A trial comparing pembrolizumab with other immunotherapies for bowel cancer that has spread (MK-1308A-008)

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 bowel cancer that has spread to another part of the body 
• haven’t yet had treatment for advanced bowel cancer
• have microsatellite instability high (MSI H) or mismatch repair deficiency (dMMR) in the bowel cancer genes. Your doctor will test for this. 
• have cancer that your doctor can measure on a scan 
• are well enough to carry out all your normal activities but might not be able to work (performance status 0 or 1)
• have a sample of tissue available that the trial team can access or you are willing to give a new sample 
• are willing to use reliable contraception during the trial and for a period after if there is any chance that you or your partner could become pregnant 
• have satisfactory blood test results 
• are at least 18 years old 

Who can’t take part

Cancer related 
You cannot join this trial if any of the following apply. You: 

• have cancer that has spread to the brain or spinal cord unless it has been treated and is stable 
• have already had an immunotherapy
• have had another cancer drug including an experimental drug within 4 weeks of starting trial treatment 
• have side effects from past treatments unless they are mild. This doesn’t apply if you have numbness or tingling in your hands or feet. 
• have had radiotherapy within 2 weeks of starting trial treatment or within 1 week if you had radiotherapy for symptoms  caused by cancer. If you had radiotherapy you must have recovered from the side effects and not need to take steroids to treat them.
• have another cancer that is getting worse or needed treatment in the last 2 years. You can take part if you had successfully treated non melanoma skin cancer , polyps  in the bowel or carcinoma in situ  of the breast or cervix.
• are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 4 weeks of being put in a treatment group for this trial.

Medical conditions 
You cannot join this trial if any of the following apply. You have:

• had a heart attack or significant heart problem  that needs treatment in the last 6 months. The trial team check if you have a heart condition before you join the trial. 
• an autoimmune condition  that needed treatment in the last 2 years apart from certain ones. Your doctor will know about this. 
• scarring on the lungs or active inflammation of the lungs (pneumonitis)  that needed treatment 
• inflammation of the pancreas
• a serious problem with how your muscles work 
• a lot of protein in your urine 
• had surgery and you aren’t better 
• a problem with how your immune system  works 
• had treatment that damps down the immune system. This includes steroids within 1 week of starting trial treatment unless it was a low dose. 
• HIV, an active hepatitis B or hepatitis C infection, tuberculosis or any other severe infection that needs treatment 
• areas of fluid in the tummy, lungs or around the heart that needed draining in the last 2 weeks 
• had a transplant with someone else’s cells  or an organ transplant   in the past 
• any other medical problem or mental health condition that could affect you taking part 

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

• are sensitive to pembrolizumab, quavonlimab, favezelimab, vibostolimab, MK-4830 or anything they contain 
• 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.