A trial of dacarbazine and ipilimumab for stage 3 or 4 melanoma (CA184024)

Cancer type:

Melanoma
Skin cancer

Status:

Results

Phase:

Phase 3

This trial was looking at having ipilimumab alongside dacarbazine for advanced melanoma.

More about this trial

Doctors sometimes use chemotherapy to treat melanoma. You may have chemotherapy if melanoma has come back after having other treatment, or if melanoma cannot be removed by surgery when it is first diagnosed. This is called advanced melanoma. The drug that doctors most commonly use to treat advanced melanoma is called dacarbazine.

In this trial, they looked at having a drug called ipilimumab alongside dacarbazine. Ipilimumab is a type of biological therapy called a monoclonal antibody (MAB). The aims of this trial were to

  • Find out if dacarbazine and ipilimumab together worked better than dacarbazine alone
  • Learn more about the side effects

Summary of results

The researchers found that having ipilimumab with dacarbazine increased the length of time people lived after treatment. Doctors call this an improvement in overall survival.

The trial recruited 502 people who had melanoma that was stage 3 or 4. The people who took part had not had any other treatment for advanced melanoma.

The trial was randomised. This means the people taking part were put into 1 of 2 treatment groups at random. Neither they, nor their doctors could decide which group they were in.

  • 250 people were randomised to have dacarbazine and ipilimumab
  • 252 were randomised to have dacarbazine and a dummy drug (placebo)

The plan was for people to have 4 cycles of chemotherapy with ipilimumab (or placebo). When the trial team looked at how many people completed all 4 treatment cycles, they found this was

  • 92 people who had ipilimumab
  • 165 people who had the placebo

People in the ipilimumab group had more side effects such as diarrhoea, changes to the liver and skin rash or itching.

More people in the ipilimumab group stopped treatment early because of bad side effects. But overall, the most common reason people stopped having treatment before completing 4 cycles was because their melanoma had got worse.

The researchers looked at the average length of time people lived and found this was

  • Just over 11 months in the group who had ipilimumab
  • Just over 9 months in the group who had the dummy drug

They followed up the people taking part to see how many were still alive after 3 years and found this was

  • More than 1 in 5 (21%) of the people who had ipilimumab
  • Fewer than 1 in 8 (12%) of people who had the dummy drug

The researchers concluded that the people who had ipilimumab with dacarbazine lived longer on average than the people who had dacarbazine alone.

In 2015, the researchers published more results about long term survival. They found that after 5 years, the number of people still alive was

  • Nearly 1 in 5 (18%) of the people who had ipilimumab
  • Fewer than 1 in 10 (9%) of the people who had the dummy drug

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) and published in a medical journal. The figures we quote above were provided by the trial team. 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 Chris Price

Supported by

Bristol-Myers Squibb

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 1023

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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