A trial comparing usual treatment with pembrolizumab for bowel cancer that has spread (KEYNOTE 177)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is open to people with certain gene changes (mutations) in the bowel cancer genes. These gene changes are microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR).
More about this trial
Chemotherapy is the usual treatment for bowel (colorectal) cancer that has spread to another part of the body (advanced cancer). You might have this alongside a 
therapy drug such as bevacizumab or cetuximab.
Pembrolizumab (also known as MK-3475) is a type of . It helps the to recognise and attack cancer cells.
Researchers think it might work better than usual treatment for people with the gene changes () microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR). But they aren’t sure, so they want to find out more. Your doctor will test for the gene changes before you can take part.
In this trial, some people have and some have pembrolizumab.
The aims of this trial are to
- compare usual treatment with pembrolizumab to see which works best
- learn more about the side effects
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.
You might be able to join this trial if all of the following apply. You
- Have bowel (colorectal) cancer that has spread to another part of the body
- Have microsatellite instability high (MSI-H) or mismatch repair deficiency in the bowel cancer genes
- Have cancer that can be seen on a scan
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
- Have satisfactory blood test results
- Are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any chance that you or your partner could become pregnant
- 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 and is causing symptoms. You might be able to take part if you have had treatment and the cancer isn’t causing any symptoms, it has not got any worse or you haven’t taken
steroids in the last 28 days - Have inflammation of the covering of the brain (carcinomatous meningitis)
- Have already had treatment that reaches the whole body (systemic treatment) for advanced bowel cancer. You might still be able to take part if you had chemotherapy after surgery and it finished more than 6 months ago.
- Have had radiotherapy in the last 4 weeks and haven’t recovered from side effects. You might be able to take part if you had radiotherapy to areas of cancer spread to help with symptoms and have recovered from short term side effects
- Have had previous treatment with any anti-PD1, anti-PDL1, anti-PD2 or anti-CTLA-4 drugs such as ipilimumab, nivolumab or any similar drugs
- Are having or have had treatment or used an experimental device as part of a clinical trial within 4 weeks of joining this trial
- Are sensitive to any of the drugs used in the trial or there is any other reason you might not be able to have them
- Have another cancer that is getting worse or needs treatment apart from
non melanoma skin cancer or very early cancer of the cervix (CIS) that has been successfully treated - Have an
autoimmune disease such as rheumatoid arthritis or multiple sclerosis and you have had treatment in the last 2 years. If you have had treatment to replace hormones in the body, you might still be able to take part. - Have problems with your
immune system or have taken drugs that suppress your immune system in the last 7 days - Have a inflammation of the lung called pneumonitis or interstitial lung disease
- Have had major surgery, a biopsy or a traumatic injury in the last 28 days
- Have had a
live vaccine in the last 30 days - Have an infection that needs treatment as a drip into a vein
- Are known to have HIV
- Have or have had hepatitis B or hepatitis C
- Have a significant problem with drugs or alcohol
- Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- Are pregnant or breastfeeding
Trial design
This is an international phase 3 trial. Researchers need 270 people to take part including at least 4 from the UK.
It is a randomised trial. You are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- One group have pembrolizumab
- The other group have 1 of the following usual treatments
o FOLFOX
o FOLFORI
o FOLFOX and bevacizumab
o FOLFOX and cetuximab
o FOLFIRI and bevacizumab
o FOLFIRI and cetuximab
Usual treatment
If you are having usual treatment, your doctor will explain which drugs they think are best for you. They will also explain how often you have them. You have treatment for as long as it is helping you and the side effects aren’t too bad.
If your cancer gets worse, you stop treatment. You might be able to start having pembrolizumab. Your doctor can tell you more if this applies.
Pembrolizumab
You have pembrolizumab through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. You have it for up to 2 years as long as it is helping you and you don’t have any severe side effects.
After having pembrolizumab for 2 years, if your cancer then starts to get worse you might be able to have it again. Your doctor can tell you more if this applies.
Tissue samples
Before starting treatment, the research team might ask you to have a of your cancer. Or they might be able to use an older sample.
The sample is used to confirm the gene changes being looked at in this trial
They will ask if any samples left over can be used for research purposes. You don’t need to agree to this, if you don’t want to. You can still take part in the trial.
Blood samples
You have some extra blood tests as part of this trial. The researchers want to find out what happens to pembrolizumab in the body.
The doctors will ask to look at substances called that can help them see how a treatment is working. Where possible you have the blood samples at the same time as your routine blood tests. You don’t have to agree to this research if you don’t want to. You can still take part in the trial.
Hospital visits
You see the doctor and have some tests before you start treatment. The tests include
You go to hospital to have treatment. You probably won’t need to stay overnight.
You see the doctors regularly for a check up and blood tests
- once every 3 weeks if you are have pembrolizumab
- about twice a month if you are have usual treatment
You see the trial team a month after you finish treatment. They will repeat some of the tests you had when you joined the trial. You have an MRI or CT scan and see the trial team every 9 weeks for a check up.
You see the doctors until either your cancer gets worse or you start another anti cancer treatment.
Side effects
The most common side effects of pembrolizumab are
- itchy skin and skin rash
- tiredness (fatigue)
- loss of appetite
- shortness of breath
- cough
- joint pain
- swelling of the legs or feet
- weakness
- back pain
- low salt levels in the blood
- pain in your tummy (stomach)
- feeling or being sick
- diarrhoea or constipation
- a drop in red blood cells (anaemia)
We have information about the side effects of
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.
Chief Investigator
Dr Kai-Keen Shiu
Supported by
Merck Sharpe & Dohme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
