Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of IMA901 with sunitinib for advanced renal cell cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a vaccine called IMA901 alongside sunitinib for a type of kidney cancer called renal cell cancer. It is for people who have renal cell cancer that has spread into surrounding tissue or to another part of the body.
Renal cell cancer is the most common type of kidney cancer. If it cannot be removed with surgery, or has spread to another part of your body, you may have a drug called sunitinib. But researchers are looking for new treatments, or new combinations of treatment that may work better.
In this trial, they are looking at a new vaccine treatment called IMA901. It is a type of
Everybody taking part in this trial has sunitinib. Some people also have IMA901. The people who have IMA901 also have drugs called cyclophosphamide and GM-CSF. Cyclophosphamide is a type of chemotherapy. GM-CSF is a growth factor that is sometimes used to increase the number of white blood cells in the body. In this trial, GM-CSF and cyclophosphamide are given at lower doses than usual with the intention of helping the IMA901 vaccine to work better.
The aim of the trial is to see if having IMA901, GM-CSF and a single dose of cyclophosphamide alongside sunitinib helps people with advanced renal cell cancer more than sunitinib alone.
Who can enter
You may be able to enter this trial if you
- Have clear cell renal cell cancer that has spread into local tissue or to another part of your body and can be measured on a scan
- Are going to have sunitinib as your first treatment for kidney cancer that has spread
- Have satisfactory blood test results, including a test to show that you have a substance in your blood called HLA-A*02
- Are willing to use reliable contraception if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have cancer that has spread to your brain
- Have already had treatment that reaches your whole body (
systemic treatment) for kidney cancer that has spread - you can take part if you had treatment after surgery to remove cancer that had not spread outside your kidney ( adjuvant therapy), as long as this finished at least a year ago
- Have any other type of cancer that has spread to another part of your body (metastatic cancer) or that could affect how long you are likely to live
- Have had an experimental drug as part of another clinical trial in the last 4 weeks
- Have an
autoimmune diseasesuch as rheumatoid arthritis or multiple sclerosis
- Have an infection that needs treatment with antibiotics into a vein (intravenous antibiotics) or any other serious infection
- Have had a heart attack, heart pain (angina), a stroke, a blood clot, or surgery to bypass a blockage in an artery during the last year
- Have any other serious medical condition that the trial team think would make it unsafe for you to take part
- Are known to be HIV, hepatitis B or hepatitis C positive
- Are pregnant or breastfeeding
This is a phase 3 trial. It will recruit about 330 people in 11 different countries.
Everybody taking part has sunitinib tablets. After taking sunitinib for about 4 weeks, you are put into 1 of 2 treatment groups by a computer. This is called randomisation. Neither you nor your doctor can choose which group you are in.
About 198 people in group 1 will have the IMA901 vaccine as well as continuing to have sunitinib.
About 132 people in group 2 will carry on having sunitinib alone.
If you are in group 1, you have injections of IMA901 into the skin of your tummy (abdomen) or thigh. These are called intradermal injections. Before each injection of IMA901, you also have an intradermal injection of GM-CSF. You have the injections
- 3 times in the first week
- Once a week for the next 3 weeks
- Once every 3 weeks in the following 12 weeks
You have cyclophosphamide through a drip into a vein just once, 3 days before your first IMA901 injection. This takes about half an hour
Everybody taking part continues to take sunitinib tablets. You take them once a day for 4 weeks, followed by 2 weeks without treatment. Each 6 week period is called a cycle of treatment. You may have up to 18 cycles of treatment.
You will see the trial team and have a number of tests before you start the trial treatment. The tests include
You may also have an X-ray or bone scan.
If you are in group 1, you have 13 hospital visits during the trial treatment and 7 follow up visits.
If you are in group 2, you have 8 hospital visits during treatment and 7 follow up visits.
You have scans 2 and a half months and 5 months after starting sunitinib. You have a number of blood tests during the trial. The trial team will use some of these samples to look for substances called
You have follow up visits every 3 months for up to about 2 years. At each of these visits you will have
- A physical examination
- Blood and urine tests
- A CT or MRI scan
In earlier trials, the most common side effects of IMA901 and GM-CSF injections were
- Redness, swelling, itching, pain or hardening of the skin at the injection site
- High temperature (fever) or chills
- Feeling sick
- Tiredness (fatigue)
- Swelling (inflammation) of the
It is possible that you could have an allergic reaction to IMA901 or GM-CSF. You have to stay at the hospital for at least 2 hours after having the injections. If you have a reaction, this can be treated straight away.
In earlier studies when people have had a single dose of cyclophosphamide, there were not any bad side effects, but some people felt tired or a bit sick.
There is more information about the side effects of sunitinib on CancerHelp UK.
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.
Professor Tim Eisen
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)