A trial looking at IMA901 vaccine and GM-CSF, with or without cyclophosphamide for advanced kidney cancer

Cancer type:

Kidney cancer
Renal cell carcinoma




Phase 2

This trial looked at a new vaccine treatment called IMA901 and the growth factor GM-CSF with or without one dose of cyclophosphamide for advanced kidney cancer.

Renal cell cancer is the most common type of kidney cancer. If it spreads to somewhere else in the body it can be difficult to treat. Doctors are always looking for new treatments, or new combinations of treatment that may work better.

IMA901 is a new vaccine treatment that is a type of immunotherapy Open a glossary item. This means it uses the immune system to kill cancer cells. IMA901 is an experimental treatment and researchers were not sure how well it would work.

In this trial, people had IMA901 with GM-CSF. This is a growth factor that is sometimes used after chemotherapy to increase the number of white blood cells in the body. We know from research that GM-CSF may help vaccines such as IMA901 be more effective. Doctors thought that giving GM-CSF shortly before IMA901 would help the vaccine to work better.

Doctors also thought that one low dose of cyclophosphamide Open a glossary item may help IMA901 to work better. But they were not sure.

In this trial, everyone had IMA901 and GM-CSF. Some people also had a single low dose of cyclophosphamide before the first IMA901 and GM-CSF injections.

The aims of this trial were to find out

  • If IMA901 stopped kidney cancer growing or made it smaller
  • If cyclophosphamide helped IMA901 to work better
  • If IMA901 could help people live longer
  • More about the side effects of IMA901

Summary of results

The trial team found that having cyclophosphamide before the vaccine helped IMA901 work better.

Of the 68 people this trial recruited, the researchers were able to look at the results of 64. Of these 64 people, 31 had a dose of cyclophosphamide before IMA901 and 33 did not.

Those who had cyclophosphamide before starting IMA901 lived longer than those who did not.

In general the people whose immune system responded to IMA901 in this trial lived longer than would be normally expected.

The most common side effects reported were

  •  Itching, reddening or swelling around the injection site
  • A high temperature – fever

The trial team concluded that having a single dose of cyclophosphamide before IMA901 helped it to work better. They say more trials should be done to look at 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.

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

Professor Arnulf Stenzl

Supported by

Experimental Cancer Medicine Centre (ECMC)

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

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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