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

Study Purpose

This study will incorporate a prospective randomised open blinded end-point trial in participants with stage 2, 3 or 4 melanoma treated with ICI to evaluate the impact of statin therapy on changes in coronary plaque burden and composition.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - patients aged > or equal to 40 years.
  • - historical or current diagnosis of stage 2, 3 or 4 melanoma treated with an ICI.
  • - not currently treated with a statin ,and.
  • - having acceptable imaging quality deemed by the core laboratory.

Exclusion Criteria:

  • - inability to provide informed consent.
  • - unwilling to be followed for serial evaluation.
  • - contra-indication or intolerance to statins.
  • - clinically manifest CV disease.
  • - prognostic factors associated with an expected survival less than 18 months.
- severe liver disease or advanced renal disease (³stage 3b CKD or eGFR <45 ml/min) - any other factor that will preclude patients from participating in all study related activities

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05180942
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Monash University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stephen J Nicholls, MBBS, PhD
Principal Investigator Affiliation Monash University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma, Atherosclerosis
Arms & Interventions

Arms

Experimental: Statin treatment

Atorvastatin 40mg, daily, orally for 18 months

No Intervention: No statin treatment

No comparator treatment/placebo allocated

Interventions

Drug: - Atorvastatin Calcium 40Mg Tab

One tablet daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Monash Health, Clayton, Victoria, Australia

Status

Recruiting

Address

Monash Health

Clayton, Victoria, 3168

Site Contact

Mary-Anne Austin

Maryanne.Austin@monashhealth.org

+61434679018

Cabrini Health, Malvern, Victoria, Australia

Status

Recruiting

Address

Cabrini Health

Malvern, Victoria, 3144

Site Contact

Vivienne Nguyen

ThuNguyen@cabrini.com.au

+61434679018

Latrobe Regional Hospital, Traralgon, Victoria, Australia

Status

Recruiting

Address

Latrobe Regional Hospital

Traralgon, Victoria, 3844

Site Contact

Silvia Pongracic

SPongracic@lrh.com.au

+61434679018

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