
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing a drug called MK-6482 with everolimus for kidney cancer.
It is open to people with kidney cancer that has spread to another part of the body or to the surrounding tissue. And it can’t be removed with surgery.
Doctors use everolimus to treat advanced kidney cancer. Everolimus is a called a growth blocker. It works by blocking the growth of blood vessels to the cancer. This slows down the growth of the cancer.
MK-6482 is a targeted drug that is a growth blocker. It works in a different way to everolimus to slow down the growth of cancers.
Researchers think that MK-6482 might be better than everolimus. To find this out they will compare MK-6482 with everolimus. In this trial half the people will have MK-6482 and the other half will have everolimus.
The main aims of this trial are to find out:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase 3 trial. The trial team need 736 people worldwide to join with 45 people in the UK.
It is a randomised trial. There are 2 groups. Neither you nor your doctor can choose which group you are in.
Half the people have MK-6482. The other half have everolimus.
MK-6482 are tablets you take once a day every day.
Everolimus is a tablet you take once a day every day.
You continue having treatment for as long as it is helping and the side effects aren’t too bad.
During the trial you should not eat grapefruit or Seville oranges or drink the juice of these fruits. You should not take St John’s Wort as a tablet or a tea.
You have a card that says you are taking part in this trial. Always carry this card with you as it has important information about the trial.
Quality of life
You fill in a few questionnaires before you start treatment and then at:
The questions ask about your:
These are quality of life questionnaires.
Research samples
You give a fresh tissue sample () before starting treatment. If this isn’t possible the team will ask for a sample of tissue from a previous biopsy. They will use this sample to learn more about kidney cancer.
You give blood samples before starting treatment and a number of times during treatment. Your doctor will tell you how often this is. They will use these samples to find out more about kidney cancer and about what happens to MK-6482 in the body.
You see the doctor to have tests before taking part. These include:
During treatment you see the doctor at:
You have more scans during treatment. Your doctor will tell you when and how often.
You see the doctor at the end of treatment. Then you see them 30 days later or before you start another cancer treatment which ever one comes first.
After treatment, if your cancer has not got worse you continue to have scans every 8 weeks or 12 weeks. Your doctor will tell you about this.
The trial team will follow you up every 3 months until your cancer gets worse or you start another treatment.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of MK-6482 are:
We have information about everolimus and its side effects.
Your doctor or a member of the trial team will talk to you about the possible side effects of the treatments before you agree to join the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Naveed Sarwar
Merck Sharp & Dohme (UK) Limited
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”