A trial of nivolumab and ipilimumab for stomach cancer and gastro oesophageal junction cancer (CA209-649)

Cancer type:

Oesophageal cancer
Stomach cancer

Status:

Open

Phase:

Phase 3

This trial is for people whose stomach or gastro oesophageal junction (where the food pipe joins the stomach) cancer has spread or can’t be removed by surgery. This is advanced or metastatic cancer.

More about this trial

Chemotherapy can be used to treat advanced and metastatic cancer of the stomach and gastro oesophageal junction Open a glossary item.
 
Nivolumab (Opdivo) and ipilimumab (Yervoy) are types of immunotherapy. They help the immune system Open a glossary item recognise and kill cancer cells.
 
In this trial researchers want to compare:
  • nivolumab and ipilimumab
  • nivolumab and standard chemotherapy
  • standard chemotherapy Open a glossary item
They want to find:
  • which treatment works best for people with stomach or gastro oesophageal junction cancer
  • how safe and acceptable it is to give nivolumab and ipilimumab
  • how safe and acceptable it is to give nivolumab and chemotherapy

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.
 
Who can take part
You may be able to join this trial if all of the following apply.
  • You have stomach (gastric) cancer or cancer where the food pipe (oesophagus) joins the stomach (gastro oesophageal junction cancer)
  • Your cancer can’t be removed by surgery or has spread into the surrounding tissue (advanced) or has spread to another part of the body (metastatic)
  • You have at least 1 area of cancer that can be measured on a CT scan Open a glossary item or MRI scan Open a glossary item
  • A sample of cancer tissue (biopsy Open a glossary item) is available for the trial team or you must be willing to have a biopsy done
  • You have satisfactory blood test results
  • You are able to do all your daily activities apart from heavy physical work (performance status 0 or 1)
  • You must be willing to use reliable contraception during treatment and for up to 7 months afterwards if you or your partner could become pregnant
  • You are at least 18 years old
Who can’t take part

You cannot join this trial if any of these apply.

Cancer related

  • Your cancer has receptors for HER2 Open a glossary item (is HER2 positive)
  • You have had chemotherapy, radiotherapy or chemoradiation Open a glossary item in the past 6 months before being put (randomised Open a glossary item) into a treatment group for this trial, if you had radiotherapy to relieve symptoms (palliative radiotherapy) it must be finished at least 2 weeks before you are randomised
  • Your cancer has spread to the brain or spinal cord unless it has been treated and there have been no symptoms for 2 weeks before being randomised and you must not be taking steroids or be on a stable dose or a decreasing dose of 10mg or less for 2 weeks before being randomised
  • You have had treatment that reached your whole body (systemic treatment) such as chemotherapy for cancer that has spread into the surrounding tissue (advanced) or to another part of the body (metastatic)
  • You still have side effects of previous cancer treatment apart from mild hearing loss, hair loss or tiredness (fatigue)
  • You have fluid collected in the abdomen (ascites) that can’t be controlled
Medical conditions
  • You have had another cancer in the past 3 years apart from an early cancer Open a glossary item that has been successfully treated such as non melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the breast, prostate or cervix
  • You have an autoimmune disease Open a glossary item apart from type 1 diabetes, an underactive thyroid gland that only needs hormone replacement, skin conditions such as vitiligo and psoriasis or hair loss (alopecia) 
  • You are taking steroids or other medication that affects the immune system within 2 weeks of starting treatment in this trial apart from inhalers, steroid creams and 10 mg or more dose of steroids to replace adrenal gland hormones
  • You have had treatment that works in a similar way to nivolumab and ipilimumab
  • You have nerve damage (neuropathy) that is moderate to severe
  • You have another medical or mental health condition that the trial team thinks could affect you taking part in the trial
  • You have HIV, hepatitis B or hepatitis C

Other

  • You are allergic or very sensitive to drugs, or any of their ingredients, used in this trial
  • You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The trial team need 12 people from the UK to join and a total of 1,226 worldwide. 
 
It is a randomised trial. Everyone taking part is put into 1 of 3 treatment groups. Neither you nor your doctor can choose which group you are in:
  • nivolumab and ipilimumab
  • nivolumab and standard chemotherapy
  • standard chemotherapy

CA 209-649 trial diagram

Nivolumab and ipilimumab
You have nivolumab and ipilimumab as a drip into a vein every 3 weeks. 
 
After 4 treatments you continue to have nivolumab only every 2 weeks. You continue with nivolumab for up to 2 years as long as it is helping and the side effects aren’t too bad.
 
Nivolumab and standard chemotherapy
The standard chemotherapy is XELOX or FOLFOX. Your doctor will discuss with you which is the best chemotherapy for you. 
 
XELOX is oxaliplatin and capecitabine. You have oxaliplatin as drip into a vein every 3 weeks. Capecitabine is a tablet you take twice a day with food. You take it for 2 weeks and have 1 week of not taking it. Each 3 week period is a cycle of treatment
 
You continue having treatment as long as it is helping and the side effects aren’t too bad. 
 
FOLFOX is oxaliplatin, leucovorin and fluorouracil. You have all of these as a drip into a vein. You also have fluorouracil as a continuous drip through a pump over the next 2 days. You have this every 2 weeks. Each 2 week period is a cycle of treatment. 
 
You continue treatment as long as it is helping you and the side effects aren’t too bad. 
 
You have nivolumab at the start of each cycle. You continue to have nivolumab for up to 2 years as it is helping and the side effects aren’t too bad.
 
Standard chemotherapy
You have XELOX or FOLFOX as above. 
 
Quality of life
You fill in a few questionnaires:
  • before starting treatment
  • every 6 weeks during treatment
  • every 3 months 
 
Blood and tissue samples
The team will take a number of blood samples during treatment. This to see what happens to nivolumab and ipilimumab in the body. 
 
You might need to have a tissue sample (biopsy) taken. If you had a biopsy taken in the last 6 months and a suitable sample is available, your doctor might be able to use this.   
 
The trial team use the sample to look for a certain protein (biomarker Open a glossary item) that might show how well treatment is working.

Hospital visits

You see the doctor to have some tests before taking part. These tests include:
  • a physical examination
  • blood tests
  • heart trace (ECG Open a glossary item)
  • CT scan or MRI scan
Depending on which treatment you have you see the doctor every 2 or 3 weeks for a physical examination and to see how you are. You have a CT scan or MRI scan every 6 weeks for about a year and then every 3 months until your cancer starts to grow again. 
 
After treatment you see the doctor every 3 months.

Side effects

The most common side effects of nivolumab include:

The most common side effects of nivolumab with ipilimumab include:

We have information on:
Your doctor will talk to you about the side effects of all the treatments in the trial before you agree to take part.

Location

Manchester
Nottingham
Southampton
Surrey

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 Ian Chau

Supported by

Bristol-Myers Squibb

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14772

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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