A study of durvalumab for advanced cancer of the food pipe (CALIBRATION)

Cancer type:

Oesophageal cancer
Secondary cancers

Status:

Open

Phase:

Pilot

This study is measuring circulating tumour DNA to find out how well durvalumab is working for people with cancer of the food pipe (oesophagus). 

It is for people with cancer of the food pipe that has spread elsewhere in the body. Or continued to grow despite treatment and can’t be removed with an operation. This is locally advanced or advanced cancer.

More about this trial

Cancer cells release small pieces of genetic material (DNA Open a glossary item) into the blood. This is called circulating tumour DNA (ctDNA). Doctors have developed a test that looks for ctDNA in the blood. 

In this study, doctors are looking at durvalumab for people with advanced oesophageal cancer. It is a type of immunotherapy. It stimulates the body’s immune system Open a glossary item to fight cancer cells. 

Researchers plan to measure ctDNA levels in the blood soon after starting treatment. They want to see if changes in the levels of ctDNA can predict how well durvalumab will work. A CT scan Open a glossary item is a usual way to check how treatment is working. But the blood test means it will be possible to check earlier on if treatment is working or not. Finding this out early can avoid people having unnecessary treatment.

The main aim of the study is to find out if the blood test can give an early sign about how well treatment is working. 

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. 
 
You:
  • have had at least one course of standard treatment Open a glossary item for oesophageal cancer
  • have cancer that the doctors can measure on a scan
  • have an area of cancer that the study team can take a tissue sample (biopsy Open a glossary item) from 
  • 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 90 days afterwards if there is any chance you or your partner could become pregnant 
  • are at least 18 years old 
Who can’t take part
You cannot join this study if any of these apply. 
 
Cancer related
You:
  • have cancer that has spread to the brain and is causing symptoms (you can take part if you have had treatment, it is stable and you haven’t had steroids in the last 4 weeks)
  • have cancer in the tissues around the brain (leptomeningeal carcinomatosis)
  • are having chemotherapy Open a glossary item, immunotherapy Open a glossary item targeted drugs Open a glossary item or hormone treatment Open a glossary item for oesophageal cancer
  • have had an immunotherapy drug in the past such as nivolumab or pembrolizumab  
  • are taking part in another clinical trial
  • have had radiotherapy to a large area of your body or to more than 30% of the bone marrow Open a glossary item in the last 4 weeks
  • have had any other cancer in the last 3 years apart from basal cell skin cancer Open a glossary item, squamous cell skin cancer Open a glossary item, early prostate cancer or CIS Open a glossary item of the cervix that has been successfully treated 
Medical conditions
You: 
  • have had an autoimmune condition Open a glossary item or inflammatory disease apart from vitiligo within the last 3 years, for example, Chron’s disease, active pneumonitis or lupus
  • have moderate side effects from past treatment that aren’t getting better apart from hair loss or vitiligo
  • have had an organ transplant and you need to take drugs that damp down the immune system Open a glossary itemsuch as steroids or methotrexate
  • have a problem with your immune system and it doesn’t work well
  • have heart problems such as congestive heart failure, high blood pressure or angina that isn’t well controlled with medication 
  • have a condition called interstitial lung disease
  • are having antibiotics for an active infection 
  • have active tuberculosis Open a glossary item
  • have an active hepatitis B or hepatitis C infection 
  • have had surgery in the last 4 weeks
  • have any other medical condition or mental health problem that the study team think would affect you taking part
Other
You:
  • are allergic or sensitive to durvalumab
  • have had a live vaccination Open a glossary item within the last 30 days
  • weigh less than 30kg
  • are pregnant or breastfeeding

Trial design

This pilot study is taking place in the UK. The researchers need 19 people to take part.
 
Everyone has durvalumab. You have durvalumab as a drip into a vein. It takes about an hour each time. You have it once every 4 weeks. 
 
You have treatment for as long as it is working and the side effects aren’t too bad. 
 
When you finish treatment, you see a doctor 1 month later for a check up. 
 
The study team will contact your GP 3 months after your last treatment to see how you are. 
 
Samples for research
You give some extra blood samples during treatment. You give them at specific times and the study team will give you more information about this. They plan to use the samples to:
  • see how well treatment is working
  • find out what happens to the drugs in the body
  • look for biomarkers Open a glossary item to predict who will benefit from treatment
The doctors will ask if they can collect 3 extra tissue samples if you are well enough. 

Hospital visits

You see a doctor and have some tests before you can take part. These include:
  • physical examination
  • blood samples
  • urine samples
  • heart trace (ECG Open a glossary item)
  • CT scan 
You might also need to have an MRI scan of your brain. You may need to give another tissue sample if there isn’t one available. 
 
You go to hospital for blood tests:
  • once every week for 4 weeks
  • every 2 weeks for 4 weeks
  • once a month after that
You also have check ups with the doctor at some of these appointments.
 
During treatment, you have a CT scan:
  • at 3 months 
  • at 6 months 
  • every 3 months after that

Side effects

The study team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything. 
 
The most common side effects of durvalumab are:
This treatment affects the immune system. This 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. In some people, these side effects could be life threatening.
 
For example: you may develop:
  • very bad diarrhoea (inflammation of the bowel)
  • shortness of breath and a cough (lung inflammation or pneumonitis)
Contact the study team or advice line as soon as possible if:
  • you have severe side effects
  • your side effects aren’t getting any better
  • your side effects are getting worse
Early treatment can help manage side effects better.

Location

Cambridge

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 Simon Pacey

Supported by

AstraZeneca
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16301

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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