A trial looking at dabrafenib and trametinib for advanced melanoma

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Melanoma

Skin cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at 2 new drugs called dabrafenib and trametinib for advanced melanoma. It is for people whose melanoma cells have a change in a gene called BRAF.

The BRAF gene affects how cells divide and grow. In some people the gene is changed or damaged. This is called a gene mutation Open a glossary item . About half of all people with melanoma have a BRAF gene mutation in their cancer cells. Dabrafenib is a type of BRAF inhibitor.

If the BRAF gene is faulty, it affects a protein called mitogen activated protein kinase (MEK). MEK is also involved in cell division, and can make cancer cells keep dividing out of control. Trametinib is a type of MEK inhibitor.

We know from research that both of these drugs may be used to treat melanoma with the BRAF mutation. We also know from research that together these 2 drugs may be better.

The researchers want to compare dabrafenib only with dabrafenib and trametinib to find out which is better to treat advanced melanoma with the BRAF mutation.

Who can enter

You may be able to enter this trial if you

Have melanoma that has spread to nearby lymph nodes and can’t be removed with surgery (stage 3C) or has spread to another part of your body (stage 4)
Have melanoma with a BRAF gene mutation – the trial team will test for this
Have melanoma that can be measured on your skin or on a scan
Have satisfactory blood test results
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Are willing to use reliable contraception during treatment and for up to 4 months afterwards if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have melanoma that has spread to your brain – you may be able to join if you have had surgery to remove the melanoma or scans show that it has been stable for the past 3 months, you have no symptoms and have not needed steroids or a particular type of medicine to prevent fits (seizures) in the past month
Have already had a BRAF inhibitor or MEK inhibitor
Have already had treatment for your advanced melanoma
Have had major surgery or extensive radiotherapy in the past 3 weeks
Have had any other cancer apart from non melanoma skin cancer that has been removed with surgery or another cancer that has been successfully treated and there has been no sign of it in the past 3 years
Have had a heart attack in the past 6 months or any other serious heart problem or have a pacemaker
Are HIV, hepatitis B or hepatitis C positive
Have had an experimental drug as part of another clinical trial in the past month
Have any other medical condition that could affect you taking part in this trial
Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. It will recruit 340 people from different countries around the world. This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.

People in group 1 have dabrafenib and trametinib. People in group 2 have dabrafenib and a dummy drug (placebo).

Dabrafenib and trametinib for advanced melanoma trial diagram

Dabrafenib is a capsule. You take 4 capsules daily with a glass of water. Trametinib and the dummy drug are tablets. You take 3 tablets daily with a glass of water. You continue treatment as long as it is helping you and the side effects are not too bad.

The trial team will ask you to fill out a questionnaire before you start treatment and then every 2 months for a year, every 3 months until treatment stops and then 5 weeks after your treatment ends. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

If you agree to take part in this study, the researchers will ask for some extra samples of tissue. If you don’t want to give these tissue samples, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

A physical examination
Blood tests
CT scan or MRI scan
Heart scan (ECHO )
Heart trace (ECG )
Eye test

During treatment you see the doctor every 4 weeks.

After treatment your doctor will tell you how often they want to see you. A member of the trial team will contact you every 3 months to see how you are.