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

Monash University

Status and phase: Enrolling; Phase 2

Conditions: Melanoma; Atherosclerosis

Treatments: Drug: Atorvastatin Calcium 40Mg Tab

Study type: Observational

Funder types: Other

Identifiers

NCT05180942

SOCRATES

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

130 participants in 2 patient groups

Statin treatment

Experimental group

Description:

Atorvastatin 40mg, daily, orally for 18 months

Treatment:

Drug: Atorvastatin Calcium 40Mg Tab

No statin treatment

No Intervention group

Description:

No comparator treatment/placebo allocated