A trial of nivolumab for advanced melanoma that has got worse despite other treatments (CheckMate 037)

Cancer type:

Melanoma

Skin cancer

Status:

Results

Phase:

Phase 3

Advanced melanoma means it is not possible to remove the melanoma with surgery, or it has spread to another part of your body. Doctors often treat advanced melanoma with chemotherapy or a biological therapy. But it may continue to grow despite having these treatments, and researchers are looking for ways to help people in this situation.

More about this trial

In this trial, they compared a drug called nivolumab with chemotherapy drugs that doctors already use to treat advanced melanoma. Nivolumab is a type of biological therapy called a monoclonal antibody.

People who took part in this trial had melanoma that had got worse since having treatment with a drug called ipilimumab (Yervoy), or another drug that works in the same way. If their melanoma had a certain change to a gene called BRAF, they must have also had a type of drug called a BRAF inhibitor such as vemurafenib or dabrafenib.

The aims of the trial were to:

see if nivolumab helps people with advanced melanoma more than chemotherapy
learn more about the side effects

Summary of results

This trial showed that nivolumab helped stop the melanoma growing, but it didn’t help people live longer.

The trial recruited 405 people with advanced melanoma skin cancer. They’d all had treatment for their melanoma already, but it had continued to grow.

The people taking part were put into 1 of 2 groups at random, and:

272 people were in the nivolumab group
133 people were in the standard treatment group (their doctor decided which treatment was best for them)

Some people didn’t go on to have treatment for a number of reasons, including people changing their mind. So 370 people had treatment as part of the trial:

268 out of 272 in the nivolumab group
102 out of 133 in the standard treatment group

The research team looked at how well the treatment worked. They found that there was a difference between the two groups. The cancer had got smaller in:

just under 3 in 10 people (27%) who had nivolumab
1 in 10 people (10%) who had standard treatment

study diagram

When they looked at how long it was until the cancer started to grow again, they found the most common length of time was:

3.1 months for those who had nivolumab
3.7 months for those who had standard treatment

study diagram

Then they looked at how long the people lived for, but there was only a small difference between the two groups. The most common length of time was:

15.7 months for those who had nivolumab
14.4 months for those who had standard treatment

study diagram

They also looked at how many people were living a year after starting treatment. They found this was also similar in the two groups:

just under 6 out of 10 (59%) of those who had nivolumab
just over half (55%) of those who had standard treatment

A similar number of people in each group had side effects. It was just under 8 out of 10 people (77%) who had nivolumab, and just over 8 out of 10 people (82%) who had standard treatment.

But more people in the standard treatment group had side effects classed as serious. This was more than 1 in 10 (14%) of those having nivolumab, and more than 3 in 10 (34%) of those having standard treatment.

The most common side effects of nivolumab were tiredness, itchy skin, diarrhoea, rash, feeling sick and a change in skin pigment (vitiligo).

The trial team concluded that nivolumab does stop melanoma growing in some people. However, it doesn’t appear to increase how long people with advanced melanoma live. It did cause fewer side effects than other treatments and is a useful treatment option for this group of people.

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.