A trial of pembrolizumab for advanced cancer of the food pipe (oesophagus) KEYNOTE 181

Cancer type:

Oesophageal cancer

Status:

Open

Phase:

Phase 3

This trial is for people with oesophageal cancer that has spread into the surrounding tissue (locally advanced) or to another part of the body (metastatic). It is also open to people with advanced gastro oesophageal junction cancer

More about this trial

Chemotherapy is a common treatment for advanced oesophageal cancer. Unfortunately for some people their cancer continues to grow during treatment. For these people the doctor might try a different chemotherapy drug. 

Researchers think that a drug called pembrolizumab might be better than chemotherapy for these people.

Pembrolizumab is a type of biological therapy called a monoclonal antibody. It helps the immune system Open a glossary item to recognise and attack cancer cells. It is already used to treat some other types of cancer such as advanced melanoma. 

In this trial pembrolizumab will be compared with standard chemotherapy for advanced oesophageal cancer:

The main aim of this trial is to find if pembrolizumab is a better treatment for advanced oesophageal cancer and advanced gastro oesophageal junction cancer.

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 may be able to join this trial if all of the following apply:

  • you have oesophageal cancer that is an adenocarcinoma or a squamous cell type or a gastro oesophageal junction cancer that is a type1 adenocarcinoma (if your gastro oesophageal junction cancer tested positive for HER2 Open a glossary item your cancer must have continued to get worse while being treated with trastuzumab)
  • your cancer has spread into the surrounding tissue (locally advanced) or to another part of the body (metastatic) and can’t be removed with surgery 
  • you are willing to have a small piece of tissue (biopsy Open a glossary item) taken from your cancer
  • your cancer started to grow during your first line of treatment Open a glossary item
  • you have an area of cancer that can be measured on a scan
  • you have satisfactory blood test results
  • you are able to do most things apart from heavy physical work (performance status 0 or 1)
  • you are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any chance you or your partner could become pregnant
  • you are at least 18 years old

You cannot join this trial if any of these apply:

  • you have cancer spread to the brain or spine unless it has been treated, there are no symptoms and it has been stable for at least 4 weeks before joining the trial
  • you have had any other anti cancer treatment within 2 weeks of joining the trial 
  • you have had an experimental drug as part of another clinical trial in the past month 
  • you have already had treatment with a similar drug
  • you have taken part in another clinical trial of pembrolizumab
  • you still have side effects from any previous treatment apart from mild hair loss or nerve damage Open a glossary item 
  • you have had another cancer in the past 5 years apart from successfully treated non melanoma skin cancer Open a glossary item or in situ carcinoma Open a glossary item of the cervix or breast
  • you have an autoimmune disease Open a glossary item that has needed treatment in the past 2 years apart from taking medication to replace substances in the body such as thyroxine and insulin
  • your immune system Open a glossary item isn’t working well  
  • you have had medication that affects your immune system such as steroids within the week of starting treatment in the trial 
  • you have had a live vaccine Open a glossary item within 30 days of starting treatment in the trial
  • you have HIV, hepatitis B or hepatitis C
  • you have an infection needing treatment such as antibiotics that reach the whole body (systemic treatment)
  • you have a disease of the tissue surrounding the air sacs of the lung (interstitial lung disease) or inflammation of the lining of the air sacs (pneumonitis)
  • you have any other medical or mental health condition that the trial team think could affect you taking part
  • you are allergic or sensitive to any of the drugs or their ingredients used in this trial
  • you are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need about 18 people in the UK to take part.   

This is a randomised trial. People taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in: 

  • pembrolizumab
  • doctors choice of standard treatment Open a glossary item

Diagram for KEYNOTE 181

You have pembrolizumab as a drip into a vein. You have it every 3 weeks. Each 3 week period is called a cycle of treatment

You can have up to 2 years of treatment (35 cycles) if it is helping and the side effects aren’t too bad. 

After this you might be able to have another year of treatment if your cancer starts to grow again. Your doctor will talk to you about this. 

For the standard chemotherapy your doctor can choose to give you one of the following:   

All of these are given as a drip into a vein. 

You have paclitaxel once a week for 3 weeks and then a week of not having it. This 4 week period is a cycle of treatment. 

You have docetaxel once every 3 weeks. Each 3 week period is a cycle of treatment.

You have irinotecan once every 2 weeks. Each 2 week period is a cycle of treatment. 

You continue to have treatment as long as it is helping and the side effects aren’t too bad. 

Quality of life 
The trial team will ask you to fill in a questionnaire for the first 7 cycles of treatment and then every 3 cycles of treatment for a year. The questions will ask you about how you are feeling and any side effects. This is a quality of life study

Blood samples
The researchers will ask for some extra blood samples. They use these to 

  • find what happens to pembrolizumab in the body
  • look for substances (biomarkers Open a glossary item) that might tell how well pembrolizumab is working
  • look at the genes Open a glossary item in your cells to understand how they might affect how well your cancer responds to pembrolizumab

Hospital visits

You see the doctor to have some tests before taking part. These tests include 

  • a physical examination
  • blood tests
  • urine test 
  • heart trace (ECG Open a glossary item)
  • MRI scan or CT scan

During treatment you see the doctor at the start of each cycle of treatment for a physical examination and blood tests. You have a CT scan or MRI scan every 9 weeks. 

When you finish treatment you see the doctor for the same tests you had at the start apart from the heart trace. 

After treatment you either see the doctor or a member of the trial team will call you every 9 weeks until your cancer starts to get grow again. You will be asked to have a scan every 9 weeks. 

If you stop treatment because your cancer has grown, then a member of the trial team will contact you by phone about every 12 weeks to see how you are doing.

Side effects

The most common side effects of pembrolizumab are 

We have more information about pembrolizumab

We have information on the side effects of 

Your doctor will talk to you about the side effects of all the drugs before you agree to take part.

Location

Aberdeen
London
Manchester

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

Dr Wasat Mansoor

Supported by

Merck, Sharp & Dohme

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14101

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

A picture of Wendy

"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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