A trial of AGS-003 for kidney cancer that has spread (ADAPT)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Kidney cancer

Renal cell cancer

Status:

Closed

Phase:

Phase 3

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

ASG-003 and sunitinib
Sunitinib alone

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.

Who can enter

You may be able to join this trial if all of the following apply. You

Have renal cell cancer that is mostly clear cell type and has spread to another part of your body
Were diagnosed less than a year ago
Are to have surgery to remove some or all of your cancer
Are able to have treatment after surgery that includes sunitinib
Are able to look after yourself but not able to do active work (Karnofsky performance status 70 and above)
Have recovered from previous radiotherapy or surgery apart from mild side effects or complications
Have satisfactory blood test results
Are willing to use 2 forms of reliable contraception during treatment and for a year afterwards if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot join this trial if any of these apply

Your renal cell cancer has spread to your brain
Your cancer is pressing against your spinal cord (spinal cord compression)
You have already had other treatments for your kidney cancer that reach your whole body (systemic treatment ) such as immunotherapy, chemotherapy or hormonal therapy
You are currently taking an experimental drug as part of another clinical trial
You have had another cancer in the past 3 years apart from non melanoma skin cancer and some early cancers that were successfully treated (the trial team can advise you about this)
You are planned, or may need, to have further surgery to manage your cancer within 4 weeks of taking part in this trial
You have certain serious heart problems (your doctor can tell about this)
You have had a problem with bleeding in the past 4 weeks
You have certain problems with your digestive system (your doctor can tell you about this)
You have a problem with your thyroid
You have an infection that your doctor thinks could affect you taking part in this trial
You have any other medical condition or mental health problem that your doctor thinks could affect you taking part in this trial
You are pregnant or breastfeeding

Trial design

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.

2 out of 3 people will have AGS-003 and sunitinib
1 out of 3 people will have sunitinib

11894 Trial Diagram

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.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

A physical examination
Blood tests
Heart trace (ECG )
Heart scan (ECHO or MUGA )
CT scan or MRI scan
Urine test

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.