A trial of ipilimumab after surgery for stage 3 melanoma (CA184-029, EORTC 18071)

Please note this trial is no longer recruiting patients.

This trial is looking at a new drug called ipilimumab after surgery to remove melanoma.

Doctors usually treat melanoma with surgery. But if you have stage 3 melanoma, it is considered to be at high risk of coming back. Doctors want to find out if having more treatment after surgery helps to reduce the risk of the melanoma coming back.

Ipilimumab is a type of biological therapy called a monoclonal antibody (MAB). Researchers think that ipilimumab may help to stop melanoma coming back. But they don’t know for sure. All treatments have side effects, and it is important that people don’t have treatment they don’t need.

This trial will compare ipilimumab with a dummy drug (a placebo). The aims of the trial are to

Find out if ipilimumab helps to stop or delay melanoma coming back after surgery
Learn more about the side effects

Recruitment

Start 01/06/2008

End 29/07/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with stage 3 melanoma
Have had the melanoma completely removed with surgery in the last 6 to10 weeks
Have satisfactory blood test results and tests show that your heart is working well
Are well enough to take part in this trial (performance status of 0 or 1)
Are at least 18 years old
Are willing to use reliable contraception during the trial and for 12 weeks after treatment if there is any chance you could become pregnant. If appropriate, you will have regular pregnancy tests during the study

You cannot enter this trial if you

Have mucosal melanoma, melanoma of the eye, or your doctors don’t know where your melanoma started
Have melanoma that has spread from where it started to anywhere else in your body
Have had radiotherapy to the area where the melanoma was or where you have had lymph nodes removed
Have had interferon or any other treatment for melanoma apart from surgery
Are taking steroids long term or you take drugs that damp down your immune system (it is important that you don’t stop taking steroids without talking to your doctor)
Have had ipilimumab, or drugs called CD137 agonists, CTLA-4 inhibitors or CTLA-4 agonists in the past
Have had an experimental drug as part of another clinical trial in the last 4 weeks
Have had a vaccine to prevent an infectious disease in the last 4 weeks
Have had another cancer in the last 5 years, apart from carcinoma in situ of the cervix or non melanoma skin cancer that have been successfully removed with surgery
Have had your spleen removed, have had radiotherapy to the spleen in the past or you have low immunity
Have any sort of autoimmune disease
Have an infection that cannot be controlled with medication, or any other condition that could make it unsafe for you to take part in this trial
Are HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding

Trial design

The trial will recruit 950 people. It is a randomised trial. The people taking part will be put into one of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither you nor your doctor will know which group you are in either. This is called a ‘double blind’ trial.

There are 2 phases of treatment in this trial. The induction phase lasts for nearly 6 months. And the maintenance phase lasts for up to 3 years.

People in group 1 will have ipilimumab every 3 weeks through a drip into a vein (an infusion) 4 times during the induction phase. And then once every 3 months during the maintenance phase. The infusion takes about an hour and a half each time.

People in group 2 will have the same number of treatments, taking the same amount of time. But they have a dummy drug (a placebo) instead.

Everybody taking part will be asked to fill out a questionnaire before starting treatment, each time you have treatment and then every 3 months for up to 2 years. The questionnaire will ask you about any side effects you have had and about how you have been feeling. This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Blood and urine tests
Heart trace (ECG)
CT scan or MRI scan
Pregnancy test (for women)

You go to the hospital for treatment 4 times during the induction phase. At each visit you have a physical examination, a urine test, blood tests and a CT or MRI scan if needed.

During the maintenance phase, you go to hospital for treatment every 3 months for up to 3 years. You will have a physical examination, CT or MRI scans, blood tests and pregnancy tests if appropriate. You will also have regular eye tests.

After you finish treatment, you will see the trial team and have a blood test about 10 weeks later. Then you will see the doctors for follow up appointments every 3 months for 3 years and every 6 months after that. It may be necessary for you to have more hospital visits than this.

Side effects

Ipilimumab is a new drug and there may be side effects that doctors don’t know about yet. From earlier trials, doctors know that the possible side effects include