A trial looking at pembrolizumab and lenvatinib for head and neck cancers (LEAP-010)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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:
- mouth cancer (oral cancer)
- cancer of the back of the mouth (oropharyngeal cancer) caused by the
human papilloma virus 
(HVP) - cancer of the voice box (laryngeal cancer)
More about this trial
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:
- how safe it is to have pembrolizumab and lenvatinib
- how well this combination works
- how it affects
quality of life
Who can enter
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:
- mouth cancer (oral cancer)
- cancer of the back of the mouth (oropharyngeal cancer) and you have test results that show the
human papilloma virus (HVP) caused your cancer - cancer of the voice box (laryngeal cancer)
And all of the following apply:
- Your type of cancer is a
squamous cell cancer. - You can’t have surgery or radiotherapy with the aim to cure your cancer. If your cancer is newly diagnosed it must have spread from where it started (advanced cancer) and to at least 1 other area of the body.
- Your doctor can see and measure your cancer on a scan.
- The trial can get a sample of cancer tissue from when you were diagnosed or if this isn’t available you are willing to have a new sample (
biopsy ) done. - Your cancer has a large amount of the PD-L1 protein.
- You are active and able to look after yourself (performance status 0 or 1).
- You have satisfactory blood test results.
- You are willing to use reliable contraception during treatment and for a certain time after if there is any chance you or your partner could become pregnant.
- You are at least 18 years old.
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
- can have surgery or radiotherapy with the aim to cure your cancer
- had treatment that reaches your whole body (
systemic treatment ) with the aim to cure your cancer and the cancer came back or got worse within 6 months of finishing treatment - have cancer that has grown into the surrounding tissue and you had systemic treatment for it and the last dose was less than 6 months ago
- have signs or symptoms that mean your cancer has bled within 6 months of going into a treatment group
- have a scan that shows your cancer is growing into a major blood vessel
- have cancer that has spread to your brain or spinal cord unless you have had treatment, a scan shows it is stable, there are no signs of it getting worse for 4 weeks and you haven’t needed steroids within the 2 weeks of starting treatment
- have had radiotherapy to your head and neck before this includes the
lymph nodes around your collar bone - have cancer that has broken through the skin and caused ulcers or wounds on your skin
- have had another cancer that has started to get worse. Or you have needed to have treatment for cancer within the past 3 years apart from successfully treated
non melanoma skin cancer or a carcinoma in situ.
Medical conditions
You:
- have high blood pressure that isn’t controlled within the week before starting on the trial
- are allergic to pembrolizumab, lenvatinib or any of their ingredients
- have an abnormal opening between 2 parts of your body. Or between the inside of your body to the outside that is causing problems and needs surgery. This opening is called a fistula.
- have any problems with absorbing medicines. This might be because of a problem with your stomach or because you have had surgery to your stomach or bowel.
- have had a major heart problem in the past year that isn’t controlled by medication. This includes heart failure, heart attack, chest pain (angina) or abnormal heart rhythm.
- have had a test that shows our heart doesn’t work well enough
- had major surgery within 3 weeks of starting treatment
- have problems swallowing capsules or liquid medicines. This includes through a tube that goes down your nose to your stomach (
nasogastric tube ). Or a feeding tube that goes straight into your stomach through your abdomen (gastronomy tube) unless it is a certain size. - have had pembrolizumab or lenvatinib before
- have had a drug treatment that travels throughout the body (systemic treatment) such as chemotherapy within 4 weeks of starting treatment
- have had an experimental drug or used an experimental device as part of a clinical trial within 4 weeks of starting treatment
- have had radiotherapy within 2 weeks of starting treatment
- still have ongoing side effects from radiotherapy
- have an
immune system that isn’t working well enough - are taking 10mg or more of steroids within 7 days of starting treatment
- are taking medication that affects how well your immune system works, or have taken it within 7 days of starting treatment
- had systemic treatment for an
autoimmune disease within the past 2 years apart from medication to replace substances in the body for example thyroxine for thyroid problems, insulin for diabetes and steroids for problems with the adrenal glands - have inflammation of your lungs not caused by an infection (pneumonitis) or you had pneumonitis and you took steroids for it
- have an active infection that needs systemic treatment
- have HIV
- have hepatitis B or hepatitis C
- have had tuberculosis (TB)
- had an organ transplant
- had a bone marrow or stem cell transplant from another person (
allogeneic transplant ) - have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part
Other
You:
- have had a
live vaccine within 30 days of starting treatment - are pregnant or breastfeeding
Trial design
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:
- pembrolizumab and lenvatinib
- pembrolizumab and a dummy drug (
placebo )
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:
- before each treatment
- at the end of treatment then
- a month later
The questions ask about:
- your general health
- what daily activities you can do
- any symptoms or side effects you might have
This is a quality of life study.
Hospital visits
You see the doctor to have some tests when you agree to take part. These tests include:
- a
physical examination - blood tests
- urine test
- mouth examination
- heart trace (
ECG ) - heart scan (
ECHO or MUGA ) - CT scan or MRI scan
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:
- a physical examination
- blood tests
- CT scan or MRI scan
- heart trace
- heart scan
You then see the doctor every 3 months until:
- your cancer starts to get worse or
- you start another treatment for your cancer or
- the end of the trial
The trial team will then contact you about every 3 months to see how you are until:
- the end of the study or
- you decide to withdraw from the study
Side effects
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:
- itching, rash, loss of skin colour
- diarrhoea
- a cough
- joint pain
- back pain
- high temperature (fever)
- tummy (stomach) pain
- less hormones being made by your thyroid gland (hypothyroidism) causing tiredness, weight gain, feeling cold and constipation
- low level of salt in your blood causing tiredness, confusion, headaches, muscle cramps and or feeling sick
The common side effects of lenvatinib includes:
- bleeding in the brain (stroke or mini stroke) causing numbness and weakness on one side of the body
- blood clot in your legs (DVT) causing swelling, a warm feeling and tenderness
- blood clot in your lungs (pulmonary embolism) causing shortness of breath, rapid breathing, chest feeling tight, chest pain, cough, coughing up blood, fast heartbeat, blue lips
- heart problems including fast heart beat (palpitations), heart attack or your heart not being able to pump very well causing shortness of breath
- an abnormal opening (fistula) between parts of the body or to the outside of your body such as between the windpipe and the skin or between the bowel and the gut
- bleeding in the gut causing black, tarry poo or blood in the poo
- low level of fluid in your body (dehydration)
- changes to how your kidneys work causing diarrhoea and feeling or being sick
- changes to how your liver works causing yellowing of the skin and eyes (jaundice), tiredness, feeling sick, loss of appetite, tummy (abdominal) pain and fever
- changes to how your brain works causing confusion, feeling drowsy, poor concentration and loss of consciousness
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:
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Kevin Harrington
Supported by
Merck, Sharp & Dohme
Eisai
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
