MelanomaSOCRATESNCT05180942
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
An observational study of Melanoma and Atherosclerosis, run by Monash University at 12 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Melanoma, Atherosclerosis
- How many people
- 130 participants
- Where
- 12 sitesAustralia
- Study dates
- 7 Nov 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
12 sites in 1 country.
12 sites in 1 country
Australia12 sites
Bundaberg Base Hospital
Bundaberg, Queensland, 4670
Monash Health
Clayton, Victoria, 3168
Peninsula Health
Frankston, Victoria, 3199
Hervey Bay Hospital
Hervey Bay, Queensland, 4655
Ipswich Hospital
Ipswich, Queensland, 4305
Nepean Hospital
Kingswood, New South Wales, 2747
Cabrini Health
Malvern, Victoria, 3144
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3051
Mildura Public Base Hospital
Mildura, Victoria, 3500
Toowoomba Hospital
Toowoomba, Queensland, 4350
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Queen Elizabeth Hospital
Woodville South, South Australia, 5011
About this study
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.
- Conditions
- Melanoma, Atherosclerosis
- Medical subject headings
- Melanoma, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs.
The change in non-calcified coronary plaque volume will be measured on serial computed tomography coronary angiography scans.
Measured: 18 months
Secondary outcomes (7)
To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs.
Measured: 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.
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.
Measured: 18 months
To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs.
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.
Measured: 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.
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.
Measured: 18 months
To determine the incidence of major atherosclerotic cardiovascular events in patients with melanoma treated with ICIs.
Measured: 18 months
To determine progression free survival with regard to the underlying melanoma following treatment with ICIs.
Measured: 18 months
To determine overall survival in patients with melanoma treated with ICIs.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start7 Nov 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Stephen Nicholls, Monash University
- Investigators
- Stephen J Nicholls, MBBS, PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180942
- Sponsor's protocol ID
- SOCRATES
- Acronym
- SOCRATES
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
- ClinicalTrials.gov ID
- NCT05180942
- Acronym / sponsor ID
- SOCRATES / SOCRATES
- Conditions
- Melanoma, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
To determine the prevalence of CV risk factors in individuals with melanoma treated with ICIs.
Time frame: 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
To examine the impact of using CTCA to guide preventative therapy with statins in patients with melanoma treated with ICIs.
Time frame: 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
To determine the incidence of major atherosclerotic cardiovascular events in patients with melanoma treated with ICIs.
Time frame: 18 months
To determine progression free survival with regard to the underlying melanoma following treatment with ICIs.
Time frame: 18 months
To determine overall survival in patients with melanoma treated with ICIs.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Nicholls, MBBS, PhD principal investigator
Monash University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Atherosclerosis, run by Monash University at 12 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the natural history of the burden and composition of coronary atherosclerosis in individuals with melanoma treated with ICIs. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.