
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new therapy called AGS-003 for kidney cancer that has spread.
Doctors may treat advanced kidney cancer with surgery followed by a biological therapy. The most common therapy they use is sunitinib (Sutent).
ASG-003 is made using a piece of your kidney cancer (removed during surgery) and white blood cells called monocytes. The researchers hope that this combination will stimulate your body’s immune system to attack the cancer cells.
In this trial the researchers will compare
The main aim of this trial is to find out if AGS-003 and sunitinib is better than sunitinib alone for kidney cancer that has spread.
You may be able to join this trial if all of the following apply. You
You cannot join this trial if any of these apply
This is an international phase 3 trial. The researchers need 450 people to join.
This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. But you will know which group you are in.
Before starting treatment with AGS-003, the trial team will collect some of your white blood cells. This is called leukapheresis. To make the AGS-003 therapy, they will use your white blood cells with some of your cancer tissue that was removed during surgery.
You have AGS-003 as an injection into the skin under your arm. This is called an intradermal injection. You will have an injection every 3 weeks for 5 doses, one dose at 6 weeks and then have booster injections every 3 months.
Sunitinib is a capsule. You can take them with or without food. You take them every day for 4 weeks and then have 2 weeks of not taking them.
You continue treatment as long as it is helping you and the side effects aren’t too bad.
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor every 3 weeks for 18 weeks to have a physical examination and blood tests. You have another CT scan or MRI scan at week 8, week 16 and then every 3 months.
At the end of treatment you see the doctor to have the same tests you had at the beginning.
After treatment you see the doctor every 3 months to see how you are. If you prefer this can be done over the telephone. You can talk to your doctor about this.
AGS-003 is a new therapy and there may be side effects we don’t know about yet. The most common side effects include
The most common side effects of sunitinib are
Your doctor will talk to you about the possible side effects before you agree to take part in the trial.
We have more information on sunitinib.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Tim Eisen
Argos Therapeutics
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.