
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at new immunotherapy drugs to treat bowel cancer that has spread elsewhere in the body. It is comparing these drugs with pembrolizumab on its own.
Bowel cancer that has spread to another part of the body is advanced cancer.
It is for people with certain gene changes in the bowel cancer cells. These gene changes are or
.
You might have pembrolizumab for advanced bowel cancer that hasn’t been treated and has the gene changes that means it is called:
Pembrolizumab is an immunotherapy. It helps the find and kill cancer cells.
Doctors are looking for ways to improve treatment for advanced bowel cancer. In this trial they are comparing pembrolizumab alone with 4 new immunotherapies. These are:
Doctors aren’t sure how well these treatments will work. So they are doing this trial to find out more.
The main aims of the trial are to:
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:
Who can’t take part
Cancer related
You cannot join this trial if any of the following apply. You:
Medical conditions
You cannot join this trial if any of the following apply. You have:
Other
You cannot join this trial if any of the following apply. You:
This phase 2 trial is taking place worldwide.
There are 2 parts to this trial. Part A is for people whose bowel cancer got worse on or after chemotherapy. Part A isn’t open in the UK.
Part B is for people who haven’t yet had treatment for advanced bowel cancer. This part is open in the UK.
The team need 320 people to take part. About 120 people join Part A and about 200 people join Part B. This includes 12 or more people from the UK who will join part B.
Treatment for advanced bowel cancer that hasn’t been treated yet (part B)
A computer puts you into a treatment group. Neither you nor your doctor can decide which group to join. There are 5 groups. You have 1 of the following:
How you have treatment
You have treatment as follows:
You have all your treatment as a drip into a vein.
Everyone has treatment for up to 2 years as long as it is working and the side effects aren’t too bad.
Quality of life
The trial team ask you to fill out a questionnaire:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Samples for research
The researchers might ask you to give a tissue sample ( if there isn’t one that they can access. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to:
You see the doctor and have tests before you can take part. These include:
You have treatment at the hospital as an outpatient. You see the trial doctor for regular check ups and blood tests.
You have a CT or MRI scan every 9 weeks. You stop the trial scans if your cancer gets worse.
Follow up
You see the trial team one month after you stop treatment. You continue to see them every 9 weeks if you stopped treatment but your cancer didn’t get worse.
The trial team call you every 3 months if you stopped treatment because your cancer got worse. This is to see how you are getting on.
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.
All the treatments in this trial can affect the 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. |
MK-1308A is a new drug so there may be side effects we don’t know about yet. The common side effects reported so far include:
MK-7684A is a new drug and there may be side effects we don’t know about yet. The common side effects reported so far include:
MK-4280A is a new drug and there may be side effects we don’t know about yet. The common side effects reported so far include:
MK-4830 and pembrolizumab is a new combination of treatment. The common side effects reported so far include:
We have more information about pembrolizumab.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Kai-Keen Shiu
Merck Sharp & Dohme Ltd
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.