A trial of pembrolizumab with lenvatinib for kidney cancer (KEYNOTE-B61)

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 non-clear cell renal cell cancer (nccRCC)
• your kidney cancer has spread to nearby tissues or lymph nodes or your cancer has spread to somewhere else in your body (advanced or metastatic cancer)
• you have cancer that doctors can see on a scan
• you have a recent tissue sample available for the trial team to do some tests on or you are willing to give a new sample
• you are willing to use reliable contraception during treatment and for up to 4 months after if there is any chance you or your partner could become pregnant. Your doctor will let you know the exact length of time and about suitable contraception.
• You are fully active or can care for yourself but can’t carry on with all your normal activities or do active work (Karnofsky performance status of at least 70)
• your blood pressure  is well controlled. You can still take part if you are taking drugs to control your high blood pressure if you haven’t changed the dose in the week before you join the trial.
• you have satisfactory blood results within the 10 days before you start the trial drugs
• have good heart function
• you 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 cancer in the collecting ducts of the kidney. Your doctor can explain if this is the case for you.
• have cancer that is growing into, or very close to, a major blood vessel
• have cancer that has developed an area with a hole inside containing air (intratumoral cavitation)
• have had treatment that reaches your whole body (systemic treatment ) for your kidney cancer in the past. You might still be able to take part if you have had treatment before surgery (neoadjuvant ) or alongside surgery (adjuvant ) and this was over 12 months before taking part.
• have already had a drug very similar to pembrolizumab before, or any drugs that target T-cell receptors. Your doctor can explain more.
• have had radiotherapy in the 2 weeks before starting the study drug. If you have had less than 2 weeks of radiotherapy to help with some symptoms, you might just need to wait a week before starting the study drugs.
• have still got side effects from radiotherapy, including needing steroids to help or you have inflammation of your lung tissue (pneumonitis)  from radiotherapy 
• have had another trial drug or used a healthcare product as part of another clinical trial or study in the 4 weeks before the first dose of the study drug
• have had another cancer within the past 3 years that has been getting worse or needed treatment – apart from treated basal cell skin cancer , squamous cell skin cancer, or carcinoma in situ (CIS)  (for example breast CIS or cervical CIS).
• have active cancer in your brain or spinal cord (CNS). Or you have cancer that has spread to the layer of cells that cover and protect the brain and spinal cord. You might still be able to take part if you have had treatment for CNS disease in the past and you are well, you aren’t taking steroids and that cancer hasn’t got worse in the 2 weeks before starting the study drugs.

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

• have had major surgery in the 3 weeks before your first dose of the study drug
• have wounds from surgery that are not healing well
• have a high level of protein in your urine. You might need to collect your urine in a bottle for 24 hours to check. 
• have any stomach or gut problems that could make absorbing lenvatinib difficult
• have been coughing up bright red blood within the 3 weeks before your first dose of the study drug
• have an abnormal opening between two parts of the body or between the inside of the body and the outside (fistula)
• have an immune deficiency . Or you have been taking long term steroids that reach the whole body or any other drugs that lower your immune system, in the 7 days before the first dose of the trial drug.
• have an active autoimmune disease  which has required treatment reaching the whole body in the past 2 years. You can still take part if you take replacement therapy, such as insulin or steroids, if your body does not make enough. Your doctor can explain more.
• have inflammation of the lung tissue (pneumonitis) or if you have had pneumonitis which needed steroid treatment before
• have an infection needing treatment that reaches the whole body
• have HIV
• have hepatitis B or active hepatitis C
• have had an active tuberculosis  infection
• have any other medical problem, mental health condition or are taking any medication that the trial team think would affect you taking part
• have had a transplant with someone else’s tissue or organ

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

• are allergic to pembrolizumab or lenvatinib. Or you are allergic to anything the drugs contain.
• are pregnant or breastfeeding
• have had a live vaccine within 30 days before the first dose of the study drug