time frame
1 year4
Difference in change in epicardial fat volume
Difference in change in epicardial fat volume
Time frame
1 yearOther outcomes
1
The effect of atorvastatin on median Progression Free Survival in months
The median progression free survival (PFS) in patients with advanced melanoma will be obtained after one and three years and will be calculated in months. Progression Free Survival (PFS) is defined as duration from randomization until disease progression.
Time frame
1 and 3 years2
The effect of statins on the median Overall Survival in months
The effect of statins on the median overall survival in months in patients with advanced disease after 1 and after 3 years. Overall Survival (OS) is defined as the duration from randomization until death from any cause
Time frame
1 and 3 years3
The effect of statins on the median Event Free Survival in months
The effect of statins on the median Event Free Survival in months in patients with advanced disease after 1 and after 3 years. Event Free Survival (EFS) is defined as the time from the start of the study treatment to the occurrence of progression to unresectable melanoma before surgery (in the neoadjuvant setting), disease recurrence, or death due to melanoma or due to treatment, whichever occurs first.
Time frame
1 and 3 years4
Difference in various concentration levels of hemostatic biomarkers
Difference in change in concentration levels of various markers of the hemostatic system activation (including d-dimer, fibrinogen, factor VIII, von Willebrand factor) between the intervention and control group at 3 months, 6 months, and 1 year after the start of ICIs.
Time frame
Baseline, 3 months, 6 months and 1 year after the start of ICI therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Amphia Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: