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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Pancreatic cancer
Secondary cancers

Status:

Closed

Phase:

Phase 3

This trial is looking at a new drug called AM0010 for cancer of the pancreas that has spread (advanced pancreatic cancer).

It is open to people with advanced pancreatic cancer that continued to grow during or after having gemcitabine.

More about this trial

Doctors can treat advanced pancreatic cancer with a chemotherapy drug, such as gemcitabine, or a combination of chemotherapy drugs. One combination of chemotherapy drugs they might use is FOLFOX:

  • folinic acid 
  • fluorouracil
  • oxaliplatin

AM0010 is a type of immunotherapy. It works by stimulating your immune system Open a glossary item to find and kill cancer cells.

Early phase 1 trials Open a glossary item show that AM0010 in combination with FOLFOX might work well to treat pancreatic cancer that has spread. To find out if this is the case researchers need to do a larger phase 3 trial Open a glossary item.

In this phase 3 trial half the people will have AM0010 and FOLFOX. The other half will have FOLFOX on its own.

The main aim of the trial is to compare AM0010 and FOLFOX with FOLFOX alone to find out which is best to treat advanced pancreatic cancer.

Who can enter

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 Open a glossary item or MRI scan Open a glossary item, 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 Open a glossary item 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 Open a glossary item or a platinum drug Open a glossary item 
  • can’t have gemcitabine
  • are known to have dihydropyrimidine dehydrogenase deficiency (DPD)
  • have had another cancer apart from successfully treated non melanoma skin cancer Open a glossary item 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 Open a glossary item 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.

Trial design

This is an international phase 3 trial. The team need about 566 people worldwide to join the trial.

It is a randomised trial. Everyone taking part is put into 1 of 2 groups. Neither you nor your doctor can choose which group you are in.  The 2 groups are:

  • AM0010 and FOLFOX
  • FOLFOX

You have treatment every 2 weeks. Each 2 week period is called a cycle of treatment.

FOLFOX includes the drugs:

  • oxaliplatin
  • folinic acid
  • 5FU

You have all these as a drip into a vein. On the first day of each treatment cycle you have oxaliplatin followed by folinic acid and 5FU.

You then have 5FU as a continuous infusion over 2 days. You have it through a small pump. You carry the pump on a belt or in a small bag. You can go home with the pump. The nurses will tell you how to look after it.

You have up to 12 cycles of FOLFOX.

You have AM0010 as an injection into the skin (subcutaneous injection).

A member of the trial team will teach you or a relative how to give the injection of AM0010. They will watch you do the 1st injection to make sure you can do it. You then give the injections yourself at home.

You have it once a day for 5 days and then 2 days of no treatment. You continue having it the same in the 2nd week.

Each time you start a cycle of treatment the nurses will give you enough AM0010 injections to take home to last the 2 weeks.

If you are having AM0010 you have a diary to write down the date and time when you had it. You need to bring this with to every hospital appointment for the trial team and the doctor to see.

Blood and tissue samples

The trial team take some extra blood samples. They will use these to find out what happens to AM0010 in the body. They will also look for substances (biomarkers Open a glossary item) in the blood that might tell them how well the treatment is working.

They will also ask your permission to take a small piece of tissue from when you were first diagnosed.

Hospital visits

You see the doctor to have some tests before taking part in the trial. These tests include:

  • a physical examination
  • blood tests
  • heart trace (ECG Open a glossary item)
  • CT scan or MRI scan

During FOLFOX treatment you see the doctor every 2 weeks to see how you are and have blood tests.

If you are having AM0010 you will also have a heart trace done at the same time. You will also have another heart trace and bloods taken at the end of:

  • treatment cycle 1
  • treatment cycle 2
  • treatment cycle 4

You have a CT scan or MRI scan every 8 weeks.

After FOLFOX treatment you see the doctor for a physical examination and blood tests.

If you had FOLOFOX on its own your doctor will tell you how often they want to see you.

If you had AM0010 and are continuing to have it, you see the doctor every month for a physical examination and to have blood tests. You also have a CT scan or MRI scan every 8 weeks.

When you stop having AM0010 you see the doctor for:

  • a physical examination
  • blood test
  • heart trace

A member of the trial team will then phone to see how you are and if you have had any other treatment for your cancer:

  • every 2 months for a year
  • then every 3 months for up to 3 years

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:

  • you have severe side effects
  • your side effects aren’t getting any better
  • your side effects are getting worse
  • you notice anything unusual or anything that has changed

AM0010 is a new drug and there might be side effects we don’t know about yet.

The most common side effects of AM0010 are:

We have information about the side effects of FOLFOX.

Your doctor will talk to you about all the side effects of AM0010 and FOLFOX before you agree to take part in the trial.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Pippa Corrie

Supported by

ARMO BioSciences 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15405

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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