A trial of MK-6482 for kidney cancer (MK-6482-005)

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 all of the following apply. You:

• have clear cell renal cell cancer that has spread to the surrounding tissue or to another part of the body and can’t be removed with surgery
• have had a scan  that shows the cancer has got worse during or after the last treatment and the doctor can measure the cancer on the scan
• have had an immunotherapy  drug and a growth blocker  drug to treat the cancer. Your doctor can tell more about this.
• are willing to use contraception during treatment and for a period of time after if there is any chance you or your partner could become pregnant
• can look after yourself but might not be able to do active work (Karnosfky performance score 70 to 100)
• have satisfactory blood test results
• 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 had more than 3 different treatments for your cancer
• have cancer that has spread to the brain or spinal cord unless it has been treated and is stable
• have had another cancer that has got worse in the past or needed treatment in the past 3 years apart from successfully treated non melanoma skin cancer  or carcinoma in situ
• have had growth factors  such as G-CSF or GM-CSF to help your body make more blood cells within 28 days of being put into a treatment group (randomisation ) in the trial
• have already had MK-6482, everolimus or similar drugs, your doctor will know about this
• have had radiotherapy within the 2 weeks before randomisation
• have had a monoclonal antibody  within the 4 weeks before randomisation 

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

• need to use oxygen or have a low level of oxygen in the blood – your doctor will do test for this
• have had a heart attack or chest pain (angina) within the 6 months of starting treatment or you have any other major heart problem
• have high blood pressure that isn’t controlled by medication
• have moderate to severe liver problems
• can’t swallow tablets or capsules
• have a problem with the digestive system  that affects how well your body absorbs medication
• have had major surgery within 3 weeks before randomisation or the wound has not healed well enough
• are taking medication or herbal treatments such as phenobarbital, enzalutamide, phenytoin or St Joh’s Wort that affect the CYP enzymes. You might be able to join if you can stop taking them. Your doctor can tell you more about this.
• are taking medication such as cyclosporin, ketoconazole or ritonavir that affects a protein called P-gp. You might be able to join if you can stop taking them. Your doctor can tell you more about this.
• have HIV, hepatitis B, hepatitis C, active tuberculosis (TB) or an active infection needing treatment
• have an immune system  that isn’t working well or are taking drugs such as steroids that damp down the immune system
• have another medical condition or mental health problem that your doctor or the trial team think could affect you taking part

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

• are taking an experimental drug or using an experimental device as part of another clinical trial
• have had a live vaccine  within 30 days of randomisation
• are pregnant or breastfeeding