Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05180942

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nepean Hospital, Kingswood, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs.

    Time frame: 18 months

    The change in non-calcified coronary plaque volume will be measured on serial computed tomography coronary angiography scans.

Secondary outcomes

  1. To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs.

    Time frame: 18 months

  2. To determine the relationship between statin use and the burden, composition and progression of coronary atherosclerosis in individuals with melanoma treated with ICIs.

    Time frame: 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.

  3. To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs.

    Time frame: 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.

  4. To evaluate the impact of participation in a cardio-oncology trial on measures of quality of life in patients with melanoma treated with ICIs.

    Time frame: 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.

  5. To determine the incidence of major atherosclerotic cardiovascular events in patients with melanoma treated with ICIs.

    Time frame: 18 months

  6. To determine progression free survival with regard to the underlying melanoma following treatment with ICIs.

    Time frame: 18 months

  7. To determine overall survival in patients with melanoma treated with ICIs.

    Time frame: 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Domenic Sacca

CONTACT

[email protected]

+61 (0) 423245187

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Acronym: SOCRATES

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2022
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.