What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran). The registry lists allocation as randomized. Immune checkpoint inhibitors (ICIs) are a class of medications that are now standard in the treatment of melanoma.
They plan to enroll about 40 people at Aurora. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Lipid Lowering Therapy for Atherosclerotic Disease in Melanoma Patients Receiving Immune Checkpoint Inhibitors
Interventions: Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)
Primary outcome (registry wording): Mean change in LDL-C from baseline to 12 months