
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at adding pembrolizumab to chemotherapy for cancer of the bile duct or gallbladder (the biliary tract).
It is for people whose cancer:
This is advanced cancer.
Bile duct cancer and gallbladder cancer are known as biliary tract cancers.
Doctors treat advanced biliary tract cancer with chemotherapy. The usual treatment includes the chemotherapy drugs gemcitabine and cisplatin. Doctors want to improve treatment for people with advanced biliary cancer. In this trial they are looking at adding a drug called pembrolizumab to chemotherapy.
Pembrolizumab is an . It works by blocking a protein called PD-L1. This helps the body’s
to recognise and kill cancer cells.
In this trial some people have pembrolizumab, gemcitabine and cisplatin. And some have a dummy drug (, gemcitabine and cisplatin. Researchers think that having pembrolizumab with chemotherapy might work better. But they aren’t sure so want to find out more.
The main aims of the trial are to:
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:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This phase 3 trial is taking place worldwide. The researchers hope to find 788 people to take part including 33 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 can choose which group you are in. And neither you nor your doctor know which group you are in. It is a double blinded trial.
You have 1 of the following:
You have all the drugs as a drip into a vein. You have . Each 3 week period is a cycle of treatment.
The first day of each cycle is called day 1. On day 1 you have:
On day 8 you have:
You have treatment for up to 2 years as long as it is working and the side effects aren’t too bad.
Some people might continue to have treatment for another year. The trial doctor can tell you more about this.
Samples for research
The researchers ask for samples of your cancer (a ) that you gave when you had surgery or a previous biopsy. 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 look at:
The team might also ask to collect poo samples. But you don’t have to agree to give these samples if you don’t want to.
Quality of life questionnaires
The team ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a .
You see the doctor and have some tests before taking part. These include:
You might need to give a tissue sample if there isn’t one available.
You have a CT or MRI scan every:
Follow up
When you stop treatment you see the team 1 month later for a check up.
When you stop treatment and your cancer hasn’t got worse, you see the team every 6 to 12 weeks for a check up.
If the cancer has got worse, they’ll follow you up every 3 months to see how you are getting on. This might be at a routine hospital appointment or they might phone you.
The 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.
Pembrolizumab 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. Rarely, these side effects could be life threatening.
If you have any of these side effects, you should tell the doctor or nurse as soon as possible. You should tell them that you are on, or have been on, an immunotherapy.
Some of the common side effects of pembrolizumab are:
We have information about the side effects of:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr John Bridgewater
Merck Sharp & Dohme
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.