POLARIS Melanoma TrialMelanoma with Brain Metastasis
Clinical Research Study for Adults with Melanoma that has spread to the Brain
POLARIS is a Phase 2 research trial testing a potential new treatment for BRAFV600-mutant positive melanoma that has spread to the brain. The new treatment is called encorafenib (Braftovi) + binimetinib (Mektovi).
About the Study
The purpose of this research trial is to determine if high‑dose encorafenib and binimetinib versus standard-dose encorafenib and binimetinib are safe and effective in melanoma that has spread to the brain. The standard dose of encorafenib + binimetinib has been approved by the Therapeutic Goods Association (TGA) in Australia for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation but not for the treatment of melanoma that has spread to the brain.
The first 9 participants included in the study will receive the high-dose treatment. If the results from these 9 participants show that the high dose is tolerated, additional participants will be enrolled and randomly assigned to either the standard-dose or the high‑dose encorafenib and binimetinib combination treatment.
If the high dose is not tolerated, all participants will receive the standard dose of encorafenib and binimetinib combination treatment.
Study Conduct and Design
The POLARIS study will enroll approximately 100 patients with melanoma brain metastasis. If you enroll, you will be involved in the study for up to 2 years.
There will be 3 types of visits during this study: screening visit, study treatment period visits and post-treatment period visits. During the screening period, the study staff will check your health and make sure that you are suitable to participate in the study. This can take up to 28 days to complete and may include more than one visit.
If you meet the requirements to enter the study and agree to participate, you will return to the research centre to begin the study. The treatment visits will occur on cycles of 28 days. You will be requested to visit the research centre on days 1 and 15 of Cycle 1, day 1 of Cycle 2, and days 1 and 15 of all the following Cycles.
You’ll have 2 post-treatment visits at the study doctor’s office, first when you stop receiving the study drugs, and then 30 days after your first post-treatment visit.
Later, you’ll talk to the study doctor or staff about every 12 weeks, either in the study doctor’s office or over the telephone.
You may be eligible if you:
- Are 18 years of age or older
- Have a confirmed diagnosis of melanoma that has spread to the brain
- Have received no more than 1 prior line of checkpoint inhibitor therapy (eg Keytruda, Opdivo, Yervoy)
- Are able to carry out work of a light or sedentary nature (eg office work, light house work)
- Have not had any localised treatment for the melanoma in the brain
We will assess further inclusion and exclusion criteria at the screening visit to determine eligibility.
To learn more about this clinical research study, please talk to your oncologist. You may also:
- Visit the clinical trial registry entry.
- Contact our nursing staff on (08) 9242 7640 or email email@example.com