A trial looking at durvalumab for rectal cancer (PRIME RT)

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
There are 2 parts to this trial. The safety run in part and the main part. 

Safety run in part (closed to recruitment)
You may be able to join the safety run in part of the trial if you:

• have adenocarcinoma of the back passage (rectum)
• are having chemotherapy or radiotherapy but not surgery  

Main trial
You may be able to join the main part of the trial if all of the following apply. You:

• have adenocarcinoma of the back passage (rectum) 
• have a cancer that has grown into the surrounding tissue
• can have treatment with the aim to cure the cancer

For both parts all of the following must apply. You:

• have had a CT scan
• an MRI scan  that shows your cancer is high risk. Your doctor can tell you if your cancer is high risk. 
• are active but might not be able to do heavy physical work (performance status 0 or 1)
• can have radiotherapy 
• have satisfactory blood test results
• are willing to use contraception during the trial and for a period of time after if 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 that has spread. This does not apply to people in the safety run in part.  
• have had previous radiotherapy to the area between the hips (pelvis)
• have had an immunotherapy treatment 
• have had another cancer or chemotherapy for another cancer in the past 5 years. This is apart from successfully treated non melanoma skin cancer , early cancer  of the cervix or a prostate cancer that has not spread out of the prostate.

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

• can’t have an MRI scan 
• weigh 30 kgs (4½ stone) or less
• have major surgery within 28 days of joining the trial
• have had chest pain (angina) or a heart attack in the past 6 months or any other heart problem
• have had a major blood clot such as in the lungs within the past 6 months unless you are on a stable dose of medication for it such as warfarin
• have an inflammation of the bowel that needs ongoing treatment
• have an autoimmune disease  that needed treatment in the past 2 years. This is unless it was medication to replace a substance in the body.
• have a low resistance to infection (immune deficiency)
• are taking medication that affects your immune system. This doesn’t include a small dose of steroids, inhalers, creams or local steroid injections.
• have had disease affecting the air sacs of the lung 
• have inflammation of the lungs or have had inflammation of the lungs that needed treatment
• having certain treatments – your doctor will know which treatments these are
• have severe diarrhoea
• have taken an experimental drug as part of another clinical trial. This is if you have had it within 28 days of starting the trial treatment.
• can’t swallow tablets or you have a problem with your digestive system  that affects how well your body absorbs tablets
• have HIV, hepatitis B or hepatitis C
• have had tuberculosis (TB)
• have any other medical condition or mental health problem that the doctor or the trial team thinks can affect you taking part

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

• have had a live vaccine  within 30 days of starting the trial treatment. COVID-19 vaccines are allowed.
• are allergic to any of the treatments used in the trial or any of their ingredients
• are pregnant or breastfeeding

For the Safety run in part only
You can’t join the trial if you have ongoing moderate to severe side effects from previous treatments. This doesn’t include hair loss, loss of skin colour (vitiligo) or certain blood test results. Your doctor will know about these.