A trial of encorafenib and binimetinib for melanoma that has spread (PREMIUM)

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this trial if all of the following apply. You:

• have melanoma that has spread to the lymph nodes (stage 3 melanoma) or other parts of the body (stage 4 melanoma). If you have stage 4 melanoma it has only spread to one other part of the body.  And it can be completely removed by surgery. 
• have cancer that is possible to remove with surgery 
• have a change (mutation)  in the BRAF V600 gene in your melanoma cells
• have melanoma that your doctor can measure on a scan and this is the area that the surgeon will remove 
• have had scans to assess the cancer within 28 days of being put into a treatment group 
• have a sample of tissue from when you were diagnosed that the trial team can access. The team plan to do some tests on the sample. 
• can swallow medication 
• are fully active but might not be able to do heavy physical work (performance status 0 to 1)
• have satisfactory blood test results 
• are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant  
• are at least 18 years old 

Who can’t take part

Cancer related 
You cannot join this trial if any of these apply. You:

• have melanoma that didn’t start in the skin 
• have already had treatment after surgery for melanoma 
• have had encorafenib, binimetinib, dabrafenib, trametinib or similar drugs in the past  
• have had radiotherapy to the area of cancer that the surgeon will remove 
• have had an immunotherapy within 3 months of joining the trial 
• have melanoma that has spread to the brain or bone
• have had another cancer drug within 28 days of joining this trial 
• have had another cancer within 2 years of joining the trial. And this cancer hasn’t gone away completely or you might need more treatment.
• are taking part in another clinical trial that involves a treatment

Medical conditions
You cannot join this trial if any of these apply. You:

• have a serious problem with your eyesight
• have high blood pressure that isn’t well controlled with medication
• have had a heart attack in the last 6 months or have another significant heart problem  that needs treatment
• have had a stroke in the last 6 months
• have a serious condition that affects the muscles such as muscular dystrophy 
• have an autoimmune condition  apart from certain ones. Your doctor will know this. 
• have HIV, an active hepatitis B or hepatitis C infection or another serious infection 
• have any other medical condition or mental health problem that the trial team think could affect you taking part

Other
You cannot join this trial if you are pregnant, planning to become pregnant or breastfeeding.