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