A trial of pembrolizumab with radiotherapy for people with advanced bladder cancer (PLUMMB)

The following bullet points list 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. 

You may be able to join this trial if all of the following apply. 

• You have invasive bladder cancer that has spread to the nearby tissues or to another part of the body (T2 to T4, N0 to N3 and M0 to M1)
• You have at least 1 area of cancer that can be seen on a scan or if you have bladder cancer that has grown through the bladder wall or has spread to the lymph nodes but no further on a cystoscopy
• You are not able to have treatment (such as an operation to remove the bladder or chemoradiotherapy) to cure your cancer for any reason  
• You are willing to have a sample of your cancer taken (a biopsy ) if there is no suitable sample available (an archival tissue sample) 
• You have satisfactory blood tests results
• You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) 
• You are at least 18 years old
• You are willing to use reliable contraception during the trial and for 4 months afterwards if there is any chance you or your partner could become pregnant 

You cannot join this trial if any of these apply.

Cancer related

• Your cancer has spread to your brain, tissues surrounding your brain or your spinal cord . You might still be able to take part if you have had treatment, it hasn’t got worse in the past 4 weeks and you haven’t taken steroids in the past 7 days
• You have had radiotherapy to the area between your hip bones (pelvis)
• You have had surgery, chemotherapy, radiotherapy or a targeted therapy (biological therapy) in the past 4 weeks and you still have moderate to severe side effects (apart from hair loss (alopecia) and mild changes to your nails or problems with your nerves (neuropathy)
• You have had the drug pembrolizumab or any other drug that affects a protein called PD-1 or certain immune cells called T-cells such as ipilimumab
• You have had another cancer apart from successfully treated early cancer (carcinoma in situ ) of the cervix or non-melanoma skin cancer

Medical conditions

• You have had an experimental drug or used an experimental device as part of another clinical trial in the past 4 weeks
• You have an infection that needs treatment that reaches your whole body (systemic treatment) 
• You have a weakened immune system or you have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 7 days
• You have or have had an autoimmune disease that needed systemic treatment in the past 3 months, apart from vitiligo, childhood asthma that has resolved, thyroid problems that are controlled by medications or you need drugs to make you breathe easier (bronchodilators) or steroid injections
• You have lung problems such as interstitial lung disease or inflammation of the lung (pneumonitis) 
• You have bowel problems such as inflammatory bowel disease or any other problem that your doctor thinks could affect you having radiotherapy to the pelvis
• You have hepatitis B or hepatitis C 
• You have HIV 
• You have any other serious medical condition or mental health problem that the trial team think could affect you taking part

Other

• You have had a live vaccination  in the past 30 days
• You take drugs or drink large amounts of alcohol
• You are pregnant or breastfeeding