A trial looking at lenvatinib and pembrolizumab for people with advanced solid tumours (LEAP-005)

Cancer type:

Bile duct cancer
Biliary tree cancers
Bowel (colorectal) cancer
Brain (and spinal cord) tumours
Breast cancer
Ovarian cancer
Secondary cancers
Stomach cancer

Status:

Open

Phase:

Phase 2
This trial is for people with one of the following solid tumours Open a glossary item
  • breast cancer whose cells don’t have receptors for the protein Her2  Open a glossary itemand the hormones oestrogen and progesterone (triple negative breast cancer) 
  • ovarian cancer
  • stomach cancer 
  • bowel cancer
  • a type of brain tumour called glioblastoma multiforme (GBM)
  • bile duct cancer
  • gallbladder cancer 
It is for people whose cancer continued to grow or spread to other parts of the body despite treatment (advanced solid tumours). 

More about this trial

Treatment for advanced solid tumours is usually a combination of cancer drugs. The exact treatment you have depends on your cancer type and how well you are overall. 
 
Researchers are looking for new ways to help people with advanced solid tumours. In this trial, they are looking at 2 targeted drugs called lenvatinib and pembrolizumab. Both drugs are already a possible treatment for people with certain types of solid tumours.
 
Targeted drugs work by ‘targeting’ differences that a cancer cell has that make them different from normal cells. Lenvatinib (Lenvima) is a type of targeted drug called a cancer growth blocker. It blocks certain proteins that help cancer cells to grow new blood vessels. All cancer cells need blood vessels to survive and grow. 
 
Pembrolizumab is a type of cancer drug called a monoclonal antibody. It helps the immune system  Open a glossary itemattack the cancer and stop it from growing.
 
The main aims of this trial are to:
  • find out how well lenvatinib and pembrolizumab work as a treatment for advanced solid tumours
  • learn more about the side effects

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 1 of the following types of cancer:
As well as 1 of the above, all of the following must apply:
  • your cancer has spread to other parts of the body (metastatic) or continued to grow despite treatment 
  • doctors think that you can’t have treatment to cure your cancer 
  • you have at least 1 area of cancer that can be seen and measured on a scan 
  • you are willing to have a sample of cancer taken (biopsy Open a glossary item) if there isn’t a suitable sample available
  • you are at least 18 years old 
  • you have satisfactory blood test results 
  • your heart is working well and your blood pressure is normal 
  • you are well enough to carry out your normal activities apart from heavy physical work (performance status of 0 or 1
  • you are willing to use reliable contraception during treatment and for at least 4 months afterwards if there is any possibility that you or your partner could become pregnant 
As well as the above, there might be specific entry conditions for your cancer type. Speak to your doctor or research nurse if you want to find out more about the entry conditions for this trial.
 
Who can’t take part
You cannot join this trial if any of these apply:
 
Cancer related
  • you have cancer spread in your brain or spinal cord unless you have had treatment, it has been stable for the past month and you have stopped taking steroids more than 2 weeks ago
  • you have a tumour in your brain stem 
  • you have cancer spread in the thin layers (membranes) that surround the brain (carcinomatous meningitis
  • your cancer has spread to a major blood vessel Open a glossary item and your doctor thinks that you have a high risk of bleeding 
  • you have had lenvatinib, pembrolizumab or any other similar drug 
  • you have had anti cancer treatment that reached your whole body in the last month 
  • you have had radiotherapy in the past 2 weeks and still have moderate or severe side effects from it, or you have had radiotherapy in the past week if it was radiotherapy to help with symptoms (palliative)
  • you still have moderate or severe side effects from previous anti cancer treatment, unless it is numbness and tingling in fingers and toes  
  • you have had another cancer in the past 3 years unless it was non melanoma skin cancer or a carcinoma in situ Open a glossary item of the cervix and breast 
Medical conditions
You cannot join this trial if any of these apply. You:
  • are taking part in another clinical trial or have taken part in a trial looking at a new drug or device in the last month 
  • take or have taken drugs that damp down your immune system such as steroids in the past week unless it was a very small dose 
  • have an autoimmune disease Open a glossary item that needed treatment that reached your whole body (systemic) in the past 2 years unless it was treatment to replace something that the body makes such as thyroxine or insulin 
  • have or have had lung problems such as pneumonitis Open a glossary item
  • have an active infection that needs antibiotics that reach your whole body (systemic) 
  • have problems with your gut and can’t absorb capsules 
  • have protein in your urine 
  • have coughed up a large amount of blood in the past 2 weeks 
  • have heart problems such as an abnormal heart rhythm, congestive heart failure, angina Open a glossary item that isn’t stable or you have had a heart attack in the past year 
  • have had a blood clot in one of the main blood vessels in the past year  
  • have a wound or a break in a bone (fracture) that hasn’t healed 
  • have had a drug that encourages the bone marrow to make white blood cells in the last 2 months such as G-CSF
  • have had an organ transplant  Open a glossary itemfrom a donor
  • have HIV 
  • have hepatitis B or hepatitis C 
  • have active tuberculosis
  • have any other serious medical condition or mental health problem that the trial team think could affect you taking part 
  • take an amount of drugs or alcohol that is a concern for your doctor
Other
You cannot join this trial if any of these apply. You:
  • are sensitive to any of the drugs used in this trial or anything they contain  
  • have had a live vaccine in the last month  
  • are pregnant or breastfeeding  
As well as the above, there might be specific exclusion conditions for your cancer type. Speak to your doctor or research nurse if you want to find out more about the exclusion conditions for this trial.

Trial design

This is an international phase 2 trial. Researchers hope that around 180 people worldwide and 18 people from the UK will agree to take part.
 
Everyone taking part has lenvatinib and pembrolizumab in the following way: 
  • you have pembrolizumab as a drip into your bloodstream (intravenously) every 3 weeks. It takes about 30 minutes to have pembrolizumab each time
  • you take lenvatinib capsules every day
You continue to have treatment for as long it is helping you and the side effects aren’t too bad. You can have up to 35 treatments of pembrolizumab, taking about 2 years in total. You may be able to continue to take lenvatinib after 2 years. Your doctor can tell you more about this. 
 
Quality of life
Everybody taking part completes quality of life questionnaires before the start of treatment and:
  • every 3 weeks during treatment 
  • at the end of treatment 
  • a month after finishing treatment 
The questionnaires ask about how you have been feeling and what side effects you have had. 
 
Blood test
You have extra blood tests as part of this trial. You have them before the start of treatment and then:
  • at set times during the trial
  • at the end of treatment 
Researchers want to:
  • look for certain proteins (biomarkers Open a glossary item) that can help to tell how well the treatment is working
  • find out what happens to the drugs inside your body (pharmacokinetics Open a glossary item)
  • look at the cancer DNA Open a glossary item
Tissue sample
The trial team will ask to use a tissue sample of your cancer taken when you had surgery or a biopsy. You need to have a new sample taken if there isn’t a suitable sample available. 
 
Researchers want to look for certain biomarkers in the cancer. 

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:
  • a physical examination 
  • heart trace (ECG Open a glossary item)
  • a heart scan (MUGA Open a glossary item  or ECHO Open a glossary item)
  • blood tests
  • urine test
  • a CT scan or MRI scan 
During treatment, you see the trial team every 3 weeks. You have blood tests and a physical examination every time you see them. 
 
You have a CT scan or MRI scan every 9 weeks for a year. You then have a CT scan or MRI scan every 3 months. If you have glioblastoma multiform (GBM), you have an MRI scan of your brain every 6 weeks, for 4 months. You then have an MRI of your brain:
  • every 9 weeks for a year
  • then every 12 weeks for a year
This continues for as long as the treatment is helping you and the side effects aren’t too bad. 
 
When you finish treatment, you see the trial team after a month. You then see or speak with the trial team every 3 months. 

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the treatment. 
 
Pembrolizumab and lenvatinib affect the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. Side effects can happen during treatment or some months after treatment has finished. 
 
The most common side effects of pembrolizumab are:
  • skin rashes, itching and changes to your skin colour 
  • loose or watery poo (diarrhoea)
  • cough 
  • pain in your joints, back and tummy (abdomen)
  • high temperature (fever)
  • low levels of thyroid hormones in your body causing tiredness, weight gain and feeling cold 
  • low levels of salts in your body that can cause muscle cramps and feeling sick
We have more information about the possible side effects of pembrolizumab.
 
The most common side effects of lenvatinib are:
  • a stroke Open a glossary item or bleeding in the brain that might cause numbness or weakness on one side of your body 
  • a blood clot in the veins of your legs or lungs
  • heart problems such as palpitations Open a glossary item, or a heart attack 
  • an abnormal opening (fistula) between organs or to the outside of your body 
  • a hole in your bowel (bowel perforation)
  • bleeding from the gut 
  • feeling or being sick
  • diarrhoea
  • loss of fluid in your body (dehydration)
  • shortness of breath 
  • liver problems that can cause yellowing of the skin and eyes (jaundice), tiredness and fever
  • changes in your brain that can cause confusion, sleepiness (drowsiness) and loss of consciousness due to severe liver problems      
  • kidney problems that can cause a reduction in the amount of urine you make and swelling of your legs, ankles and feet (kidney failure)

Location

Cambridge
Leicester
London
Manchester
Sutton

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Juanita Lopez

Supported by

Merck, Sharp & Dohme
Eisai

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16261

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think