A trial of pembrolizumab with olaparib for prostate cancer (KEYLYNK 010)

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
• have cancer that is getting worse while having hormone therapy or after surgery to remove the testicles within 6 months of randomisation into this trial. If you were having flutamide your cancer must have got worse 4 weeks or more after your last treatment. If you were having bicalutamide or nilutamide it must have got worse 6 weeks or more after your last treatment. 
• have a CT scan or MRI scan or bone scan  that shows your cancer has spread to another part of the body
• have had either abiraterone or enzalutamide
• have had docetaxel for prostate cancer that had spread and the cancer spread got worse during or after treatment
• are having treatment that stops the production of testosterone (anti androgens or luteinising hormone blockers) and your testosterone level in the blood is less than 50 ng/dL. If you are having luteinising hormone-releasing (LRHR) agonists or antagonists and have not had surgery to remove the testicles you must have started the LRHR 4 weeks before you go through randomisation for this trial
• have satisfactory blood test 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 fit and able to do all your daily activities but might not be able to do heavy physical work (performance status 0 or 1)
• have a sample of tissue (biopsy ) available of your cancer spread that was taken within the past year. If not you are willing to have a fresh sample done. You may still be allowed to join if you have an older sample available. 
• 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 areas of small cell type cancer in your prostate 
• have had both abiraterone and enzalutamide before  
• have cancer that has spread to your brain or spinal cord unless it has been treated and you’ve had a scan within 4 weeks of randomisation which shows there is no sign of it getting worse, you have no symptoms and have not needed steroids for 7 days before randomisation
• have cancer spread into the tissue covering the brain or spinal cord (carcinomatosis meningitis)
• have had radiotherapy within 2 weeks of randomisation. You must have no side effects from previous radiotherapy, must not be taking corticosteroids and have no lung inflammation caused by radiotherapy. For radiotherapy for symptom control (palliative radiotherapy) it is 1 week. 
• have had radium treatment or similar radioactive drugs to treat prostate cancer  
• have had treatment to slow or prevent bone damage such as a bisphosphonate or denosumab and the dose has not been the same for 4 weeks or more before randomisation  
• have had apalutamide or darolutamide, or enzalutmide for prostate cancer which is responding to hormone therapy (hormone sensitive prostate cancer)
• have had olaparib or another PARP inhibitor
• have had a monoclonal antibody (MAB) within 4 weeks of randomisation or still have side effects within 4 weeks of randomisation
• have ongoing moderate side effects from cancer treatment apart from hair loss (alopecia) or nerve damage (neuropathy)
• have another cancer that is getting worse or that has needed treatment in the past 3 years apart from successfully treated non melanoma skin cancer or carcinoma in situ
• have a myelodysplastic syndrome  (MDS) or  acute myeloid leukaemia  (AML) or symptoms which might indicate you have these conditions 
• have had a certain type of bone scan called a bone ‘superscan’

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

• have had growth factors  such as G-CSF or GM-CSF within 28 days of randomisation
• have an autoimmune disease that has needed treatment that reaches the whole body (systemic treatment) in the past 2 years apart from medication to replace substances in the body such as hormones for an underactive thyroid or insulin for diabetes 
• have a problem with your digestive system that affects how well it absorbs medication, such as an operation to remove part of the stomach or a stomach ulcer (peptic ulcer), in the past 3 months
• have a hereditary condition where your body is unable to absorb certain sugars such as galactose, lactose or glucose
• have inflammation of the lung (pneumonitis) that isn’t caused by an infection or you had pneumonitis in the past that needed treatment with steroids
• have an active infection including tuberculosis (TB) that needs treatment
• have HIV, hepatitis B or hepatitis C
• have a condition that affects the immune system
• are taking steroids of more than 10mg of prednisolone or any other medication that affects your immune system
• have had a fit (seizure) within 6 months of giving consent to take part in the trial (informed consent) or you have a medical condition that means you are more likely to have fits such as a cerebrovascular accident (CVA) or a mini stroke (TIA) 
• have fluid on the abdomen (ascites) or you have fluid on the lung (pleural effusion) that needs medical attention
• have had a loss of consciousness within the past year
• have symptoms of congestive heart failure 
• have had a heart attack or chest pain (angina) within 6 months of randomisation. You can take part if you had an operation to improve the blood flow in the vessels in your heart within 3 months of randomisation. 
• have an abnormal heart rhythm such as a fast or slow heartbeat that is affecting your daily life
• have moderate to severe heart block and don’t have a pacemaker 
• have low blood pressure, or you have high blood pressure that isn’t controlled by medication
• have had major surgery within 28 days of randomisation and you have not recovered from the side effects or complications
• have taken herbal products that might affect the prostate or lower the PSA such as saw palmetto within 4 weeks before randomisation
• have had treatment with a drug that blocks the proteins PD-1, PD-L1 or PD-L2 or a drug that stimulates or blocks T cells  of the immune system. Your doctor can tell you more about this. 
• have had a targeted drug  within 4 weeks of randomisation or you still have ongoing side effects apart from hair loss. Your doctor can tell you more about this.  
• are taking medication or herbal products that affect the CYP enzymes. You might be able to join the trial if you can stop taking these but there needs to be a number of weeks before stopping them and starting olaparib. You doctor can talk to you about this. 
• are taking finasteride, dutasteride or similar drugs, oestrogens or cyproterone acetate within 4 weeks of randomisation
• have had a bone marrow transplant using a donor’s bone marrow (allogeneic transplant), double umbilical cord transplant or a solid organ transplant
• have had a whole blood transfusion within 120 days of randomisation. For red blood cells on their own and or platelets on their own it is within 28 days of randomisation. 
• have had an experimental drug or used an experimental device as part of a clinical trial within 4 weeks of randomisation
• have moderate nerve damage (neuropathy) causing weakness, numbness, and pain apart from when caused by an accident
• have any other medical condition or mental health problem that your doctor or the trial team think might affect you taking part

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

• are sensitive or allergic to any of the drugs used in this trial or any of their ingredients
• are not able swallow tablets or capsules
• have had a live vaccine within 30 days of randomisation
• are expecting to father a child from when you join the trial, during and within 6 months (180 days) after your last treatment in the trial