A trial of chemoradiotherapy with or without pembrolizumab for cervical cancer (KEYNOTE-A18)

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 cervical cancer that is at least 2cm, has grown into the vagina or the surrounding tissue (stage 1B2 to 2B). And has spread to the lymph nodes . Or if you have either lymph node spread or bowel spread or bladder spread (stage 3 to 4A).
• have squamous cell cancer, adenocarcinoma or adenosquamous carcinoma type of cervical cancer   
• have an area of cancer that the doctor can see on a scan
• have a tissue sample (biopsy ) that the trial team can ask for. If not you must be willing to have a fresh biopsy taken. 
• can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results
• and your partner are willing to use reliable contraception during treatment and for a time after if there is any chance you might get 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 that has spread to organs far away from the cervix such as the lungs (stage 4B) 
• are having your womb removed (hysterectomy) or part of it as of your cancer treatment. You might be able to join if you have had a previous hysterectomy that was not part of your cancer treatment.
• can't have internal radiotherapy (brachytherapy)
• have had previous immunotherapy  treatment
• have had previous cancer treatment that reaches your whole body such as chemotherapy within 4 weeks of being put into a trial treatment group (randomisation )
• have had an experimental drug as part of another clinical trial within 4 weeks of randomisation
• have had another cancer that has got worse or needed treatment in the past 3 years. This is apart from successfully treated non melanoma skin cancer  and any in situ carcinoma.  

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

• have a kidney problem where both kidneys are swollen because of too much urine in them. You might be able to join if you have had one of your kidneys treated for this such as by putting in a tube to help drain the urine. 
• have had drugs that stimulate the immune system within 6 weeks of starting treatment
• can’t have the chemotherapy drug cisplatin
• have an immune system  that isn’t working very well 
• are taking steroids within a week of starting treatment. Unless it is a small dose. Your doctor will know what the dose is.
• are taking any other medication that affects how well the immune system works within a week of starting treatment
• have an autoimmune disease  that has needed treatment in the past 2 years. This is apart from creams, inhalers or medication to replace a substance the body usually makes. 
• have inflammation of the lungs or had inflammation of the lungs that needed treatment with steroids
• have an active infection that needs treatment
• have HIV, hepatitis B or hepatitis C
• have had a stem cell transplant from someone else (allogeneic transplant)
• have had an organ transplant
• have any other medical condition or mental health problem that the doctor or the trial team think could affect you taking part

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

• are allergic or sensitive to pembrolizumab or any of its ingredients
• have a live vaccine  within 30 days of starting treatment in the trial
• are pregnant or breastfeeding