A trial looking at bevacizumab after surgery for melanoma skin cancer (AVAST-M)

You can enter this trial if you

• Have been diagnosed with melanoma skin cancer that is stage 2B, 2C or 3 (your doctor will advise you on this)
• Have had surgery to remove your melanoma in the last 12 weeks
• Are well enough to take part in the trial
• Have satisfactory blood test results
• Are willing to use reliable contraception during the trial (and for some time after) if there is any chance you or your partner could become pregnant
• Are at least 16 years old

You cannot enter this trial if you

• Have melanoma that has spread elsewhere in your body, apart from the lymph nodes near the melanoma
• Have melanoma that could not be completely removed by surgery
• Have had chemotherapy, immunotherapy or hormone therapy for melanoma in the last 12 weeks
• Have had an experimental drug as part of another clinical trial in the last 4 weeks
• Have had any type of surgery in the last 4 weeks
• Have had any other cancer in the last 5 years apart from non melanoma skin cancer or another very early stage cancer (in situ cancer) which has been successfully treated
• Have problems with blood clotting
• Have taken aspirin or a drug to prevent blood clots called clopidogrel in the last week unless it was a low dose (it is important that you don't stop taking these drugs without speaking to your doctor)
• Have high blood pressure that is not controlled with medicine
• Have had a stroke or heart attack in the last 6 months
• Have unstable angina or another heart condition that is cause for concern
• Have a peptic ulcer or have ever had an abscess in your abdomen
• Have a broken bone or a wound that won’t heal
• Have any other serious medical condition
• Are pregnant or breastfeeding

This is a randomised trial. Everybody taking part will be put into one of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have regular check ups. This is currently the standard treatment after having surgery to remove high risk melanoma skin cancer.

If you are in group 2, you will have bevacizumab every 3 weeks. You will have this as an injection into a vein over 30 minutes. You will have up to 17 injections in total, so your treatment will last about a year.

During the trial, the doctors will ask you to fill in some questionnaires. These will ask about how you are feeling and any side effects you have. They are called quality of life studies.

If you take part in this trial, the researchers will get a sample of the tissue taken when you had your operation to remove the melanoma. This is because studying tissue samples helps them to learn more about melanoma and how it responds to treatment. If your melanoma comes back, the doctors will ask your permission to take another sample of tissue. If you have more surgery, they would be able to take this during your operation. Or, if you don’t have another operation, they may ask if they can take a biopsy. But you don’t have to give this extra tissue sample if you don’t want to.

The researchers will also ask your permission to take a number of blood samples when you go to your hospital appointments. This is so that they can study your blood and look at your DNA. If you do not want to give these extra blood samples for research, you don’t have to. You can still take part in the trial. The blood and tissue samples will be stored safely and may be used in the future, but only for research purposes.

You will go to the hospital to see the doctors and have a number of tests before you take part in the trial. These include

• Blood tests
• Chest X-ray
• Heart trace (ECG)
• CT scan or MRI scan

If you are in group 1, you will go and see the doctors 6 weeks after joining the trial, and again 6 weeks after that. Then you will see them

• Every 3 months for the next 2 years
• Every 6 months for the following 3 years
• Once a year for 5 years after that

If you are in group 2, you will go to the hospital every three weeks for treatment. At each visit, you will see the doctors, have blood and urine tests and then have the bevacizumab injection. After you finish your treatment, you will go and see the doctors as often as the people in group 1.

Some of the most common side effects of bevacizumab are

• Raised blood pressure
• Protein in the urine
• An increased risk of bleeding
• Slower wound healing

In earlier trials, most people have had bevacizumab in combination with chemotherapy. For these people, there was a small increase in the risk of having a stroke, heart attack or blood clot. But the researchers think the risk is lower when you have bevacizumab on its own.

A very small number of people have an allergic reaction to bevacizumab. This is very rare, but the trial team will monitor you closely when you have the injections and treat any symptoms straight away.

There is more information about other possible side effects of bevacizumab on CancerHelp UK.