Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma

This study is looking for both males and females aged 12 and older who have advanced melanoma that cannot be removed by surgery or has spread. Your doctors will need to confirm the type of melanoma you have and check some specific features of your cancer cells, including something called 'BRAF V600 mutation status' and 'PD-L1 expression level'.

To join the main part of the study, you shouldn't have previously received certain types of immunotherapy medicines. You also need to be generally well enough to take part, as measured by a health score that your doctor will explain. Your cancer must also have at least one area that can be measured accurately by scans.

There's a special group for adults whose melanoma has spread to the brain and is growing, and for teenagers (aged 12-17) with melanoma. Even if you have brain metastases, you might be able to join this specific group if you meet other health requirements.

If you decide to join this study, you would first undergo a series of checks to make sure you are suitable. If you qualify for the main part of the study, you will be randomly assigned to one of two groups, like flipping a coin. You won't know which group you are in, and neither will your doctors (this is called 'double-blind'). One group will receive HBI-8000 pills and nivolumab injections, and the other will get dummy pills (placebo) and nivolumab injections.

You'll take the HBI-8000 or placebo pills twice a week, about 30 minutes after a meal. Nivolumab will be given as a drip into your vein once every 28 days. These treatments usually continue for up to two years, or until your cancer gets worse, you experience side effects that are too much to handle, or you decide to stop.

For the separate group of patients (adults with brain spread or teenagers), there's no random assignment or placebo; everyone receives HBI-8000 and nivolumab on the same schedule.