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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Oesophageal cancer

Secondary cancers

Status:

Closed

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) 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 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 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 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) 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, immunotherapy targeted drugs or hormone treatment 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 in the last 4 weeks
have had any other cancer in the last 3 years apart from basal cell skin cancer, squamous cell skin cancer, early prostate cancer or CIS of the cervix that has been successfully treated

Medical conditions

You:

have had an autoimmune condition 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 such 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
have an active infection that needs treatment such as tuberculosis (TB), hepatitis B or hepatitis C, known HIV or coronavirus (COVID-19). And you may have had antibiotics in the last 2 weeks
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 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 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)
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:

feeling or being sick
loss of appetite
diarrhoea
tummy (abdominal) pain
tiredness (fatigue)
high temperatures (fever)
swelling of the body due to fluid retention
skin rash or itchy skin
chest infections, coughs and colds
shortness of breath
liver changes

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: