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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Monash University
• Collaborator: National Health and Medical Research Council, Australia
• Treatments: Atorvastatin; Calcium

Criteria

Inclusion Criteria:

• patients aged > or equal to 40 years

• 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 (eg. un-resectable brain metastases)

• 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