A trial looking at pembrolizumab and enzalutamide with hormone therapy for prostate cancer (KEYNOTE-991)

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 adenocarcinoma of the prostate that has spread to the bones or organs  
• have had a scan  that shows where the cancer has spread to 
• have satisfactory blood tests results
• are willing to take hormone therapy during the trial or to have had surgery to remove your testicles 
• have a sample of tissue (biopsy ) from where the cancer has spread that the trial team can ask for or if this isn’t the case you are willing to have a fresh biopsy taken
• are active but might not be able to do heavy physical work (performance status 0 or 1)
• are willing to use a condom when having sex with anyone else and not donate sperm during the study and for at least 120 days after your last trial treatment
• 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 small cell prostate cancer 
• have cancer that has spread to the lymph nodes  only
• have or might have cancer spread to the brain or spinal cord
• have had certain previous treatments for your prostate cancer spread. Your doctor can tell you about this. 
• have already had hormone treatment for more than 3 years and 3 months (39 months) or you have had hormone treatment within 9 months of randomisation  or your disease has gotten worse while you were on hormone treatment
• have had treatment with a newer type of hormone treatment such as abiraterone, enzalutamide, apalutamide or doralutamide 
• are having bone restoring drugs such as bisphosphonates  or denosumab unless you have been on a stable dose for at least 4 weeks before randomisation in this trial
• have had another cancer in the past 3 years that has got worse or needed treatment apart from successfully treated non melanoma skin cancer  or a carcinoma in situ

Medical condition

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

• have had treatment for an autoimmune disease  in the past 2 years unless it was treatment to replace something the body produces such as hormones for thyroid problems or insulin for diabetes
• have an immune system that isn’t working well (immunodeficiency) or you are taking a large dose of steroids or another medication that affects your immune system within 7 days of the first dose of treatment
• have major surgery within 28 days of randomisation and you have not recovered from any side effects or complications
• have a problem with your digestive system  that affects how well your gut absorbs medication
• are not able to swallow tablets or capsules
• have an active infection that needs treatment that reaches your whole body
• have HIV, hepatitis B or hepatitis C
• have inflammation of the lung (pneumonitis) that isn’t caused by an infection or you had treatment (steroids) for it in the past
• have had or might have fits (seizures) or you have had loss of consciousness within the past year
• had a heart attack or uncontrolled chest pain (angina) in the past 6 months or another heart problem that might affect you taking part
• have or have had a history of other heart problems. Your doctor can review this with you. 
• have high blood pressure (hypertension) or low blood pressure (hypotension) that isn’t controlled
• are allergic to the treatments or any of their ingredients used in this trial
• have had treatment that stimulates the immune system (an immunotherapy drug)
• have taken herbal preparations such as saw palmetto that affects PSA levels within 4 weeks of randomisation
• are taking certain drugs that affect testosterone such as finasteride, dutasteride or cyproterone acetate within 4 weeks of randomisation
• are taking an experimental drug or using a device as part of another clinical trial within 4 weeks of randomisation 
• have had a type of bone scan called a superscan bone scan
• have had a bone marrow or stem cell transplant from someone else (allogeneic transplant) or you have had an organ transplant
• have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part
• have a live vaccine  within 30 days of randomisation