A trial looking at MGN1703 for bowel cancer that has spread (IMPALA)

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

Cancer type:

Bowel (colorectal) cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at a new drug called MGN1703 for bowel cancer that has spread to another part of the body. It is for people whose cancer can’t be removed with surgery.

More about this trial

If bowel cancer has spread to another part of the body and can’t be removed with an operation, doctors can treat it with chemotherapy. This can slow down or stop the cancer growing and control symptoms, but doctors are looking for new treatments to help this group of people.

In this trial, researchers are looking at a drug called MGN1703 to see if it can help people with bowel cancer that has spread.

MGN1703 is a type of biological therapy called immunotherapy.  It uses the immune system to help kill cancer cells

The aims of the trial are to find out

  • How safe MGN1703 is
  • If MGN1703 can increase the length of time people live and stop bowel cancer spreading further
  • More about the side effects and whether it improves quality of life

Who can enter

You may be able to join this trial if all of the following apply.

  • You have cancer that started in the large bowel (colon) or back passage (rectum), has spread to another part of the body and can’t be removed with an operation
  • You have recently had between 12 and 30 weeks of chemotherapy for cancer that has spread (you may have also had biological therapy alongside chemotherapy) and a scan shows that your cancer has shrunk or there is no sign of it after treatment (your doctor can confirm this)
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
  • You have satisfactory blood test results
  • You are at least 18 years old

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

  • Have cancer that has spread to your brain
  • Have had immunotherapy or medication to suppress your immune system Open a glossary item in the last 6 weeks or continuous steroid treatment in the last 2 weeks
  • Can’t have MGN1703 for some reason (your doctor can advise you about this)
  • Have had a stem cell transplant Open a glossary item using stem cells from someone else or an organ transplant in the past
  • Have had antibiotics in the last 2 weeks
  • You have a low number of red blood cells in your body (anaemia Open a glossary item) and need to have regular blood transfusions
  • Have an autoimmune disease Open a glossary item or a similar disease (the trial team can advise you)
  • Have a bad infection or you are having high temperatures (fevers)
  • Have a lung condition called interstitial lung disease
  • Have had any other cancer in the last 5 years apart from basal cell skin cancer or very early stage cervical cancer that was successfully treated (the trial team can advise you more about this)
  • Have had  an experimental treatment as part of a clinical trial in the last year
  •  Have had a vaccination in the last month
  • Have an active hepatitis B or hepatitis C infection
  • Are HIV positive
  • Have any other medical condition  or mental health problem that the trial team think would affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The researchers need 540 people to join.

It is a randomised trial. You are put into 1 of 2 groups by a computer. Neither you nor your doctor can decide which group you are in.

The trial is in 2 parts. The 1st part is to see if MGN1703 can stop the cancer from spreading further. This is called maintenance treatment. The 2nd part is for people whose cancer does get worse .This is called re-induction treatment.

In the 1st part,

  • People in one group have MGN1703 alone
  • People in the other group have standard treatment. Doctors call this the control group

If you are in the MGN1703 group, you have it as an injection under the skin. If you are in the control group, you have treatment that your doctor thinks is the most appropriate for you. This may include chemotherapy with or without biological therapy, or a period without any treatment.

Everyone will have scans about every 6 to 8 weeks depending on which hospital you are having your treatment at. If the scan shows that your cancer is getting worse, you will join the 2nd part of the trial. If your cancer doesn’t get worse you continue with the treatment you are having.

If you join part 2,

  • People in the MGN1703 group have chemotherapy alongside the MGN1703 injections
  • People in the control group have chemotherapy. The type you have depends on your individual situation and the doctor can tell you more about this.

If you are having MGN1703, you have it twice a week in the 1st part of the trial. How often you have it in the 2nd part depends on the chemotherapy you have. The trial team can tell you more about this.

You will continue to have regular scans. If the scan shows that your cancer is getting worse in the 2nd part, you will stop taking part in the trial. Your doctor will then discuss further treatment options with you.

Hospital visits

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

  • Physical examination
  • CT scan or MRI scan
  • A heart trace (ECG Open a glossary item)
  • Blood tests
  • Urine tests

If you are having MGN1703, you go to the hospital twice a week for your injection in the 1st part of the trial. You stay 30 minutes after the first 3 injections to check that you don’t have a reaction to it. In 2nd part of the trial, how often you have the MGN1703 injections depends on your chemotherapy.

You go to hospital to have chemotherapy. The number of visits will depend on the type of treatment you have.

Everyone will see the trial team once a month for the first 5 months and then every 2 months after that.

When you finish taking part in the trial, the trial team will repeat some of the tests you had when you joined. The trial team will follow you up to see how you are every 3 months. This could be at a routine check up at the hospital or a phone call at home.

Side effects

MGN1703 is a new drug so there may be some side effects that we don’t know about yet. So far, the side effects of MGN1703 have been mild to moderate. The most common include

  • A temperature (fever)
  • A skin reaction at the site of the injection such as itching, swelling, pain, redness and hardening of the skin

If you have chemotherapy, your doctor will talk to you about all the possible side effects of the treatment that they think is best for you. We have more information about the side effects of chemotherapy.

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

Professor David Cunningham

Supported by

Mologen  AG
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12766

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

Alan took part in a clinical trial for bowel cancer patients

A picture of ALan

“I think it’s essential that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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