A trial of pembrolizumab and olaparib for advanced pancreatic cancer (PemOla)

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 the most common type of pancreatic cancer called ductal adenocarcinoma of the pancreas that has spread to other parts of the body 
• have already had tests that confirm you have high levels of gene changes in the cancer cells or you have cancer that has DNA changes called microsatellite instability  high or mismatch repair deficiency . Your doctor will know this. 
• have had no more than one systemic treatment  for pancreatic cancer that couldn’t be removed with surgery. This was for cancer that may have spread to the large blood vessels near the pancreas, or to a several lymph nodes  (stage 3 cancer). Or for cancer that had spread to other parts of the body (stage 4 cancer). Your doctor will know this.
• have cancer that your doctor can see on a scan that hasn’t been treated with radiotherapy
• are fit and active but might not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results 
• are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
• 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 pancreatic cancer that can be removed with surgery or you have cancer that has spread only into the surrounding tissues but no further
• have cancer that has spread to the brain or spinal cord or the thin tissue layers that cover them. You can take part if you have had treatment, the cancer is stable and you have stopped taking steroids.
• have had more than one systemic treatment for pancreatic cancer that has spread to other parts of the body
• have had checkpoint inhibitors , immunotherapy  or a drug similar to olaparib in the past
• have another cancer that is getting worse or needed treatment within the last 3 years. You can take part if you have non melanoma skin cancer  or carcinoma in situ  that has been successfully treated. You can’t take part if you have early bladder cancer.
• have had another cancer in the last 2 years and you have not had treatment with the aim to cure
• have had radiotherapy within 2 weeks of starting trial treatment. You can’t take part if you still have side effects from radiotherapy or are taking steroids . You can take part if you have radiotherapy to help with symptoms within 1 week.
• are having treatment to help your body make blood cells. This includes G-CSF , GM-CSF  or erythropoietin . And you have this within 28 days of starting trial treatment. 

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

• have had treatment that damps down the immune system . This includes steroids unless it is a low dose.
• have myelodysplastic syndrome (MDS) , acute myeloid leukaemia (AML ) or your doctor suspects might have either of these
• have certain lung problems . Your doctor will know what these are. 
• have had a heart attack in the last 2 months or a significant heart problem  that needs treatment. The trial team check if you have a heart condition before you join the trial.
• have had a stroke  in the last 2 months
• have HIV, a hepatitis B or hepatitis C infection or any other severe infection that needs treatment
• have liver problems
• have an autoimmune condition  that needs treatment apart from certain ones. Your doctor will know about this.
• can’t swallow tablets or absorb medication
• take medication that affects substances in the body called CYP enzymes
• are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 28 days of being put in a treatment group for this trial.
• have had a transplant with someone else’s cells (an allogeneic transplant  or an organ transplant )
• have moderate side effects from past cancer treatments that aren’t getting better. This does not apply to hair loss.
• have another medical condition or mental health condition that could affect you taking part 

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

• have severe allergies or are sensitive to drugs  
• have had a severe allergic reaction to pembrolizumab or anything it contains 
• have had a live vaccine  within 30 days of the start of treatment. Please note that the approved COVID-19 vaccines are allowed as they aren’t live vaccines.
• are pregnant or breastfeeding or planning to become pregnant