"I am glad that taking part in a trial might help others on their own cancer journey.”
A trial looking at a new type of immunotherapy for cancer of the pancreas that can't be removed with surgery
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
If you have cancer of the pancreas that can’t be removed with surgery, you would usually have gemcitabine chemotherapy. Although pancreatic cancer is difficult to treat with chemotherapy, it may help to shrink the cancer and control any symptoms you may have, hopefully improving your
Doctors are working to improve the treatment for pancreatic cancer. Researchers in this trial are looking at a new drug called IMM-101 which is a type of immunotherapy. It works by influencing the immune system in a way that should help it kill cancer cells. It may also help the chemotherapy to work better. IMM-101 is made from heat treated bacteria that is harmless to humans called mycobacterium obuense. The researchers will give IMM-101 to a group of people with advanced pancreatic cancer who are also having gemcitabine chemotherapy. They will compare the results with a second (control) group having gemcitabine alone.
The main aim of this trial is to compare the safety and effects of gemcitabine chemotherapy and IMM-101 with gemcitabine alone.
Who can enter
You may be able to enter this trial if
- You have a type of pancreatic cancer that started in the cells lining the
ductsof the pancreas called ductal adenocarcinoma of the pancreas
- You cancer was confirmed by removing a sample of cells from your pancreas (a biopsy)
- Your cancer cannot be removed with surgery
- The cancer has spread to another part of your body (apart from your bones, or in fluid in your abdomen or lungs) that has not yet been treated with radiotherapy, and doctors can measure this on a scan
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood tests
- You are willing to use reliable contraception if there is any chance that you or your partner could become pregnant (if you are using hormonal contraceptives, you must have been using these for at least 3 months)
- You are at least 18 years old
You cannot enter this trial if you have any of the following types of cancer affecting the pancreas
- Cancer of the cells in the pancreas that produce digestive juices (acinar cell carcinoma)
- Lymphoma of the pancreas
- A rare type of cancer called a neuroendocrine tumour of the pancreas
- A type of pancreatic cancer that developed from
You also cannot enter if you
- Have had chemotherapy for pancreatic cancer
- Have cancer that could be removed with surgery, but you either didn’t want surgery, or are not well enough to have it
- Have cancer that has spread to your brain or spinal cord (your central nervous system or CNS)
- Have had radiotherapy in the last 6 weeks
- Have ever had IMM-101 or a similar treatment before – you can check this with your doctor
- Have had any other trial treatment in the last 3 months
- Have had a slow release steroid injection in the last 6 weeks
- Have been taking a long course (for more than 2 weeks) of corticosteroids or another drug that suppresses the immune system, and you are still taking these or you took the last dose less than 2 weeks ago – please note, you must not stop medication before talking to your doctor
- Have a severe infection needing treatment
- Have HIV, hepatitis B, hepatitis C or syphilis
- Have a heart or blood pressure condition that is a cause for concern
- Have ever had a serious reaction to a drug
- Are pregnant or breastfeeding
- Have any other condition that might make you unwell if you took part, or affect the results of the trial – you can check this with your doctor
This trial will recruit 80 people. It is randomised. The people taking part will be put into one of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in. 53 people will join group 1 and 27 people will join group 2.
If you are in group 1, you will have gemcitabine chemotherapy and IMM-101. If you are in group 2 you will have gemcitabine on its own.
Both groups will have gemcitabine chemotherapy over 30 minutes, through a drip into a vein. You have gemcitabine once a week for 3 weeks, and then have a week off. This 4 week period is called a cycle of treatment. You have up to 12 cycles of gemcitabine.
If you are in group 1, you will also have a course of IMM-101 injections, into your upper arm. You stay in the clinic for at least 2 hours after your injection each time, so that a nurse can monitor your blood pressure, pulse and temperature.
The trial team will ask you to fill out 2 questionnaires before the trial, and at regular points during the trial. The questionnaires ask about any side effects you have had and how you have been feeling. These are called quality of life studies. You also complete a questionnaire about any pain you have had.
Once you have completed the whole course of gemcitabine chemotherapy, the team will ask everyone if they would like to join a follow up trial, where everyone will have IMM-101 injections.
Before you start the trial, you see the doctor and have some tests. These tests include
- Physical examination, including checking for a scar from your childhood TB vaccination (BCG)
- CT scan
- Heart trace (ECG)
- Blood and urine test
Once you start treatment, you visit the hospital once a week for 3 out of 4 weeks in each cycle of treatment. You will have up to 12 cycles of gemcitabine.
If you are in group 1, you also have the IMM-101 injection. You start the course of injections about 2 weeks before you start chemotherapy, and then have an injection
- Every 2 weeks for the next 2 doses, followed by a 4 week break
- Every 2 weeks for the next 3 doses
- Once every 4 weeks after this, for as long as your trial doctor thinks it is helping you
Your injections should be on a day when you are at the hospital for chemotherapy.
When you visit the hospital for treatment you may also repeat some of the tests you had before the trial at these appointments.
IMM-101 is very new and only a very small number of people have had it, as part of a clinical trial. So there may be side effects we don’t know about yet. Side effects we know about include
- Redness, swelling and discomfort around the injection site
- Joint pain
- Feeling sick
- Flu like symptoms
Common side effects of gemcitabine include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Hair loss
- Short term changes to the way your liver works
- Skin rash
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.
Professor Angus Dalgleish
Experimental Cancer Medicine Centre (ECMC)
Immodulon Therapeutics Ltd