SOCRATES

Preventative treatment for melanoma patients at risk of heart disease

For patients with melanoma, drugs called immune checkpoint inhibitors (ICIs) have been proven an effective treatment option. Since their introduction into clinical practice, long term side-effects on the heart have increasingly been reported in some patients treated with ICIs. These side-effects include increased inflammation and cholesterol deposits in the heart blood vessels.

The SOCRATES clinical trial (Statins and prOgression of Coronary atheRosclerosis in melanomA patients Treated with chEckpoint inhibitorS), led by the Director of the Monash Victorian Heart Institute, Prof Stephen Nicholls, is looking to understand the build-up of cholesterol deposits, also referred to as atherosclerosis or plaque in the vessels of the heart, in melanoma patients treated with immunotherapy. As part of this clinical trial, images of the heart will be taken over time using Computed Tomography Coronary Angiography (CTCA).

The trial is being conducted at various hospital sites and clinics throughout Australia and aims to enrol 130 people nationally.

This research is funded by the Federal Government’s Medical Research Future Fund and is sponsored and coordinated by Monash University, with assistance from Melanoma and Skin Cancer Trials (MASC Trials).

MASC Trials has an academic affiliation with Monash University, with a dedicated centre supporting its research activities, the Melanoma and Skin Cancer Research Centre, within the School of Public Health and Preventative Medicine.

Eligibility

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. There are additional criteria that the study doctor will assess to determine if the trial is suitable for the patient.

Further details about inclusion and exclusion criteria can be found here.

What's involved?

Once deemed eligible, participants will followed up for a period of 18 months. During this time, patients will be contacted for monitoring; including six monthly follow up phone calls from a research nurse, and a clinic or tele-health visit at 18 months for blood collection and repeat CTCA imaging.

Why should I join SOCRATES?

While treatment and prognosis of cancer continues to improve with a range of ICIs available, more research is needed to address the related increased risk of cardiovascular disease and its impact on long-term outcomes and survivorship.

Participants in the SOCRATES clinical trial will help the researchers to determine if preventative treatment with statins have a positive effect on long-term outcomes and survival rates for many melanoma patients.

The SOCRATES clinical trial represents a unique and much needed collaborative effort between oncology, dermatology and cardiology to address an emerging topic in melanoma and cancer care.

Trial resources

For healthcare providers and patients

SOCRATES Trial Team

Prof Stephen Nicholls (Study chair, Cardiologist, Director of Monash Heart and Victorian Heart Institute)
Prof Eva Segelov (Medical Oncologist, Director of Oncology, Monash Health)
Prof Mark Shackleton (Medical Oncologist, Director of Oncology, Alfred Health)
Prof Grant McArthur (Medical Oncologist, Head of Molecular Oncology, Peter MacCallum Cancer Centre)
A/Prof Andrew Haydon (Medical Oncologist, Alfred Health)
Prof Sophia Zoungas (Head of School of Public Health and Preventative Medicine, Monash University)
Prof Victoria Mar (Dermatologist, Director of the Victorian Melanoma Service)

A/Prof Nitesh Nerlekar (Cardiologist, Monash Health)
Prof Danny Liew (Clinical Epidemiologist, Dean, Faculty of Medicine, University of Adelaide)
Dr Elizabeth Ahern (Medical Oncologist, Monash Health)
Mr Domenic Sacca (Project management, Victorian Heart Institute)
Dr Sean Tan (Cardiologist, Project management, Victorian Heart Institute)
Mr Giuseppe Di Giovanni (Imaging Project Manager, SAHMRI)
Ms Katja Loewe (Site set-up and activation, MASC Trials)
Ms Louise Gonzales (Site set-up and activation, MASC Trials)
Ms Madeleine Muller (Site set-up and activation, MASC Trials)