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.

As ICI drugs are life-saving and are widely used in cancer treatment, there is an urgent need to discover a solution that counteracts the negative effects on the heart for patients treated with ICIs.

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, aims to determine the effect of statins (a class of drugs that lower cholesterol in the blood) on the progress of atherosclerosis (build-up of cholesterol in arteries, causing obstruction of blood flow) of the heart in patients with melanoma treated with an ICI. As part of this clinical trial, images of the heart will be taken over time using Computed Tomography Coronary Angiography (CTCA).

The trial aims to recruit 180 patients across 12 sites around Australia and will run for 18 months.

Trial participants will be randomly allocated to either taking a pill containing 40mg Atorvastatin (a commonly prescribed statin) daily or no treatment for the duration of the trial.

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 do not meet current PBS criteria for statin therapy and are planned for treatment/have been treated with an ICI for less than three months are eligible to take part. 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 proceed to the randomisation phase. They will either receive a daily treatment with 40mg Atorvastatin or no treatment within four weeks of having baseline CTCA imaging.

All participants will receive lifestyle advice in accordance with cardiovascular disease prevention guidelines and short questionnaires to determine their current standards of lifestyle and daily living.

The study treatment duration is 18 months. During this period, patients will have trial assessments to monitor their safety and treatment progress; including six monthly follow up phone calls from a research nurse, a clinic visit at month 1 for blood collection and repeat CTCA imaging at 18 months.

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 Atorvastatin can avoid the development of cardiovascular disease in melanoma patients treated with ICIs.

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

  • TBC

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)
  • A/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)
  • Ms Julie Butters (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)

Trial sites currently recruiting patients

Victoria

  • Monash Health, Melbourne
  • Cabrini Health, Melbourne
  • Latrobe Regional Hospital, Traralgon

Contact and more information

SOCRATES News

To contact the SOCRATES clinical trial email socrates.study@monash.edu

SOCRATES clinical trial Registration ID: NCT05180942

For information on how to participate in a clinical trial, click here

5 June 2023
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