A trial looking at dabrafenib, trametinib and vemurafenib for melanoma

Cancer type:

Melanoma
Skin cancer

Status:

Results

Phase:

Phase 3

This trial compared dabrafenib and trametinib with vemurafenib to treat melanoma that had spread to another part of the body. The trial was for people:

  • who hadn’t had treatment for advanced melanoma
  • whose melanoma cells had a change in a gene called BRAF

More about this trial

Dabrafenib, trametinib and vemurafenib are types of biological therapies Open a glossary item called cancer growth blockers. They stop signals that cancer cells use to divide and grow.

Different types of cancer growth blockers stop different signals in cancer cells. The researchers in this trial hoped that combining them might help them to work better. Early research also showed that dabrafenib and trametinib might be better than vemurafenib for this group of people. But the researchers wanted to find out more.

The main aims of the trial were to:

  • find out if dabrafenib and trametinib worked better than vemurafenib
  • learn more about the side effects

Summary of results

The trial team found that dabrafenib and trametinib worked better than vemurafenib for advanced melanoma with a change in the BRAF gene.

704 people took part. They were put into 1 of 2 groups at random.

  • 352 had dabrafenib and trametinib
  • 352 had vemurafenib

The trial team did an early analysis of the results. They looked at the how many people were alive 1 year after treatment. They found this was:

  • just over 7 out of 10 people (72%) who had dabrafenib and trametinib
  • just over 6 out of 10 people (65%) who had vemurafenib

The researchers also looked at the average length of time people lived without any signs of their cancer getting worse. This is called progression free survival. They found that on average, this was:

  • just over 11 months in the people who had dabrafenib and trametinib
  • just over 7 months in the people who had vemurafenib

Trial diagram

People who had dabrafenib and trametinib had more problems with high temperatures (fevers). People who had vemurafenib had more skin problems. These included

  • a rash
  • sensitivity to light
  • red and sore skin on the palms of the hands or soles of the feet
  • developing squamous cell cancer of the skin
  • thickening of the skin

The trial team concluded that dabrafenib and trametinib worked better than vemurafenib without causing more serious side effects. Based on this and another similar study (COMBI-D), the combination of dabrafenib and trametinib is now licensed and approved by The National Institute for Health and Care Excellence (NICE). It is now a usual treatment for this group of people.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Paul Lorigan

Supported by

Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9864

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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