A trial of pembrolizumab and chemotherapy for prostate cancer that has spread (KEYNOTE 921)

The following bullet points list the entry conditions for this trial. The trial doctor reviews the entry conditions to make sure you are suitable to join the 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:

• are a man 
• have adenocarcinoma  of the prostate that has spread elsewhere in the body 
• have cancer that can be seen on a scan and has spread to the bones or surrounding tissue. You will not be able to join the trial if the cancer has spread only to the lymph nodes  between the hip bones (pelvis )
• have prostate cancer that got worse in the last 6 months either while you were having hormone treatment or after you had surgery to remove the testicles  (the trial team can tell you more about this)
• had flutamide at least 4 weeks ago or bicalutamide or nilutamide at least last 6 weeks ago, if you had any of these three drugs before joining this trial
• have had treatment with only 1 of the following drugs such as abiraterone, enzalutamide, apalutamide or darolutamide and the cancer got worse after at least 8 weeks of treatment or you had to stop due to side effects but had treatment for at least 4 weeks
• have been on a stable dose of bisphosphonates  or denosumab for at least 4 weeks if you are taking one of these drugs
• have a sample of tissue available for the trial team to do some tests on 
• have satisfactory blood tests results
• are willing to use a condom during treatment and for 6 months after if there is any chance you can pass your ejaculate to another person of any sex. You should not store any sperm during treatment or for 6 months after 
• are well enough to carry out all your normal activities but you might not be able to do heavy physical work (performance status of 0 or 1) 
• are at least 18 years old 

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related
You:

• have cancer in the brain or spinal cord. You might be able to take part if you have cancer spread to your brain that has been successfully treated, has not got any worse in the last 4 weeks and you haven’t taken steroids for at least a week.
• have cancer spread to the membranes that surround the brain (carcinomatous meningitis)
• have already had treatment with pembrolizumab or similar drugs. Your doctor will be able to discuss this in more detail with you. 
• have had docetaxel or another chemotherapy drug in the past for prostate cancer that has spread 
• have had radioactive medicine for prostate cancer such as radium 223
• have had abiraterone, enzalutamide, apalutamide or darolutamide within 4 weeks of starting treatment in this trial or you still have moderate to severe side effects from these treatments apart from hair loss
• have had treatment with hormone drugs such as finasteride, dutasteride or cyproterone within the last 4 weeks
• have had treatment with a drug called ketoconazole for prostate cancer 
• had a type of bone scan called a ‘superscan’ bone scan
• have had any other cancer in the last 3 years that is getting worse or needs treatment apart from basal cell skin cancer , squamous cell skin cancer  or carcinoma insitu (CIS ) that has been successfully treated with surgery

Medical conditions
You:

• have a problem with your immune system  or you take a treatment such as steroids that is equal to more than 10mg of prednisolone a day or any another treatment that damps your immune system within 7 days of starting trial treatment 
• an active autoimmune condition  that needed treatment in the last 2 years apart from treatment to replace hormones  in the body
• had surgery in the last month and are not yet fully recovered
• have a problem with your gut (digestive system ) that would affect how you absorb the trial drug
• can’t swallow tablets or capsules 
• have an active infection including tuberculosis (TB)
• have lung inflammation (pneumonitis)  or had lung inflammation in the past which was treated with steroids.
• have moderate to severe tingling or numbness in your hands or feet unless it was due to an accident not treatment 
• have a build up of fluid in the tummy (abdomen) or on the lungs
• have a heart condition called congestive heart failure that is causing symptoms 
• have had a blood transfusion in the last 120 days or red blood cells  or platelets  within the last month 
• have had treatment to stimulate the bone marrow  to make blood cells (growth factors) within 1 month of starting trial treatment 
• have had monoclonal antibody  treatment within 4 weeks of joining a trial group or you have had one in the past and still have moderate to severe side effects 
• have had herbal medicines for example ‘saw palmetto’ within 4 weeks of joining a treatment group in this trial 
• take a medication that blocks an enzyme called CYP3A4 that you can’t stop while you take part in the trial 
• have had radiotherapy within 2 weeks of starting treatment. Your side effects from radiotherapy must be better and you must not have pneumonitis .
• have had treatment in another clinical trial within 4 weeks of starting trial treatment 
• have had a stem cell transplant  with someone else’s cells or an organ transplant  
• have HIV
• have an active hepatitis B or hepatitis C infection 
• have any other medical condition, mental health problem or problem with drugs and alcohol that the trial team think would affect you taking part in the trial  

Other

• You are allergic to pembrolizumab or anything it contains.
• You are allergic to docetaxel or polysorbate 80.
• You have had a live vaccination  in the last 30 days. 
• You and your partner are planning a pregnancy.