A trial looking at nivolumab for cancer of the food pipe (CA209577)

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

Cancer type:

Oesophageal cancer

Status:

Closed

Phase:

Phase 3

This trial is for people with cancer of the food pipe (oesophagus) or the area where the food pipe joins the stomach (gastro oesophageal junction).

It is for people who have had:

a combination of chemotherapy and radiotherapy (chemoradiotherapy)
surgery

More about this trial

Cancers that start in the food pipe (oesophageal cancer) or in the area where the food pipe joins the stomach (gastro oesophageal junction cancer) are often treated with chemoradiotherapy and then surgery to remove all or part of the oesophagus.

After surgery, doctors look at the tissue removed. If they find cancer cells in the tissue, this is residual disease.

If you have residual disease you have a higher chance of the cancer coming back. So doctors are looking at a targeted cancer drug (biological therapy) called nivolumab to try to stop the cancer coming back.

Nivolumab (Opdivo) is a type of immunotherapy Open a glossary item . It works by blocking a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking this protein activates the T-cells to find and kill cancer cells.

In this trial you have 1 of the following:

nivolumab
dummy drug (placebo )

The main aims of this trial are to:

find out how good nivolumab is at stopping oesophageal cancer and gastro oesophageal junction cancer from coming back
learn more about the side effects of nivolumab
look for certain proteins to see why treatments work better for some people than others and why some people have more side effects than others
learn more about the quality of life

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 or gastro oesophageal junction cancer (stage 2 or stage 3)
You have had chemoradiotherapy with a platinum drug such as cisplatin
You have had surgery to remove all or part of your oesophagus more than 4 weeks but less than 14 weeks ago
Doctors found cancer cells in the tissue removed during surgery (residual disease) but there weren’t any cancer cells close to the edge of the tissue removed (negative margins). Your doctor will check this
You have had a physical examination and a CT scan or MRI scan of your chest and tummy (abdomen) less than 4 weeks ago and your doctor thinks that there isn’t any cancer left
You have a tissue sample of cancer available that was taken during surgery
You have satisfactory blood tests results
You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are at least 18 years old

Women must be willing to use reliable contraception during treatment and for 5 months afterwards if there is any possibility of becoming pregnant. Men must be willing to use reliable contraception during treatment and for 7 months afterwards if there is any possibility their partner could become pregnant

You cannot join this trial if any of these apply:

Cancer related

You have oesophageal cancer that started in the upper part of the food pipe (cervical oesophageal cancer)
Your oesophageal cancer has spread to other parts of the body such as the liver or lungs (stage 4)
You have had a cancer drug or radiotherapy after surgery to remove all or part of your oesophagus
You have had nivolumab or any other similar drug
You have side effects from previous anti cancer treatment apart from hair loss, hearing loss, tiredness, kidney problems or problems with your nerves that cause numbness and tingling in your skin
You have had another cancer in the last 3 years apart from successfully treated early cancers (carcinoma in situ) of the bladder, prostate, cervix and breast or successfully treated basal or squamous cell skin cancer

Medical conditions

You are sensitive to nivolumab or any other similar drug
You have an autoimmune disease unless it is vitiligo, type 1 diabetes, hair loss (alopecia), thyroid problems that are controlled by medications or a skin condition called psoriasis that doesn’t need treatment
You have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks (unless this was a cream, an inhaler or a very small amount of a steroid called prednisolone)
You have lung problems such as interstitial lung disease that is causing you symptoms
You have an infection that needs treatment
You have HIV
You have hepatitis B or hepatitis C
You have any other medical condition or mental health problem that the trial team thinks could affect you taking part in this trial

Other

You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need about 760 people worldwide and around 15 people from the UK to take part.

This trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:

nivolumab
dummy drug (placebo)

Neither you nor your doctor are able to decide which group you are in. And neither you nor your doctor will know which group you are in. This is a double blind trial Open a glossary item .

You are 2 times more likely to have nivolumab than the dummy drug.

study diagram

You have nivolumab or the dummy drug as a drip into a vein. You have it:

every 2 weeks for 16 weeks (about 4 months)
then every month for up to a year

It takes about 30 minutes each time.

Quality of life
Everybody taking part in this trial completes a quality of life questionnaire before starting treatment and then:

at set times during the trial
1 month after you finish treatment
every 3 months

It asks about how you have been feeling and what side affects you have had.

Blood tests
You have some extra blood tests as part of this trial. Researchers want to:

look for certain proteins called biomarkers to see why treatments work better for some people than others
find the amount of nivolumab in your body

You have the extra blood tests before starting treatment, at set times during the trial and if your cancer comes back.

Tissue sample
Researchers will ask to use a sample of your cancer taken during surgery. They want to look for certain proteins and genes Open a glossary item to find out more about oesophageal cancer and how the treatment works.

Doctors might also ask you to give a tissue sample (biopsy Open a glossary item ) if your cancer comes back.

Hospital visits

You see a doctor and have some tests before taking part. These tests include:

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

During treatment you see the trial doctor for blood tests and a physical examination every 2 weeks for 4 months. Then you see the doctor every month.

You have a CT scan or MRI scan every 3 months while you are having treatment.

You have treatment for as long as there are no signs of your cancer coming back and the side effects aren’t too bad. It can be for up to 1 year.

When you finish treatment you see the doctor after 1 and 3 months. You have blood tests and a physical examination.

You then see or speak with the trial team every 3 months. This continues for about 5 years.

You also have a CT scan or MRI scan:

every 3 months for 2 years
then every 6 to 12 months for 3 years

Side effects

The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

The most common side effects of nivolumab are: