A trial of pembrolizumab and rituximab for Waldenstrom's macroglobulinaemia (PembroWM)

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. 

Who can take part

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

• have had at least 1 type of treatment for Waldenstrom’s macroglobulinaemia (WM) 
• have WM that continued to grow during treatment or came back after treatment had finished
• have WM that can be measured 
• have satisfactory blood test results
• are up and about, can care for yourself but might not be able to work (performance status 0, 1 or 2)
• are willing to use reliable contraception during treatment. Women should continue to use it for a year after. Men should use it for 4 months after. This is 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 WM that has spread to the brain or spinal cord 
• have had rituximab and the WM got worse during treatment or within 6 months after finishing treatment
• have had another cancer treatment within 4 weeks of agreeing to join this trial apart from certain targeted drugs . These drugs are called BTK inhibitors such as ibrutinib. 
• have had another treatment that affects the T cells  such as Campath within 3 months of starting treatment
• have another cancer that is getting worse or needs treatment. This does not include successfully treated non melanoma skin cancer . And it doesn’t include in situ carcinoma  of the cervix.

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

• have had heart problems in the past 6 months. This includes a heart attack, angina that isn’t well controlled congestive cardiac failure or a heart rhythm that needs treatment.
• have had a stroke, mini stroke (TIA) or similar in the past 6 months
• have an infection that needs treatment
• have an autoimmune disease . This does not include type 1 diabetes or thyroid problems controlled by medication. Nor does it include skin problems such as vitiligo, psoriasis, hair loss (alopecia). It also doesn’t include a drop in platelets  thought to be caused by Waldenstrom’s macroglobulinaemia.
• had a condition where your red blood cells  breakdown (haemolytic anaemia)
• have inflammation of the lining of the bowel (colitis) that isn’t caused by an infection
• had inflammation of the lungs not caused by an infection that was treated with steroids or you have inflammation of the lungs (pneumonitis)
• have had an experimental drug within 4 weeks of starting treatment
• have hepatitis B or hepatitis C 
• have HIV
• have major surgery within 4 weeks of agreeing to join the trial
• have had a drug similar to pembrolizumab or rituximab
• have had a bone marrow transplant using someone else’s bone marrow (allogeneic transplant ) 
• have had an organ transplant  and are taking medication to damp down the immune system
• have an immune system  that isn’t working well
• are taking medication such as steroids that damps down the immune system. So you can’t have taken it within 7 days of starting treatment. This doesn’t include nasal sprays, inhalations, creams, steroid injections that affect only one area of the body.  And you can have taken a low dose of steroids, that is up to 10mg a day for 5 days of steroid tablets. 
• are having treatment that affects your whole body for an ongoing (chronic) infection
• have any other medical condition or mental health problem that the trial team or your doctor think could affect you taking part

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

• are allergic to pembrolizumab, rituximab, another drug like rituximab or any of their ingredients
• have a live vaccine  or live attenuated vaccine within 30 days of starting treatment
• are pregnant or breastfeeding