A trial of defactinib and pembrolizumab for people with solid tumours (FAK-PD1)

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 at least 1 area of cancer that can be seen and measured on a scan and that has got worse after the last cancer treatment  
• Have had all suitable treatments (standard treatment) for your cancer or your doctor thinks pembrolizumab is a suitable treatment
• Have a tissue sample of your cancer available that was taken either when you were diagnosed or during treatments (archival tissue sample) 
• Are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) and this hasn’t change in the past 2 weeks
• Have satisfactory blood tests results
• Are able to swallow and absorb tablets   
• Are at least 18 years old
• Are willing to use reliable contraception during treatment and for 4 months afterwards if there is any possibility you or your partner could become pregnant

You may be able to join the 1st part of the trial if you have a solid tumour (not a leukaemia, myeloma or lymphoma) that has spread or continued to grow despite treatments.

You may be able to join the 2nd part of the trial if 1 of the following also apply. You:

• Have adenocarcinoma of the pancreas
• Have non small cell lung cancer (NSCLC) and you are happy to have new samples of tissue taken
• Have mesothelioma that started in the sheets of tissue that cover the lungs (pleural mesothelioma) or in the tissue lining the inside of the tummy (peritoneal mesothelioma), and you are happy to have new samples of tissue taken

You cannot join this trial if any of these apply:

Cancer related

• Your cancer has spread to your brain unless you have had treatment, it hasn’t got worse in the past 4 weeks and you are no longer taking steroids
• You have had cancer treatment that reached your whole body (systemic) in the last month (6 weeks if you had the drug mitomycin C or chemotherapy from a group of drugs called nitrosoureas)    
• You have moderate or severe side effects from previous treatment apart from hair loss
• You have had another cancer in the past 5 years apart from successfully treated early cancer (such as carcinoma in situ of the cervix or non-melanoma skin cancer, or prostate cancer that has been stable for more than a year)

Medical conditions

• You have taken part in another clinical trial in the past 4 weeks  
• You are sensitive to defactinib, pembrolizumab or anything they contain
• You have heart problems such as high blood pressure (hypertension) that isn’t controlled or you have had a heart attack
• You have taken drugs that damp down your immune system such as steroids in the past 2 weeks, unless it was a very small amount or it was to replace something that the body makes such as cortisol   
• You have or have had an autoimmune disease that needed systemic treatment in the past 2 years, apart from treatment to replace something the body makes
• You have lung problems such as interstitial lung disease or inflammation of the lung (pneumonitis)
• You have a serious infection that isn’t controlled by medication
• You have tuberculosis 
• You have HIV
• You have hepatitis B or hepatitis C
• You have had a live vaccine in the last month
• You have any other serious medical condition that the trial team think could affect you taking part

Other

• You are pregnant or breastfeeding