A trial of Belzutifan (MK-6482) for kidney cancer (MK-6482-013)

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 renal cell cancer that contains the clear cell type and has spread outside the kidney to the surrounding tissue or to another part of the body (stage 4) 
• have cancer that the doctor can measure 
• have a sample of tissue (biopsy ) that the trial team can access. If this isn’t available you must agree to have a new sample taken. 
• have had at least 2 doses of PD-1 or PD-L1 treatment but no more than 1 course of treatment  with a PD-1 or PD-L1 drug for the cancer spread. Your doctor will know this.
• have had treatment for your cancer spread with a PD-1 or PD-L1 treatment. And during treatment or after treatment your cancer has got worse. 
• can take care of yourself but might not be able do your normal activities or do active work (Karnofsky performance score 70% or more)
• are willing to use contraception during treatment and for a while after if there is any chance you or your partner could become pregnant
• 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 cancer spread to the brain, tissue surrounding the brain or spinal cord. You might be able to join if you had treatment, it is stable and you aren’t taking steroids for at least 2 weeks before starting the trial treatment. 
• have had more than 3 different courses of treatment that affected the whole body (systemic therapy ) for your cancer spread 
• have ongoing side effects from previous treatment apart from certain side effects. Your doctor will know which ones these are. 
• have another cancer that has got worse or needed treatment within the past 3 years. You can join if you had successfully treated non melanoma skin cancer  or an in situ carcinoma . 
• have had belzutifan before or another drug that works the same way. Your doctor will know if you have. 
• have a certain type of targeted drug  within 2 weeks before going into a treatment group (randomisation ). Your doctor will know which type it is.
• have cancer treatment that reaches your whole body (systemic treatment) within 4 weeks of randomisation
• have radiotherapy within 2 weeks of starting the trial treatment or still have side effects. For radiotherapy for symptom control (palliative radiotherapy) it is 1 week. 

Medical conditions

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

• have lower level of oxygen in the blood. Your doctor will do a test for this. 
• need to use oxygen sometimes or all the time
• had a heart attack within the past 6 months or another heart problem  that could affect you taking part
• have moderate or severe liver problems
• had blood cell growth factors  such as G-CSF, GM-CSF or EPO within 28 days of starting the trial treatment
• have a problem with your digestive system  that means you are unable to take medication by mouth or you are unwilling to do so
• have major surgery within 3 weeks of starting the trial treatment
• are taking medications including herbal and complementary that strongly affect the CYP enzymes unless you can stop them during the trial. Your doctor will know which medications these are. 
• are taking experimental drugs or using a device as part of another clinical trial
• have an infection that needs treatment which reaches your whole body
• have HIV, hepatitis B, hepatitis C or active tuberculosis (TB)
• have a problem with your immune system  that means it isn’t working well enough
• have another medical condition or mental health problem that could affect you taking part

Other

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

• are sensitive or allergic to belzutifan or any of its ingredients
• pregnant or breastfeeding