A trial looking at AM0010 for cancer of the pancreas (Sequoia)

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 adenocarcinoma of the pancreas that has spread
• have an area of cancer that can be measured
• have had treatment containing gemcitabine and your cancer continued to grow during treatment or after treatment
• have had a CT scan  or MRI scan , or your doctor has examined you and recorded, that your cancer has got worse during your first course of  treatment within 28 days of being randomised  in this trial
• can do everything apart from heavy physical work (performance status 0 or 1)
• must have finished any treatment at least 2 weeks ago
• have satisfactory blood test results
• are willing to use reliable contraception during the treatment and for a few months after if there is any chance you or your partner could become pregnant
• are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related

You:

• have cancer of the pancreatic islet, acinar cell cancer, a non adenocarcinoma such as lymphoma or sarcoma, adenocarcinoma that started in the biliary tree or cystic adenocarcinoma
• still have side effects from the gemcitabine unless they are mild
• have had radiotherapy or surgery to treat your pancreatic cancer
• have had any chemotherapy after having surgery to remove your cancer
• can’t do as much as you could before, within 2 days of being put into your treatment group (your performance status has got worse)
• have had AM0010 before
• have had chemotherapy containing a fluoropyrimidine drug  or a platinum drug  
• can’t have gemcitabine
• are known to have dihydropyrimidine dehydrogenase deficiency (DPD)
• have had another cancer apart from successfully treated non melanoma skin cancer  or another cancer that was treated and there has been no sign of it for at least 3 years
• have significant fluid on the abdomen (ascites) and you need to have the fluid drained 1 or more times every 2 weeks

Medical conditions

You:

• have had immunotherapy that blocks CTLA4, PD1 and PD-L1
• have a serious infection that isn’t controlled or you need antibiotic treatment through a drip into the vein (intravenous)
• have HIV
• have or had hepatitis A, hepatitis B or hepatitis C
• have had a significant bleeding episode, for example in your gut or in your head, within 2 weeks of being randomised
• are taking warfarin and are not willing or able to change to low molecular heparin or a similar medication
• have had major surgery within 28 days before being randomised or you are likely to need surgery during the trial period
• have an autoimmune disorder  that affects your nerves for example multiple sclerosis or Guillain-Barré
• have had a heart attack within the past 6 months or another heart condition such as congestive heart failure or unstable angina
• have any other medical or mental health condition that your doctor or the trial team think could affect you taking part

Other

You are pregnant or breastfeeding.