
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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 . 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.
This trial has now finished recruiting people, but there are details of a related trial comparing the combination of dabrafenib and trametinib with another drug called vemurafenib elsewhere on the database.
You may be able to enter this trial if you
You cannot enter this trial if you
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 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.
You see the doctor to have some tests before taking part in this trial. These tests include
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.
Dabrafenib and trametinib are new drugs and there may be side effects we don’t know about yet. The most common side effects reported include
Your doctor will talk to you about other possible side effects before you agree to take part in the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Paul Nathan
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
National Institute for Health Research Cancer Research Network (NCRN)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”