A trial using circulating tumour DNA to work out when to switch between targeted treatment and immunotherapy for melanoma (CAcTUS)

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 can’t be removed with surgery or it has spread elsewhere in the body (stage 3 to stage 4 melanoma)
• have a change (mutation ) in the BRAF V600 gene on your melanoma cells 
• have at least one area of melanoma that your doctor can see and measure on a scan
• completed radiotherapy or radiosurgery  at least 2 weeks before you have the first dose of trial treatment if you had this 
• have satisfactory blood test results 
• are well enough to be up and about for at least half the day but you might not be able to work (performance status 0, 1 or 2) 
• 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 cancer that has spread to the brain or spinal cord or the tissues that surround the brain unless it isn’t causing symptoms, has been treated and is stable
• have had treatment for melanoma that can’t be removed by surgery or has spread elsewhere in the body.  Treatments may have included immunotherapy, targeted treatment, cancer vaccines or an experimental treatment.
• have already had treatment after surgery that included a combination of checkpoint inhibitors. For example you have had nivolumab and ipilimumab. 
• have cancer that has spread to the heart or the blood vessels and arteries that surround it
• have had another cancer unless there have been no signs of it for 3 years or you had a non melanoma skin cancer that was successfully treated 

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

• have an inherited condition that causes red blood cells  to break down. Your doctor will know this.  
• have an autoimmune condition apart from certain ones. Your doctor will know this. 
• have had treatment that damps down the immune system. This includes steroids within 2 weeks of starting trial treatment unless it was a low dose. 
• have scarring on the lungs that is causing symptoms or may interfere with picking up any lung side effects that trial treatment may cause
• have had medication that stops you having fits (seizures) in the month before starting trial treatment 
• have had a heart attack in the last 6 months, you have a fast heartbeat or you have another serious heart problem that needs treatment. You doctor checks if you have a heart condition before you can take part in the trial. 
• have high blood pressure and medication isn’t controlling it 
• have HIV or an active hepatitis B or hepatitis C infection
• have a change in electrolytes that can’t be corrected with medication 
• have or have had a blockage in a vein in your eye or have a risk of developing this. Symptoms include problems with your eyesight. Your doctor will know this. 
• have any other serious or uncontrolled medical condition or mental health problem that the trial team think would affect you taking part in the trial 

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

• are having treatment that can’t you have if you are in this trial. For example drugs to treat HIV or herbal medicine such as St John’s wort. 
• are allergic to any of the treatments in the trial or anything they contain 
• are pregnant or breastfeeding