A trial of pembrolizumab before surgery for bowel cancer (NEOPRISM-CRC)

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 adenocarcinoma  of the bowel. This includes rectal cancer if you won’t need to have chemoradiotherapy  before surgery.
• have cancer that may have spread to nearby lymph nodes  or to surrounding tissue. But it hasn’t spread to distant parts of the body. This is stage 2 to stage 3 cancer.
• have cancer that is microsatellite instability high (MSI high ) or mismatch repair deficient (MMRd) . Your doctor will know this.
• are well enough to have surgery with the aim to cure followed by chemotherapy
• 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 cancer spread to the brain or spinal cord 
• have cancer that has spread elsewhere in the body or into the lymph nodes around the abdomen (peritoneum )
• are going to have radiotherapy
• have had pembrolizumab in the past or a similar drug 
• have had another cancer drug in the 4 weeks before you join the trial
• have moderate to severe side effects from past treatment that aren’t getting better. You can join if you have hair loss or numbness and tingling in your hands or feet (peripheral neuropathy ).
• have or had another cancer that could affect the assessments doctors do to check if treatment is working
• are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 28 days of joining this trial.

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

• have a problem with how your kidneys and liver work
• have had a severe skin reaction to other drugs that stimulate the immune system
• have an autoimmune condition  that needs treatment apart from certain ones. Your doctor will know about this.
• have or had scarring on the lungs or active inflammation of the lungs (pneumonitis ) that needs or needed treatment
• have HIV, hepatitis C, an active hepatitis B infection, tuberculosis or any other active infection that needs treatment into the bloodstream. You might be able to take part if your hepatitis is controlled with medication. 
• have had a stem cell transplant with somebody else’s cells (allogeneic transplant ) or you have had an organ transplant  in the past
• have inflammation of the lining of your tummy or abdomen (peritonitis) because you have developed a hole in your bowel where the cancer is
• have a blocked bowel and you haven’t had treatment 
• have a problem with how your immune system works or are having treatment that damps down the immune system. This includes steroids within 7 weeks of starting trial treatment unless it was a low dose.
• have any other medical condition, mental health problem or a problem with drugs and alcohol that would affect you taking part 

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

• are allergic to pembrolizumab or anything it contains
• have had a live vaccine  within 30 days 
• are pregnant or breastfeeding