A trial looking at gemcitabine, pembrolizumab and IMM-101 for pancreatic cancer (PRIMUS-006)

Cancer type:

Pancreatic cancer
Secondary cancers

Status:

Open

Phase:

Phase 2

This trial is looking at treating pancreatic cancer that has spread to another part of the body with gemcitabine, pembrolizumab and IMM-101. 

It is open to people who have: 

Cancer Research UK supports this trial.

More about this trial

Gemcitabine is a standard chemotherapy Open a glossary item drug that doctors use to treat pancreatic cancer. 

Pembrolizumab and IMM-101 are immunotherapy drugs. They work by helping the immune system Open a glossary item find and kill cancer cells. 

Doctors are trying to improve treatment for pancreatic cancer that has spread to another part of the body. We know from research that gemcitabine in combination with an immunotherapy might work better than gemcitabine by itself. 

In this trial, everyone will have gemcitabine, pembrolizumab and IMM-101.

The aims of the trial are to find out:

  • how well the combination of gemcitabine, pembrolizumab and IMM-101 works for pancreatic cancer that has spread
  • more about the side effects of this treatment combination

Who can enter

The following bullet points are a summary of 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 pancreatic cancer that is an adenocarcinoma type and has spread to another part of the body 
  • are a part of the Precision-Panc study and your tissue is suitable for gene Open a glossary item analysis. Your doctor will know about this. 
  • can look after yourself but might not be able to do heavy physical work (performance status 1)
  • have satisfactory blood test results
  • have an area of cancer the doctor can measure on a scan
  • are willing to use reliable contraception during treatment and for a time after 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 already had treatment that reaches the whole body (systemic treatment) for pancreatic cancer that has spread. This includes chemotherapy, a targeted cancer drug Open a glossary item or an immunotherapy. You might be able to join if you have had systemic treatment before, around the time of or after surgery to remove your cancer. This is as long as the aim was to cure the cancer and the treatment was completed more than 6 months before the cancer came back. 
  • have had a cancer treatment within 28 days of starting trial treatment 
  • have radiotherapy Open a glossary item within 2 weeks of starting trial treatment, for radiotherapy to relieve symptoms it is 1 week unless it was to the brain and spinal cord. Or you have had radiotherapy and have ongoing side effects. 
  • are in another clinical trial unless it does not include any treatment (an observational trial), or you have finished the treatment and are in follow up
  • have had another cancer in the past 3 years. This is apart from successfully treated non melanoma skin cancer Open a glossary item, carcinoma in situ Open a glossary item of the cervix, ductal carcinoma in situ (DCIS) Open a glossary item of the breast or prostate cancer that is only in the prostate.
  • have already had IMM-101 or another checkpoint inhibitor Open a glossary item. Your doctor will know this.

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

  • have, or had a heart problem Open a glossary item such as heart failure, unstable chest pain (unstable angina) or a heart attack in the past year 
  • have had a stroke Open a glossary item in the past year
  • have had major surgery within 28 days of starting trial treatment or you aren’t completely better after surgery
  • take medication that damps down the immune system Open a glossary item. This includes steroids Open a glossary item within 2 weeks of starting trial treatments unless it was a low dose. 
  • have a problem with how your kidneys work
  • have had a stem cell or bone marrow transplant from a donor (allogeneic transplant Open a glossary item) or had an organ transplant Open a glossary item
  • have had a severe or life threatening skin reaction after having an immunotherapy that stimulates the immune system. Ask your doctor about this. 
  • have an active autoimmune disease Open a glossary item or have had a severe autoimmune or inflammatory disease. This is apart from certain ones. Ask your doctor about this they will know more about it. 
  • have active hepatitis B, hepatitis C or another active infection that needs treatment that reaches the whole body 
  • have, or had, inflammation of the lungs that was not caused by an infection and it needed treatment with steroids
  • have any other medical conditions or mental health problems that could affect you taking part

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

  • are allergic or sensitive to any of the treatments used in this trial or any of their ingredients. This includes being allergic or sensitive to any medication that was made using mycobacteria. Your doctor will know about this.
  • have a live vaccine Open a glossary item within 30 days of starting the trial treatment. You cannot have a live vaccine during the study and within 30 days of stopping the trial treatment. The COVID-19 and seasonal flu vaccines are not live vaccines.
  • are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The team need 50 people to take part.

Everyone has:

  • gemcitabine
  • pembrolizumab
  • IMM-101

You have gemcitabine and pembrolizumab as a drip into a vein. You have IMM-101 as an injection just under the skin (an intradermal injection). 

You have treatment every 3 weeks. Each 3 week period is a cycle of treatment Open a glossary item. The first 2 cycles of treatment are slightly different to the rest of the cycles.

First cycle of treatment
You have IMM-101 between 7 and 2 days before the start of the cycle. You then have pembrolizumab and gemcitabine on the first day of the cycle. On day 8 at the start of the 2nd week you have gemcitabine and IMM-101. You have no treatment during the 3rd week. This is a rest week. 

Second cycle of treatment
On the first day of the cycle, you have pembrolizumab, gemcitabine and IMM-101. On day 8 at the start of the 2nd week you have gemcitabine. Then you have a rest week.

Third cycle of treatment and onwards
On the first day of the cycle, you have pembrolizumab and gemcitabine. On day 8 at the start of the 2nd week you have gemcitabine and IMM-101. Then you have a rest week. 

You can continue to have treatment with:

  • gemcitabine for a year
  • pembrolizumab and IMM-101 for 2 years

This is as long as it is helping and the side effects aren’t too bad. 

Hospital visits

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

You see the doctor regularly during treatment. This is to see how you are and for blood tests.

You have a scan every 6 weeks for a year and then every 12 weeks. This is until your cancer starts to grow again or spreads.

You see the doctor about a month after finishing treatment. This is to see how you are and for blood tests. You then see the doctor, or get a call from the trial team, every 12 weeks until your cancer starts to grow again or spread. 

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

Pembrolizumab can affect the immune system Open a glossary item. This may cause inflammation Open a glossary item and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects. 

These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.
 
If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

 

The most common side effects of pembrolizumab when given in combination with chemotherapy include:

Only a small number of people have had IMM-101. So, there may be some side effects we don’t know about yet. The most common side effects of IMM-101 we know about so far are:

  • high temperature (mild fever)
  • mild to moderate reactions at the injection site such as redness and swelling

We have more information about:

Your doctor will tell you about the possible side effects of the treatments used in the trial and answer any questions you may have. 

Location

Glasgow

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.

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

Chief Investigator

Professor David Chang
Professor Jeff Evans

Supported by

Cancer Research UK
Immodulon Therapeutics Limited
Merck, Sharp & Dohme
NHS Greater Glasgow and Clyde, University of Glasgow

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19123

Print page
Questions to ask your doctor about clinical trials
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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