A study of immunotherapy and targeted drugs for kidney cancer (sub study 03B)

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. You:

• have a type of kidney cancer called renal cell cancer that has spread into the surrounding tissue (locally advanced) or to another part of the body (metastatic). This is stage 4 renal cell cancer. 
• have had certain targeted cancer drugs and immunotherapy. And your cancer spread got worse during or after treatment. Your doctor will know which treatments these are and if you have had them.
• have an area of cancer that the doctor can measure
• can take care of yourself but might not be able to do all your normal activities or do active work (Karnofsky performance score 70 to 100)
• are able to swallow tablets
• have a previous tissue sample (biopsy ) the team can access. If this is not available you are willing to have a fresh biopsy taken.
• have satisfactory blood test results
• are willing to use contraception during treatment and for a time after if there is any chance you or your partner could become pregnant
• are at least 18 years old

You can join the trial if you are having medication such as bisphosphonates for your bones. This is as long as you started it at least 2 weeks before going into one of the trial treatment groups (randomised). 

Who can’t take part

Cancer related

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

• have cancer spread to the brain or spinal cord. You might be able to join if you have had treatment for this spread. Your doctor will be able to tell you more about this.
• have had a scan  that shows the cancer that is either very close to a major blood vessel or that the cancer has changed and looks like it is full of air or similar. Your doctor will know if your scan shows this. 
• have another cancer that has needed treatment or has got worse in the past 3 years. This is apart from non melanoma skin cancer  and any carcinoma in situ  (CIS) that has been successfully treated.
• have already had treatment or been put into a treatment group (randomised ) for another sub study that is part of the main study. Your doctor will know if you have.  
• have had an experimental drug or used a device as part of another clinical trial within 4 weeks of starting treatment
• have had radiotherapy within 2 weeks of starting treatment. Or you are having corticosteroids due to side effects from radiotherapy. 
• have had more than 4 cancer treatments that reach the whole body (systemic treatment)  
• have had belzutifan or a similar drug already. Your doctor will know if you have.  

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

• have heart problems  that could affect you taking part
• have high blood pressure that isn’t well controlled
• have major surgery within 3 weeks of starting treatment
• have more than a certain amount of protein in your urine. Your doctor will do a urine test for this.
• have lung problems  such as inflammation or fluid on the lung that could affect you taking part. You might be able to take part if you had treatment for fluid on the lung. Your doctor will know if this is so.
• are coughing up blood within the 3 weeks before starting treatment 
• have an inflammatory bowel disease such as irritable bowel syndrome (IBS) or Crohn’s disease
• 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). You might be able to join if it isn’t too bad. Ask your doctor they will know. 
• have a problem with your digestive system  which affects how well your body absorbs medication taken by mouth
• have an immune system  that isn’t working very well or you are taking medication that damps down the immune system within the 7 days of starting treatment. You can take steroids as long as it is a small dose. Your doctor will know what the dose is. 
• have an autoimmune disease  that has needed treatment in the past 2 years apart from certain ones. Your doctor will know which ones these are. 
• have HIV, hepatitis B or active hepatitis C. Or you have had any other infection that needs treatment.
• don’t have enough oxygen in your blood. Your doctor will test for this. Or you need to have oxygen to help you breath. 
• have had an organ transplant . Or you have had a stem cell or bone marrow transplant from a donor (allogeneic transplant ).
• have any other medical condition, mental health problem or social situation that could affect you taking part

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

• are allergic or sensitive to any of the treatments or any of their ingredients
• have a live vaccine  within the 30 days of starting treatment. You cannot have a live vaccine for 3 months after finishing treatment. The COVID-19 vaccines and some seasonal flu vaccines are not live vaccines.
• are pregnant or breastfeeding