Evaluating heart health in melanoma patients treated with immune checkpoint inhibitors
Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS
This study looks at how immune checkpoint inhibitors for melanoma affect heart health in patients aged 40 and older by monitoring their heart condition over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Monash University Academic / other |
| Locations | 12 sites (Kingswood, New South Wales and 11 other locations) |
| Trial ID | NCT05180942 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the progression of coronary plaque burden in patients with melanoma who are undergoing treatment with immune checkpoint inhibitors (ICIs). Participants will be monitored for their cardiovascular health through imaging techniques to understand the relationship between melanoma treatment and heart health. The study will take place across various sites in Australia, focusing on patients aged 40 and older with confirmed melanoma. The findings could provide insights into the cardiovascular risks associated with ICI therapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates are melanoma patients aged 40 and older who are currently receiving or have completed treatment with immune checkpoint inhibitors.
Not a fit: Patients with known cardiovascular disease or severe liver disease, as well as those with a recent history of other malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify cardiovascular risks in melanoma patients undergoing ICI treatment, leading to better management strategies.
How similar studies have performed: While there is ongoing research into the cardiovascular effects of cancer treatments, this specific focus on melanoma patients treated with ICIs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kingswood, New South Wales and 11 other locations
- Nepean Hospital — Kingswood, New South Wales, Australia (Recruiting)
- Calvary Mater Newcastle — Waratah, New South Wales, Australia (Recruiting)
- Bundaberg Base Hospital — Bundaberg, Queensland, Australia (Recruiting)
- Hervey Bay Hospital — Hervey Bay, Queensland, Australia (Recruiting)
- Ipswich Hospital — Ipswich, Queensland, Australia (Recruiting)
- Toowoomba Hospital — Toowoomba, Queensland, Australia (Recruiting)
- Queen Elizabeth Hospital — Woodville South, South Australia, Australia (Recruiting)
- Monash Health — Clayton, Victoria, Australia (Recruiting)
- Peninsula Health — Frankston, Victoria, Australia (Recruiting)
- Cabrini Health — Malvern, Victoria, Australia (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
- Mildura Public Base Hospital — Mildura, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Stephen J Nicholls, MBBS, PhD — Monash University
- Study coordinator: Domenic Sacca
- Email: domenic.sacca@monash.edu
- Phone: +61 (0) 423245187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.