A trial of nivolumab for advanced bowel cancer (ANICCA-CLASS II)

Cancer type:

Bowel (colorectal) cancer
Colon cancer
Rectal cancer
Secondary cancers

Status:

Open

Phase:

Phase 2

This trial is looking at how well nivolumab works for bowel cancer that has spread into the tissue around the bowel or spread elsewhere in the body. This is locally advanced or advanced bowel cancer.

It is for people who have a certain type of bowel cancer called microsatellite stable.

More about this trial

Your doctors might look to see if your bowel cancer cells have changes (mutations Open a glossary item) in certain genes. A small number of bowel cancers have gene changes called microsatellite instability (MSI). Most bowel cancers do not have these changes and are called microsatellite stable (MSS). 
 
We know from research that immunotherapy doesn’t work very well for people with microsatellite stable bowel cancer. But researchers have developed a new test to look at bowel cancer cells. They now think that immunotherapy might work for certain types of MSS bowel cancer. 
 
The test looks at the level of a protein called class 2. These proteins make the cancer more visible to the immune system Open a glossary item. Doctors think that a drug called nivolumab might work for people with high levels of this protein. 
 
Nivolumab is an immunotherapy. It helps the immune system to find and kill cancer cells. 
 
The aims of the trial are to:
  • find out how well nivolumab works for people with MSS bowel cancer that has a high level of the class 2 protein
  • see if it works well enough to routinely test people for this protein 

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 bowel cancer that has spread into surrounding tissues or elsewhere in the body (advanced cancer).
  • You have high levels of the class 2 protein in your bowel cancer cells.
  • There is no other suitable standard treatment Open a glossary item available.
  • You have cancer that can be measured on a scan.
  • You have satisfactory blood test results.  
  • You are well enough to be up and about for at least half the day (performance status 0,1 or 2).
  • You are willing to use reliable contraception during treatment and for up to 7 months after the final dose of nivolumab, if there is any chance you or your partner could become pregnant. 
  • You are at least 18 years old. 
Who can’t take part
 
You cannot join this trial any of these apply. 
 
Cancer related
You:
  • have cancer that has spread to the brain or the tissues (membranes) surrounding your brain (leptomeningeal disease)
  • have had chemotherapy, radiotherapy or a targeted drug Open a glossary item within 4 weeks of starting nivolumab
  • have had immunotherapy in the past 
  • have had another cancer unless it has been successfully treated with no sign of it for at least 3 years
  • have side effects from past treatments that aren’t getting better unless they are mild
Medical conditions
You:
  • are having treatment that affects the immune system within 7 days of starting nivolumab or your immune system doesn’t work very well
  • are at risk of developing a blockage in the bowel, for example, you have diverticulitis
  • have had an autoimmune disease Open a glossary item that needed treatment in the past 2 years, unless it was treatment to replace something that the body makes such as thyroxine or insulin
  • have had a severe allergic reaction to a monoclonal antibody drug Open a glossary item in the past
  • have a lung condition called pneumonitis
  • have HIV
  • have an active hepatitis B or hepatitis C infection 
  • have had tuberculosis (TB) 
  • have an active infection that needs treatment 
  • have any other medical condition or mental health problem that the trial team think would affect you taking part
 
Other
You:
  • have had a live vaccination Open a glossary item in the month before starting treatment 
  • have problems with drugs or alcohol
  • are pregnant or breastfeeding

Trial design

This is a phase 2 trial. Your doctor will test the cancer cells before you can take part. You can only have nivolumab if you have bowel cancer that:
  • is microsatellite stable 
  • has a high level of the class 2 protein
They think that about 1 in 10 people tested will have a high level of the protein. So, they plan to test about 360 people to find 36 people to start treatment.
 
Everyone has nivolumab. You have it every 2 weeks as a drip into a vein. It takes 30 minutes each time. 
 
You have treatment for as long as it is working and the side effects aren’t too bad. You can have it for up to 24 months.
 
Samples for research
You give some extra blood samples during treatment. You give the samples at specific times and the trial team will give you more information about this. They plan to use the samples to:
  • look for biomarkers Open a glossary item to predict who will benefit from treatment
  • see how well nivolumab is working.

Hospital visits

You see a doctor and have some tests before you can take part. These include:
  • physical examination
  • blood tests
  • CT scan 
You see the trial doctor every 2 weeks for a check up and blood tests. 
 
You have a CT scan while you are having treatment every:
  • 2 months for a year
  • 3 months after that if treatment is still working
This continues for as long as your cancer stays the same and does not get worse. If your cancer gets worse you stop having nivolumab. Your doctor can talk to you about other treatment options. 
 
If you stop having treatment because the side effects are too bad, you will continue to have a CT scan. This continues for as long your cancer doesn’t get worse.
 
Follow up – after you stop having nivolumab
You see the trial team a month after you finish treatment for a check up. 
 
After that, you go to hospital for a check up:
  • once a month for 6 months
  • every 3 months for up to 18 months

Side effects

You are monitored closely for side effects when having treatment as part of the trial. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 
 
Nivolumab can affect the immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.
 
The most common side effects of nivolumab include:
We have more information about the side effects of nivolumab
 

Location

London

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 Gary Middleton

Supported by

University of Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16343

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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