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Atorvastatin 40mg, daily, orally for 18 months

No comparator treatment/placebo allocated

Atorvastatin Calcium 40Mg Tab

Julie Butters

Mary-Anne Austin

Prof Stephen Nicholls

Vivienne Nguyen

Prof Gary Richardson

Silvia Pongracic

Dr Bhavini Shah

Stephen J Nicholls, MBBS, PhD

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.

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

The Steering Committee will decide if and how IPD will be shared. It is expected that study Co Investigators will be able to access data once the primary results have been presented.

Difference in non-calcified plaque volume as measured on serial CTCA between patients treated with and without statin therapy

Difference in total plaque volume as measured on serial CTCA between patients treated with ICI therapy against historical cohorts

Difference in pericoronary adipose tissue attenuation and volume as measured on serial CTCA between patients treated with and without statin 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

Incidence and number of patients treated with and without statin therapy with reported adverse events and serious adverse events

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

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS	NCT05180942	Melanoma Atherosclerosis	Atorvastatin Ca...	40 Years -	Monash University
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS	NCT05180942	Melanoma Atherosclerosis	Atorvastatin Ca...	40 Years -	Monash University

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