A trial of IMA901 with sunitinib for advanced renal cell cancer (IMPRINT)

Cancer type:

Kidney cancer

Renal cell cancer

Status:

Results

Phase:

Phase 3

This trial looked at a vaccine called IMA901 alongside sunitinib for renal cell cancer (kidney cancer) that has spread.

More about this trial

Renal cell cancer is the most common type of kidney cancer. When this trial was done, doctors often used a targeted cancer drug called sunitinib to treat renal cell cancer that had spread.

In this trial, they wanted to see if having a vaccine called IMA901 as well as sunitinib would be useful. IMA901 is a type of immunotherapy. It helps the body’s immune system recognise and kill cancer cells.

In this trial people either had:

sunitinib alone
sunitinib, IMA901, a chemotherapy drug called cyclophosphamide and a growth factor called GM-CSF

Doctors hoped that a low dose of cyclophosphamide and GM-CSF would help the IMA901 work better.

The main aim of this trial was to see if IMA901 and sunitinib work better than sunitinib alone, for people with advanced renal cell cancer.

Summary of results

The research team found that the combination of IMA901 and sunitinib did not work better than sunitinib alone for renal cell cancer that had spread.

This trial was open for people to join between 2010 and 2012, and the research team published the results in 2016.

About this trial
Everyone taking part in this trial had a type of kidney cancer called renal cell cancer that had spread. They had not had any treatment before this.

They all had sunitinib for 4 weeks to begin with, and 339 people were put into 1 of 2 groups at random:

204 were in the sunitinib and IMA901 group
135 were in the sunitinib group

8577-randomisation.png

Results
In 2015 the research team looked at how many people in each group had died. They found it was:

101 out of 204 people (50%) in the sunitinib and IMA901 group
54 out of 135 people (40%) in the sunitinib group

The difference between the 2 groups is not big enough for the researchers to say for sure that it is due to the different treatments. It may have been chance.

They also looked at how many people’s cancer responded to treatment, and how long it was before the cancer started to grow. These were nearly the same in both groups.

The research team took blood samples to measure how much people’s immune system responded to the treatment. They couldn’t find a link between the number of immune system cells and how well the treatment worked for individual people.

Side effects
Some people taking part did have side effects, but many were mild or short lived. A few people had more severe side effects including increased blood pressure and a drop in red blood cells or white blood cells.

Most of the side effects people had were the usual side effects of sunitinib. Some people who had IMA901 had some redness or itching at the injection site.

Conclusion
The research team concluded that the combination of IMA901 and sunitinib was not better than sunitinib alone for renal cell cancer that has spread. But even when a trial shows a treatment isn’t useful for a particular cancer, it adds to our knowledge and understanding of cancer and how to treat it.

They suggest further work is done on how to increase the immune system response to IMA901.

Where this information comes from
We have based this summary on information from the research team. 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 who did the research. We have not analysed the data ourselves.