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

Last updated: April 8, 2025
Sponsor: Monash University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Coronary Artery Disease

Melanoma

Treatment

Atorvastatin Calcium 40Mg Tab

Clinical Study ID

NCT05180942
SOCRATES
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Capable of providing informed consent and willing to adhere to all protocolrequirements

  • patients aged > or equal to 40 years

  • Histologically confirmed melanoma of any stage planned for, commenced, or completedtreatment with ICI

  • having acceptable imaging quality deemed by the core laboratory

  • Investigator believes that the participant is willing to adhere to all protocolrequirements, including returning for follow up CTCA.

Exclusion

Exclusion Criteria:

  • Known clinically manifest cardiovascular disease

  • Female participants must not be pregnant, breastfeeding or plan to become pregnantduring the study.

  • Estimated glomerular filtration rate of <45 mL/min calculated using the ChronicKidney Disease Epidemiology Collaboration equation

  • Severe liver disease or cirrhosis

  • History of any other malignancy within the past 5 years in addition to melanoma withthe exception of non-melanoma skin cancers

  • Prognostic factors associated with an expected survival less than 18 months atInvestigators' 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 inmultiple trials at the same time

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: Atorvastatin Calcium 40Mg Tab
Phase:
Study Start date:
November 07, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Ipswich Hospital

    Ipswich, Queensland 4305
    Australia

    Active - Recruiting

  • Queen Elizabeth Hospital

    Woodville South, South Australia 5011
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Peninsula Health

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • Cabrini Health

    Malvern, Victoria 3144
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3051
    Australia

    Active - Recruiting

  • Mildura Public Base Hospital

    Mildura, Victoria 3500
    Australia

    Active - Recruiting

  • Latrobe Regional Hospital

    Traralgon, Victoria 3844
    Australia

    Site Not Available

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