A trial comparing trametinib with chemotherapy for melanoma that has spread

Cancer type:

Melanoma

Skin cancer

Status:

Results

Phase:

Phase 3

This trial looked at a new drug called trametinib (GSK1120212) for advanced melanoma. It was for people with a change in a gene called BRAF in their melanoma cells.

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

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

In this trial, researchers looked at a drug called trametinib which blocks MEK and can stop melanoma cells growing. It is called a MEK inhibitor.

This trial was for people who had melanoma that had spread to lymph nodes (stage 3C) or to another part of the body (stage 4). This is called advanced melanoma. Doctors can use chemotherapy to treat advanced melanoma, but they are looking for ways to improve treatment.

The aims of the trial were to see

If trametinib was better than chemotherapy for people with advanced melanoma
How trametinib affected quality of life

Summary of results

The trial team found that trametinib was better than chemotherapy for advanced melanoma with a change in the BRAF gene.

This was a phase 3 trial. It recruited 322 people. It was a randomised trial. The people who took part were put into 1 of 2 groups by a computer

214 people had trametinib
108 people had chemotherapy

The trial team looked at the average length of time it took for melanoma to come back. For those who had trametinib it was just under 5 months. For those who had chemotherapy it was 1½ months.

After treatment the team looked at how many people had no sign of cancer (a complete response Open a glossary item ) or melanoma that had shrunk (a partial response ). They found that

22 out of every 100 people (22%) who had trametinib had cancer that had disappeared or shrunk
8 out of every 100 people (8%) who had chemotherapy had cancer that had disappeared or shrunk

At 6 months after treatment, the team looked at how many people were alive. They found that

81 out of every 100 people (81%) who had trametinib were alive
67 out of every 100 people (67%) who had chemotherapy were alive

The most common side effects of trametinib were

Skin rash
Diarrhoea
Swelling of the arms and legs due to extra fluid in the body
Tiredness

The most common side effects of chemotherapy were

The trial team concluded that trametinib was better than chemotherapy for treating advanced melanoma. And that further studies should be done to find the best role for trametinib in treating advanced melanoma.

We have based this summary on information from the team who ran the trial. 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. We have not analysed the data ourselves.