
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
The main study (KEYMAKER-U03) is looking at combinations of immunotherapy and targeted drugs for a type of kidney cancer called renal cell cancer.
Sub study 03A is part of the main study. It is open to people with a type of kidney cancer called renal cell cancer that has:
Doctors can treat advanced renal cell cancer with the combination of pembrolizumab and lenvatinib.
Pembrolizumab is an immunotherapy. It works by helping the to find and attack cancer cells.
Lenvatinib is a called a cancer growth blocker. It works by stopping:
This stops the cancer cells from growing.
In this sub study the study team are looking at the following drugs:
Belzutifan is a drug doctors use to treat people with an condition called
and renal cell cancer.
MK-4280A, MK-1308A and MK-7486A are combinations of pembrolizumab and another immunotherapy.
The main aims of the sub study are to find out:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. You:
You can join the trial if you are having medication such as bisphosphonates for your bones. This is as long as you started it at least 2 weeks before going into one of the trial treatment groups (randomised).
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You have:
Medical conditions
You cannot join this study if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
This an international phase 1/2 study. The team need up to 390 people to take part with 27 people from the UK.
It is a randomised study. A computer puts you into treatment groups. Neither you nor your doctor chooses which group you are in. There are 5 treatment groups:
Pembrolizumab and lenvatinib is the . The other groups are the test (
) groups. You have a higher chance of going into one of the experimental groups than the control group.
You have the following as a drip into a vein:
You have pembrolizumab and MK-1308A once every 3 weeks or 6 weeks. You have them for up to 2 years.
You have MK-4208A and MK-7684A once every 3 weeks for up to 2 years.
Lenvatinib and belzutifan are tablets. You take the tablets once a day. Your doctor will tell how many to take and whether you take them on an empty stomach or with a meal.
You continue to have treatment as long as it is helping and the side effects aren’t too bad.
Samples for research
You give extra blood samples and tissue samples () as part of the study. Where possible the team take these samples when you have blood tests and tissue samples taken as part of your routine care.
The team use these samples to:
This can help researchers to find out:
They might also ask to store your samples for researchers to use in the future. Your samples will be anonymous.
You see the doctor to have tests before taking part. These tests include:
You see the doctor regularly during treatment. This is:
You have a scan at 3 months and then every 6 weeks while having treatment. If a scan shows your cancer is getting worse your doctor will talk to you about whether you should continue with the study treatment. They will also speak to you about what other treatments there might be if you do stop having the study treatment.
If you are having lenvatinib you will have regular heart traces and heart scans done. Your doctor will tell you how often you are to have them.
You see the doctor at the end of treatment and a month later. This is to see how you are and to ask about any side effects.
After treatment if your cancer has not got worse you see the doctor every 6 weeks or 12 weeks. You also have a scan.
If your cancer has got worse the doctor or nurse will contact you at least every 12 weeks to see how you are.
You might continue to see the doctor as part of study for up to 5 years.
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.
Pembrolizumab, MK-1308A, MK-4280A and MK-7684A can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
Researchers have looked at the combination of pembrolizumab and lenvatinib in other clinical trials. The side effects of these 2 drugs are the same whether you take them together or separately. The most common side effects from having pembrolizumab in combination with lenvatinib are:
MK-1308A is a new drug and there might be side effects we don’t know about yet. The most common side effects we do know of are:
MK-4280A is a new drug and there might be side effects we don’t know about yet. The most common side effects we do know about are:
Doctors use belzutifan to treat renal cell cancer that has a link to Von Hippel-Lindau syndrome. But not for renal cell cancer by itself so there might be side effects we don’t know about yet when treating renal cell cancer only. The most common side effects of belzutifan we do know about are:
MK-7684A is a new drug and there might be side effects we don’t know about yet. The most common side effects we do know about are:
You might have reactions while you are having MK-7648A. These include:
Tell your nurse if you have any of these when having MK-7648A.
We have more information about:
Your doctor will talk to you about the possible side effects and will answer any of your questions before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Balaji Venugopal
Merck, Sharp & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.