"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of nivolumab for advanced bowel cancer (ANICCA-CLASS II)
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
- 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
- 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
- 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.
- have cancer that has spread to the brain or the tissues (membranes) surrounding your brain (leptomeningeal disease)
- have had chemotherapy, radiotherapy or a
targeted drugwithin 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
- 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 diseasethat 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 drugin 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
- have had a live
vaccinationin the month before starting treatment
- have problems with drugs or alcohol
- are pregnant or breastfeeding
- is microsatellite stable
- has a high level of the class 2 protein
- look for
biomarkersto predict who will benefit from treatment
- see how well nivolumab is working.
- physical examination
- blood tests
- CT scan
- 2 months for a year
- 3 months after that if treatment is still working
- once a month for 6 months
- every 3 months for up to 18 months
- a drop in the number of blood cells causing an increased risk of infection, breathlessness, bruising and bleeding
- feeling sick
- skin rash or itchy skin
- high levels of sugar in the blood
- inflammation of the kidneys or liver
- inflammation of the lung tissue causing symptoms such as shortness of breath or cough (pneumonitis)
How to join a clinical trial
Professor Gary Middleton
University of Birmingham