Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS

Melanoma Clinical Trial

— SOCRATES  

Official title:

Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180942
• Other study ID #: SOCRATES
• Status: Recruiting
• Phase: Phase 2
• Start date: November 7, 2022
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Monash University
• Contact: Julie Butters
• Phone: +61434679018
• Email: julie.butters[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will incorporate a prospective randomised open blinded end-point trial in participants with stage 2, 3 or 4 melanoma treated with ICI to evaluate the impact of statin therapy on changes in coronary plaque burden and composition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• patients aged > or equal to 40 years
• historical or current diagnosis of stage 2, 3 or 4 melanoma treated with an ICI
• not currently treated with a statin ,and
• having acceptable imaging quality deemed by the core laboratory

Exclusion Criteria:

• inability to provide informed consent
• unwilling to be followed for serial evaluation
• contra-indication or intolerance to statins
• clinically manifest CV disease
• prognostic factors associated with an expected survival less than 18 months
• severe liver disease or advanced renal disease (³stage 3b CKD or eGFR <45 ml/min)
• any other factor that will preclude patients from participating in all study related activities

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Melanoma
• Myocardial Ischemia

Intervention

Drug:
• Atorvastatin Calcium 40Mg Tab
One tablet daily

Locations

Country	Name	City	State
Australia	Monash Health	Clayton	Victoria
Australia	Cabrini Health	Malvern	Victoria
Australia	Latrobe Regional Hospital	Traralgon	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in non-calcified plaque volume according to treatment with statins	Difference in non-calcified plaque volume as measured on serial CTCA between patients treated with and without statin therapy	18 months
Secondary	Change in total plaque volume in patients treated with ICI compared to historical cohorts	Difference in total plaque volume as measured on serial CTCA between patients treated with ICI therapy against historical cohorts	18 months
Secondary	Change in pericoronary adipose tissue attenuation and volume according to treatment with statins	Difference in pericoronary adipose tissue attenuation and volume as measured on serial CTCA between patients treated with and without statin therapy	18 months
Secondary	Cost-effectiveness of the use of CTCA as measured by net costs per life year gained in patients with melanoma treated with ICI therapy	Differences in cost-effectiveness ratios in terms of net costs per life year gained between patients with melanoma treated with ICI therapy who had CTCA performed compared to historical cohorts who did not have CTCA performed	18 months
Secondary	Incidence of adverse events with statin therapy	Incidence and number of patients treated with and without statin therapy with reported adverse events and serious adverse events	18 months
Secondary	Cost-effectiveness of statin therapy in patients with melanoma treated with ICI therapy as measured by net costs per life year gained	Difference in cost-effectiveness ratios between patients with melanoma on ICI therapy who are treated with and without statin therapy, in terms of net costs per life year gained	18 months
Secondary	Effect of statins on depression in patients with melanoma treated with ICI therapy as measured on the Patient Health Questionnaire-9	Differences in mean changes in scores for the Patient Health Questionnaire-9 for each patient according to statin use, with a minimum score of 0 and a maximum score of 27, and higher scores indicating higher likelihood of depression	18 months
Secondary	Effect of statins on anxiety in patients with melanoma treated with ICI therapy as measured on the Generalized Anxiety Disorder-7 questionnaire	Differences in mean changes in scores for the Generalized Anxiety Disorder-7 questionnaire for each patient according to statin use, with a minimum score of 0 and a maximum score of 21, and higher scores indicating higher likelihood of anxiety	18 months
Secondary	Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire	Differences in mean changes in scores for the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire for each patient according to statin use, with a minimum score of 30 and a maximum score of 126, and higher scores indicating poorer quality of life	18 months
Secondary	Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the EuroQoL Group EQ-5D questionnaire	Differences in mean changes in scores for the EuroQoL Group EQ-5D questionnaire for each patient according to statin use, with a minimum score of 1 and a maximum score of 15, and higher scores indicating poorer quality of life	18 months
Secondary	Effect of statins on quality of life in patients with melanoma treated with ICI therapy as measured on the FACT-M questionnaire	Differences in mean changes in scores for each section of the FACT-M questionnaire for each patient according to statin use.; The score ranges for each individual section are: physical well-being 0-28, social well-being 0-28, emotional well-being 0-24, functional well-being 0-28, additional well-being 0-64, and melanoma-specific questions 0-32.; Interpretation of scoring depends on the individual sections in the questionnaire, with higher scores in the physical, emotional, additional and melanoma-specific questions indicating poorer quality of life, whilst lower scores in the social and emotional questions indicate poorer quality of life	18 months