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

Phase 2

Recruiting

• Conditions: Melanoma; Atherosclerosis
• Interventions: Drug: Atorvastatin Calcium 40Mg Tab

• Registration Number: NCT05180942
• Lead Sponsor: Monash University

Brief Summary

This study is a prospective observational study evaluating the natural history of coronary plaque burden in participants with melanoma treated with ICI. The study will be conducted at various sites across Australia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-12-19
• Study First Posted: 2022-01-06
• Study Start: 2022-11-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Capable of providing informed consent and willing to adhere to all protocol requirements
• patients aged > or equal to 40 years
• Histologically confirmed melanoma of any stage planned for, commenced, or completed treatment with ICI
• having acceptable imaging quality deemed by the core laboratory
• Investigator believes that the participant is willing to adhere to all protocol requirements, including returning for follow up CTCA.

Exclusion Criteria

• Known clinically manifest cardiovascular disease
• Female participants must not be pregnant, breastfeeding or plan to become pregnant during the study.
• Estimated glomerular filtration rate of <45 mL/min calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
• Severe liver disease or cirrhosis
• History of any other malignancy within the past 5 years in addition to melanoma with the exception of non-melanoma skin cancers
• Prognostic factors associated with an expected survival less than 18 months at Investigators' discretion (e.g. unresectable brain metastases)
• Evidence of any other clinically significant non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participation in the study
• Major allergy to iodine
• Participation in another clinical trial that does not allow participation in multiple trials at the same time

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Statin treatment	Atorvastatin Calcium 40Mg Tab	Atorvastatin 40mg, daily, orally for 18 months

Primary Outcome Measures

Name	Time	Method
To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs.	18 months	The change in non-calcified coronary plaque volume will be measured on serial computed tomography coronary angiography scans.

Secondary Outcome Measures

Name	Time	Method
To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs.	18 months
To determine the relationship between statin use and the burden, composition and progression of coronary atherosclerosis in individuals with melanoma treated with ICIs.	18 months	The change in non-calcified coronary plaque volume as measured on serial computed tomography coronary angiography scans will be compared between patients treated with statins and patients not treated with statins in the study.
To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs.	18 months	The number of patients who were started on statin therapy by their treating clinicians after undergoing computed tomography coronary angiography in the study will be recorded.
To evaluate the impact of participation in a cardio-oncology trial on measures of quality of life in patients with melanoma treated with ICIs.	18 months	Quality of life will be assessed by using the PHQ-9, GAD-7, EORTC QLQ-C30, EuroQOL EQ-5D, and FACT-M questionnaires at baseline and at 18 month follow up. The change in quality of life scores on each questionnaire will be compared with historical cohorts that have previously been reported in the literature.
To determine the incidence of major atherosclerotic cardiovascular events in patients with melanoma treated with ICIs.	18 months
To determine progression free survival with regard to the underlying melanoma following treatment with ICIs.	18 months
To determine overall survival in patients with melanoma treated with ICIs.	18 months

Trial Locations

Locations (8)

Calvary Mater Newcastle; 🇦🇺 Waratah, New South Wales, Australia

Ipswich Hospital; 🇦🇺 Ipswich, Queensland, Australia

Queen Elizabeth Hospital; 🇦🇺 Woodville South, South Australia, Australia

Monash Health; 🇦🇺 Clayton, Victoria, Australia

Peninsula Health; 🇦🇺 Frankston, Victoria, Australia

Cabrini Health; 🇦🇺 Malvern, Victoria, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Mildura Public Base Hospital; 🇦🇺 Mildura, Victoria, Australia