
"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 whether having lenvatinib with pembrolizumab works better than pembrolizumab on its own as a treatment for head and neck cancer.
The trial is open to people who have one of following head and neck cancers:
Pembrolizumab is an immunotherapy. It works by stimulating your to help fight cancer. Doctors use pembrolizumab to treat cancer including some head and neck cancers.
Lenvatinib is a called a cancer growth blocker. It works by blocking signals that tell cancer cells to grow. Doctors use lenvatinib to treat some cancers but not head and neck cancers.
Researchers think that pembrolizumab with lenvatinib might work well to treat head and neck cancers. To find this out half the people in the trial have pembrolizumab and lenvatinib. And the other half have pembrolizumab and a dummy drug ().
The 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 you have one of the following head and neck cancers:
And all of the following apply:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This is an international phase 3 trial. The team need 500 people worldwide to join with 28 people from the UK.
This is a double blind randomised trial. You are put into treatment groups. Neither you nor your doctor can choose which group you are in. And neither you nor your doctor knows which group you are in. The treatment groups are:
You have pembrolizumab as a drip into a vein. You have . Each cycle is 3 weeks. You have pembrolizumab on the first day of each treatment cycle.
You have pembrolizumab for 2 years as long as it is working and the side effects aren’t too bad.
After the 2 years you might be able to have another year of pembrolizumab. Your doctor will talk to you about this.
You have lenvatinib or the dummy drug as a capsule. You take the capsule once a day every day.
You have lenvatinib or the dummy drug as long as it is working and the side effects aren’t too bad.
Research Samples
You give extra blood samples during the trial. Researchers use these to look for substances () to see how well the treatment is working.
They will also ask for a poo (stool) sample to look for biomarkers. You don’t have to give the poo sample if you don’t want to.
Quality of life questionnaires
You fill in 3 questionnaires:
The questions ask about:
This is a quality of life study.
You see the doctor to have some tests when you agree to take part. These tests include:
During treatment you see the doctor regularly for a physical examination and blood tests. At some of these visits you also have a heart trace and a CT scan or MRI scan.
You see the doctor at the end of treatment for:
You then see the doctor every 3 months until:
The trial team will then contact you about every 3 months to see how you are until:
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.
You have a card that shows you are taking part in this trial. On the card are the contact details of the trial team. Always carry this card with you. Show it to your GP when you see them or to staff at the emergency department of the hospital if you go there. This is so they can contact the trial team if necessary.
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 common side effects of pembrolizumab include:
The common side effects of lenvatinib includes:
Your doctor or a member of the trial team will talk to you about the possible side effects of treatment before you agree to take part.
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Kevin Harrington
Merck, Sharp & Dohme
Eisai
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.”