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

August 20, 2025 updated by: Stephen Nicholls, Monash University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
      • Waratah, New South Wales, Australia, 2298
    • Queensland
      • Bundaberg, Queensland, Australia, 4670
      • Hervey Bay, Queensland, Australia, 4655
      • Ipswich, Queensland, Australia, 4305
        • Recruiting
        • Ipswich Hospital
        • Contact:
          • Lisa Smith
        • Principal Investigator:
          • Dr Nazeer Upanal
      • Toowoomba, Queensland, Australia, 4350
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Recruiting
        • Queen Elizabeth Hospital
        • Contact:
        • Principal Investigator:
          • Dr Rachel Roberts-Thomson
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Frankston, Victoria, Australia, 3199
      • Malvern, Victoria, Australia, 3144
      • Melbourne, Victoria, Australia, 3051
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
        • Principal Investigator:
          • Dr Aparna Rao
      • Mildura, Victoria, Australia, 3500
        • Recruiting
        • Mildura Public Base Hospital
        • Contact:
        • Principal Investigator:
          • Dr Krishna Rachakonda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 40 years and older with melanoma of any stage, who are planned for, currently receiving or have received treatment with an ICI may be considered for this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental: Statin treatment
Atorvastatin 40mg, daily, orally for 18 months
Drug: Atorvastatin Calcium 40Mg Tab
One tablet daily
No Intervention: No statin treatment
No comparator treatment/placebo allocated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs.
Time Frame: 18 months
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.
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.
18 months
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.
18 months
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.
18 months
To determine the incidence of major atherosclerotic cardiovascular events in patients with melanoma treated with ICIs.
Time Frame: 18 months
18 months
To determine progression free survival with regard to the underlying melanoma following treatment with ICIs.
Time Frame: 18 months
18 months
To determine overall survival in patients with melanoma treated with ICIs.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University

Collaborators

National Health and Medical Research Council, Australia

Investigators

  • Principal Investigator: Stephen J Nicholls, MBBS, PhD, Monash University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 11, 2021

First Submitted That Met QC Criteria

December 19, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOCRATES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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