A trial of lenvatinib and pembrolizumab for bowel cancer (LEAP-017)

The following bullet points are a summary of 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:

• have adenocarcinoma bowel cancer that has spread and cannot be removed by surgery (stage 4A, B or C)
• had previous treatment but your cancer has continued to grow or came back. You might be able to join if you could not tolerate having the standard treatment for bowel cancer.  
• have an area of cancer that the doctor can see and measure on a scan
• have a sample of tissue (biopsy)  taken before that the trial team can access or if not you are willing to have a fresh biopsy taken
• are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
• can swallow capsules or have liquid medication through a feeding tube
• have satisfactory blood test results
• are willing to use contraception during the trial and for a time after if there is any chance you or your partner could become pregnant
• are at least 18 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

• have a cancer that has a genetic change called microsatellite instability  and deficient mismatch repair (MSI-H/dMMR). Your doctor will test for this and know the results. 
• have a scan or x-ray that shows your cancer spread is very close to a major blood vessel or that there is very little blood going into the cancer   
• are coughing up blood if your cancer spread is in the lung or other cancer spreads are bleeding within 2 weeks of starting treatment
• have fluid on the lungs, around the heart or around the tummy (abdomen) that needs draining or drugs to control it within 2 weeks of joining the trial
• have cancer spread to the spinal cord, brain or the tissue surrounding the brain
• have had radiotherapy within 2 weeks of starting treatment. If it was to control symptoms such as pain (palliative radiotherapy) it is 1 week. You can’t join the study if you still have ongoing side effects from any previous radiotherapy. 
• had another cancer in the past 3 years that has got worse or needed treatment. This is apart from early cancers  treated with the aim to cure. And successfully treated non melanoma skin cancer  and in situ carcinoma  of the cervix or breast. 
• have already had treatment with certain checkpoint inhibitors  drugs, certain monoclonal antibodies  or VEGFR inhibitors. Your doctor will know if you have had any of these drugs. 
• have already had regorafenib or TAS-102
• have had any cancer treatment within 28 days of going into a trial treatment group (randomisation ) 
• have ongoing side effects from any previous treatment. This is apart from mild nerve damage and mild hormone (endocrine ) side effects that need treatment or you are taking hormones to replace what the body makes. 

Medical conditions
You cannot join this trial if any of these apply. You:

• have a problem with your digestive system  that affects how well your body absorbs capsules or tablets
• had a major heart problem  such as a heart attack, unstable chest pain (angina) or congestive heart failure in the past year 
• had a stroke in the past year
• have high blood pressure that isn’t controlled with or without medication. If you are taking medication there must no change to the dose within the week of randomisation.
• had a blood clot in an artery within the past year
• have a high amount of protein in your urine. Your doctor will test for this. 
• have a heart scan (ECHO  or MUGA ) that shows your heart isn’t working well enough. Your doctor will arrange these tests and will know what the results are. 
• have a wound that isn’t healing, an ulcer, a bone fracture or an active infection that needs treatment that reaches the whole body (systemic treatment )
• have HIV, hepatitis B or hepatitis C
• have had major surgery within 3 weeks of starting treatment
• have had medication that stimulates the immune system  such as G-CSF  within the 4 weeks before joining the trial. You might be able to join if you are taking regular erythropoietin  and the dose has stayed the same for the 2 months before starting trial treatment. 
• have an abnormal opening between 2 parts of the body or between the inside of the body and the outside of the body (a fistula) 
• have taken an experimental drug as part of a clinical trial within 28 days of starting this trial treatment
• are allergic to any of the drugs used in this trial or any of their ingredients
• have an active autoimmune disease  that has needed systemic treatment in the past 2 years. This is apart from hormone treatment that replaces what the body would make. 
• have an immune system that isn’t working well enough
• are taking medication that damps down the immune system. This is apart from a small daily dose of steroids. 
• have inflammation of the lungs or had inflammation of the lungs that was treated with steroids
• have any other medical condition or mental health problem that might affect you taking part in the trial

Other 
You cannot join this trial if any of these apply. You:

• have had a live vaccine  within 30 days of the start of treatment. Please note that the COVID-19 vaccine is allowed as it isn’t a live vaccine. 
• are pregnant or breastfeeding