A trial of selumetinib with dacarbazine for advanced melanoma in people with a BRAF gene fault

Cancer type:

Melanoma

Skin cancer

Status:

Results

Phase:

Phase 2

This trial looked at a drug called selumetinib alongside dacarbazine for people with melanoma that has spread to another part of the body. This is called advanced melanoma. It was for people whose melanoma cells have a change (mutation Open a glossary item ) in a gene called BRAF.

More about this trial

Doctors may treat advanced melanoma with chemotherapy. They usually use a drug called dacarbazine. But researchers are looking at ways to improve treatment. In this trial they looked at a drug called selumetinib alongside dacarbazine.

Selumetinib is a type of biological therapy called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The researchers compared selumetinib and dacarbazine with dacarbazine alone. The aims of the trial were to find out

If selumetinib and dacarbazine together worked better than dacarbazine alone for people with advanced melanoma whose melanoma cells have the BRAF gene mutation
More about the side effects

Summary of results

The trial team found that having selumetinib alongside dacarbazine extended the length of time before the cancer started to get worse by about 2½ months.

91 people who hadn’t had any other treatment for advanced melanoma took part in this trial.

45 had dacarbazine and selumetinib
46 had dacarbazine and a dummy drug (placebo)

The researchers looked at the average length of time people lived without any signs of their cancer getting worse. Researchers call this progression free survival. They found it was

Just over 5½ months for people who had dacarbazine and selumetinib
3 months for people who had dacarbazine

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The researchers also looked at how long people lived on average after treatment. Doctors call this overall survival. They found that the group who had dacarbazine and selumetinib lived a little longer, but the difference between the 2 groups could have happened by chance (the results were not statistically significant Open a glossary item )

People in the selumetinib group had more problems with feeling or being sick, a skin rash, diarrhoea and swelling of their hands and feet.

Despite causing more side effects, the trial team concluded that having dacarbazine alongside selumetinib improved progression free survival for people whose melanoma cells have a change in a gene called BRAF. But it did not affect the average length of time people lived after treatment (overall survival).

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.