A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients

To join this study, you must have melanoma that has spread or cannot be removed by surgery, and it must not have responded to a previous treatment involving anti-PD1 drugs. This means your cancer would have gotten worse after at least six weeks of that type of treatment. Doctors will need to see clear signs of the cancer on scans.

You need to be at least 18 years old and generally well enough to take part, meaning you can do most of your daily activities without much trouble. Your important organs like your liver and kidneys also need to be working properly. If you are a woman who could become pregnant, you must not be pregnant or breastfeeding and must agree to use effective birth control. Men must also use effective birth control if their partner could become pregnant.

There are also reasons why you might not be able to join. For example, if you've had other treatments for your melanoma after your anti-PD1 therapy failed, or if you've recently had major surgery or radiation to the parts of your body where we'd be looking at the cancer. The study team will review all your medical information carefully to see if it's right for you.

If you decide to take part, you'll first have a number of tests and checks to make sure the study is right for you. This will include blood tests and scans. You'll then receive the study drugs, MB097 and Pembrolizumab, and Vancomycin, over a period of time. You'll have regular visits to the clinic for medical check-ups, more blood tests, and scans to see how you're responding and to monitor any side effects.

The research team will explain the full schedule of visits and treatments in detail during the informed consent process. You will be closely monitored throughout the study. The total time you would be involved in the study would depend on your individual response and how well you tolerate the treatment.