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

Launched by MONASH UNIVERSITY · Dec 19, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how a common medication called statins might affect heart health in patients with melanoma who are receiving a type of cancer treatment known as checkpoint inhibitors. Specifically, the study will check if statins can help reduce the buildup of plaque in the arteries, which is important because plaque can lead to heart problems. The trial is open to adults aged 40 and older who have been diagnosed with stage 2, 3, or 4 melanoma and have not been treated with statins before.

Participants in the trial will be monitored over time to see how their heart health changes while taking statins. To be eligible, individuals must be able to provide consent and agree to regular check-ups, but they cannot have serious heart conditions, liver, or kidney diseases that might interfere with the study. This trial is currently recruiting participants, and it offers a chance to help researchers learn more about the potential benefits of statins in improving heart health for melanoma patients.

Gender

ALL

Eligibility criteria

• 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