A trial of encorafenib, binimetinib and vemurafenib for melanoma (COLUMBUS)

Cancer type:

Melanoma
Secondary cancers
Skin cancer

Status:

Results

Phase:

Phase 3

This trial compared 2 drugs called encorafenib and binimetinib with vemurafenib for melanoma skin cancer.

This trial was for people with melanoma skin cancer that had spread to nearby lymph nodes Open a glossary item or to another part of the body (advanced melanoma). And whose melanoma cells had a change in the gene called BRAF.

More about this trial

Doctors use vemurafenib (Zelboraf) to treat people with advanced melanoma whose cancer cells have a change in the BRAF gene. Vemurafenib is a type of targeted cancer drug called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
 
Encorafenib and binimetinib are also targeted cancer drugs that block cancer growth. We knew from research that encorafenib and binimetinib might help people with advanced melanoma whose cells have the BRAF gene change.
In this trial the researchers compared vemurafenib with:
  • encorafenib with binimetinib
  • encorafenib on its own
The main aims of this trial were to find out:
  • which was the best for treating people with advanced melanoma
  • more about the side effects of encorafenib and binimetinib
  • what happened to encorafenib and binimetinib in the body

Summary of results

The trial team found that encorafenib with binimetinib could be a new treatment for people whose melanoma has a change in the BRAF gene. 
 
This trial closed in 2016. These results were published in 2018.
 
About this trial
This was a phase 3 trial. It was a randomised trial
 
There were 2 parts to this trial.
 
In the first part 577 people were put into 1 of 3 groups.
  • 192 people had encorafenib and binimetinib
  • 194 people had encorafenib
  • 191 people had vemurafenib 

Results
These are the results of the 1st part. When the results of the 2nd part are available we will update this summary.
 
The team looked at the number of people for whom the treatment worked. They found it was:
  • 121 people (63%) in the encorafenib and binimetinib group
  • 98 people (51%) in the encorafenib group
  • 77 people (40%) in the vemurafenib group 

They also looked at how well the treatment worked. 
 
They looked at how many people had no sign of their melanoma (a complete response), they found it was:
  • 15 people (8%) in the encorafenib and binimetinib group
  • 10 people (5%) in the encorafenib group
  • 11 people (6%) in the vemurafenib group
For those whose melanoma had shrunk (a partial response), they found it was:
  • 106 people (55%) in the encorafenib and binimetinib group
  • 88 people (45%) in the encorafenib group
  • 66 people (35%) in the vemurafenib group
For those whose melanoma had stayed the same (stable disease), they found it was:
  • 56 people (29%) in the encorafenib and binimetinib group
  • 65 people (34%) in the encorafenib group
  • 79 people (41%) in the vemurafenib group
After an average follow up of just over 16½ months (16.6 months) the researchers looked at the average length of time people were alive and free of cancer. They found that it was:
  • just under 15 months (14.9 months) for people in the encorafenib and binimetinib group
  • just over 9½ months (9.6 months) for people in the encorafenib group
  • just under 7½ months (7.3 months) for people in the vemurafenib group

Side effects
The number of people in each group who had severe side effects was:
  • 66 people (34%) in the encorafenib and binimetinib group
  • 65 people (34%) in the encorafenib group
  • 69 people (37%) in the vemurafenib group
The most common side effects reported in the encorafenib and binimetinib group included:
  • feeling and being sick
  • diarrhoea
  • tiredness
  • aching muscles
  • an increase in the amount of creatinine in the blood
  • constipation
  • headache
  • weakness
  • dry skin
  • rash
  • high temperature
  • an increase of an enzyme called GGT
  • hair loss
  • loss of muscle strength
  • high blood pressure
The most common side effects reported in the encorafenib group included:
  • feeling and being sick
  • tiredness
  • aching muscles
  • headache
  • dry skin
  • rash
  • hair loss
  • darkening of the skin
  • loss of muscle strength
  • pain, tingling and numbness in the hands and feet
  • diarrhoea
  • high temperature
  • an increase in an enzyme called GGT
  • thickening of the skin on the soles of the feet and palms of the hands
Conclusion
The team concluded that people who took encorafenib with binimetinib lived longer without a sign of their cancer when compared with those who took vemurafenib. 
 
This combination appears to have side effects that are more acceptable when compared with encorafenib only and vemurafenib only.  
 
Encorafenib with binimetinib is a new treatment choice for people with melanoma that has the BRAF gene change. And further studies are ongoing to find the best order to have treatment for melanoma. 
 
Where this information comes from
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 Mark Middleton

Supported by

Array Biopharma Inc
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Novartis

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11136

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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