
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This trial is comparing the drugs RO7121661, RO7247669 and nivolumab for cancer of the food pipe (oesophagus).
It is for people whose cancer has got worse or has come back after treatment.
Nivolumab is an immunotherapy. It helps your find and kill cancer cells. You might have nivolumab to treat cancer of the food pipe (oesophageal cancer) that has spread or come back after surgery.
Researchers are looking for ways to improve treatment for people whose cancer has spread or come back. In this trial they are looking at new immunotherapy drugs. They are called RO7121661 and RO7247669. They block different proteins on the surface of T cells.
Doctors aren’t sure how well RO7121661 and RO7247669 will work so they are running this trial to find out more. In this trial you have 1 of the following:
The main aims of the trial are to find out:
The following bullet points are a summary of 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:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This phase 2 trial is taking place worldwide. The team need to find 255 people to take part including 26 from the UK.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in. Nor will they know which group you are in. They can find this out if necessary.
There are 3 treatment groups. You have 1 of the following:
You have RO712161, RO7247669 or nivolumab as a drip into a vein. You have treatment once every 2 weeks. You have it for up to 2 years as long as it is working and the side effects aren’t too bad.
Samples for research
You give some extra blood samples during treatment. You give the samples at specific times and the trial team will give you more information about this. They also ask to use a sample of tissue from a previous biopsy or surgery.
They plan to use the samples to:
The team would also like to collect 2 extra tissue samples. You can say no to these samples if you don’t want to give them. It won’t affect you taking part in the rest of the trial.
The team might also ask you to give a tongue scrape sample, a poo sample and a spit (saliva) sample. You don’t have to agree to give these if you don’t want to.
Quality of life
The trial team ask you to fill out a questionnaire:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial doctor and have some tests before you can take part. These include:
These tests may be done over several days.
During treatment you see the trial doctor every 2 weeks for a check up and blood tests.
You have a CT scan or MRI scan:
When you finish treatment you see the doctor 1 month later for a check up.
Follow up
The team follow you up every 3 months when you finish treatment. You might see them at a routine hospital appointment. Or they may call you to see how you are getting on. They may also check your medical notes to see if you have started another cancer treatment. Some people may need to have more CT or MRI scans. The trial team will let you know if this applies to you.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
RO7121661, RO7247669 and nivolumab can affect the immune system. They may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. If you have any of these side effects please tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
RO7121661 and RO7247669 are new drugs. Only a few people have had them. So there might be side effects we don’t know about yet.
Possible side effects of similar drugs include:
You may have medication to lower the chance of these side effects developing. Your trial doctor or the research team will keep a close eye on you while you are having treatment and for some time afterwards. They will treat any problems straight away.
The trial doctor will talk to you about all the possible side effects of treatment.
We have more information about nivolumab and its side effects.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Elizabeth Smyth
Roche
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”