
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at comparing lenvatinib on its own with lenvatinib and pembrolizumab for advanced liver cancer.
Advanced liver cancer is liver cancer that has spread into the near by tissues or to another part of the body.
Lenvatinib is a targeted drug called a cancer growth blocker. Doctors can use lenvatinib to treat advanced liver cancer.
Pembrolizumab is an immunotherapy called a monoclonal antibody (MAB). Pembrolizumab works by stimulating the to fight cancer cells.
Researchers are always looking to improve treatment. They think that adding pembrolizumab to lenvatinib might be better for people with advanced liver cancer.
To find out if it is better half the people in this trial will have lenvatinib and pembrolizumab. The other half will have lenvatinib and a dummy drug ().
The aims of this trial are to find how:
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
You cannot join this trial if any of these apply.
Cancer related
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 team need 750 people worldwide to join with 30 people form the UK.
This is a randomised trial. Everyone is put into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The groups are:
Lenvatinib is a capsule. You take it once a day. Your doctor will tell you how many to take. You take the capsules at home apart from the days you have pembrolizumab or the dummy drug. On these days you take the lenvatinib capsule at the hospital about an hour after pembrolizumab or the dummy drug.
You have pembrolizumab or the dummy drug as a drip into a vein. You have it every 3 weeks. It takes about 30 minutes to have.
You continue to have lenvatinib as long as it is helping and the side effects aren’t too bad. You continue to have pembrolizumab or the dummy drug for up to 2 years as long as it is helping and the side effects aren’t too bad.
You have a card that says you are taking part in this trial. It has information about the trial and contact numbers of the trial team. You should always carry this card.
Samples
You give several blood samples throughout the trial. Researchers will use these to find out what happens to lenvatinib and pembrolizumab in the body when they are taken together. They will also look for substances () in the blood that might show how well treatment is working.
You give a poo (stool) sample before starting treatment then:
Researchers will use this sample to look for substances (biomarkers) that might show:
You don’t have to give this poo sample if you don’t want to. You can still take part in the trial.
Quality of life
You fill in a few questionnaires before starting treatment then
The questions ask about:
You see the doctor to have some tests before you start. These tests include:
During treatment you see the doctor every 3 weeks for:
When you finish treatment you see the doctor for a physical examination and blood tests. You then see the doctor a month and 2 months later:
Your doctor will then tell you how often they want to see you.
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 can affect the immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.
If you have any of these side effects, you should tell the doctor or nurse as soon as possible that you are on or have been on an immunotherapy.
The most common side effects of pembrolizumab are:
Lenvatinib can cause some serious side effects that can be life threatening and might need urgent medical attention. You need to tell your doctor straight away if you have any of the following side effects.
The most common serious side effects of lenvatinib are:
Other common side effects include:
Your doctor or a member of the trial team will talk to you about the side effects of lenvatinib and pembrolizumab before you agree to take part in this trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Daniel Palmer
Merck Sharp & Dohme Ltd
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”