A trial looking at intetumumab, with or without dacarbazine (DTIC), for advanced melanoma

Cancer type:

Melanoma

Skin cancer

Status:

Results

Phase:

Phase 2

This trial looked at intetumumab (also called CNTO 95), with or without dacarbazine (DTIC), for advanced melanoma skin cancer.

Doctors sometimes use dacarbazine to treat melanoma that has spread. It helps to control the growth of melanoma in some people. But unfortunately this is usually temporary and the cancer starts to grow again.

Intetumumab is a type of biological therapy called a monoclonal antibody. Intetumumab blocks the action of proteins called integrins. These are found on the surface of cells. Some cancers use these integrins to form new blood vessels so that they can get the food and oxygen they need to continue growing. Doctors hoped that if they can stop cancers from forming new blood vessels, this would slow or stop the growth of the cancer.

The aims of this trial were to find out

How well intetumumab works as a treatment for advanced melanoma
More about the side effects

Summary of results

The research team found that there was a possible small benefit with using intetumumab for advanced melanoma, but that more research needs to be done.

This trial recruited 129 people from the UK, America and Germany into 1 of 4 groups. The different groups had different doses of the trial drug.

Group 1 had dacarbazine and a dummy drug (placebo)
Group 2 had dacarbazine and intetumumab at a higher dose
Group 3 had intetumumab alone at a higher dose
Group 4 had intetumumab alone at a lower dose

The research team looked at how long it took for the melanoma to start growing again. The results showed that there was a small difference between the people who had dacarbazine and intetumumab (group 2) and the other groups. But the difference was not enough to be significant in statistical terms.

They also looked at how long people lived for. There was a small increase for the people who had the higher dose of intetumumab (groups 2 and 3) compared to the other groups. But again, it wasn't a big enough difference to be significant in statistical terms.

The most common side effects included headache, tiredness, sickness and pain at the injection site. These were mostly mild and affected people in all 4 groups. About 1 out of every 4 people who had intetumumab had temporary inflammation of the eye with the first cycle of treatment.

The research team concluded that although the results could have happened by chance (they weren't statistically significant Open a glossary item ), there was a general trend of improvement with intetumumab and it was safe to use. They suggest more research is done to investigate this further.

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.