A trial of IMA901 with sunitinib for advanced renal cell cancer

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 disease such 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

Trial design

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.

Hospital visits

You will see the trial team and have a number of tests before you start the trial treatment. The tests include

• Physical examination
• Blood and urine tests
• Heart trace (ECG)
• CT scan or MRI scan

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 biomarkers. This will not affect your treatment, but may help doctors in the future to work out who is most likely to benefit from the trial treatment. At some hospitals, researchers will also use blood samples to see how your immune system is responding to the injections.

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

Side effects

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 lymph nodes

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.