A trial of RO7121661, RO7247669 or nivolumab for cancer of the food pipe (TALIOS)

Cancer type:

Oesophageal cancer
Secondary cancers

Status:

Open

Phase:

Phase 2

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.

More about this trial

Nivolumab is an immunotherapy. It helps your immune system Open a glossary item 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:

  • RO7121661 (this group is now closed to recruitment)
  • RO7247669
  • nivolumab 

The main aims of the trial are to find out:

  • how well RO7121661 and RO7247669 work compared to nivolumab
  • how safe it is to have RO7121661 or RO7247669
  • what the side effects are 
  • how it affects the body

Who can enter

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:

  • have squamous cell cancer Open a glossary item of the oesophagus that has spread into surrounding tissues or to another part of the body (advanced or metastatic cancer)
  • can’t have surgery to remove the cancer and you have had one course of chemotherapy Open a glossary item that stopped working after 3 cycles. The chemotherapy must have included a drug such as 5FU or capecitabine and a platinum drug Open a glossary item. Or the chemotherapy you had must have included a taxane Open a glossary item such as paclitaxel and a platinum drug.
  • have cancer that your doctor can measure on the scan 
  • have a sample of cancer tissue (biopsy Open a glossary item) available for the trial team to do some tests on
  • are fit and can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
  • have satisfactory blood test results  
  • are willing to use reliable contraception during treatment and for a time after if there is any chance you or your partner could become pregnant
  • are at least 18 years old

Who can’t take part

Cancer related 
You cannot join this trial if any of these apply. You:

  • have already had immunotherapy Open a glossary item or a similar drug 
  • have had CAR T-cell therapy in the past or a similar treatment 
  • have had radiotherapy within 28 days of starting trial treatment. You may be able to take part if you are having treatment for cancer symptoms.
  • have cancer that has spread to the brain or spinal cord unless it isn’t causing symptoms, has been treated and is stable
  • have cancer that is pressing on or near the spinal cord (spinal cord compression) Open a glossary item that hasn’t been treated and isn’t stable within 2 weeks of being put in a treatment group
  • have or have had cancer cells that have spread to the thin layers of tissue that cover the brain and spinal cord
  • have pain from cancer that isn’t well controlled 
  • have had an experimental treatment within 28 days of being put into a treatment group or the treatment hasn’t cleared your body yet 
  • have another cancer. This is apart from CIS Open a glossary item of the cervix, ductal carcinoma of the breast Open a glossary item, non melanoma skin cancer,  Open a glossary itemvery early melanoma skin cancer, or early prostate cancer that has been successfully treated. Or you may be able to take part if you had another early cancer and there have been no signs of it for at least 2 years. 

Medical conditions
You cannot join this trial if any of these apply. You:

  • have had a significant heart problem Open a glossary item such as a heart attack within 6 months of being put into a treatment group
  • have had a stroke Open a glossary item or mini stroke within 6 months of being put into a treatment group
  • have liver problems Open a glossary item
  • are poorly nourished (have malnutrition) 
  • have a blockage in your food pipe and you can’t have treatment to fix this
  • have a high risk of bleeding or a fistula Open a glossary item caused by areas of cancer in the food pipe
  • have uncontrolled fits (seizures) or you have had a serious infection in your brain in the last year 
  • have had treatment that dampens down the immune system Open a glossary item within 28 days of being put into a treatment group. This doesn’t include having low dose steroids. 
  • have had major surgery or a serious injury within a month of being put into a treatment group 
  • have areas of fluid on the lung or tummy that need to be drained often. This doesn’t apply if you have a long term drain in your lung. 
  • have an autoimmune disease Open a glossary item that needs treatment. This is apart from certain ones which your doctor will know about. 
  • have scarring in the lungs (fibrosis Open a glossary item) or other parts of the body 
  • have diabetes Open a glossary item 
  • have an active hepatitis B or hepatitis C infection, HIV or an infection that needs treatment within 14 days of starting trial treatment 
  • have moderate to severe side effects from past treatments that aren’t getting better. This doesn’t include hair loss, white patches on your skin, taking medication to replace hormones Open a glossary item or mild numbness or tingling in your hands and feet. 
  • have any other medical condition or mental health problem that the trial team think would affect you taking part

Other 
You cannot join this trial if any of these apply. You:

  • are allergic to RO7121661, RO7247669, nivolumab or anything they contain 
  • have had a live vaccine Open a glossary item within 30 days of the start of treatment or might need to have one during the trial.  Please note that the current approved COVID-19 vaccines aren’t live. 
  • are pregnant or breastfeeding

Trial design

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:

  • RO7121661 (this group is now closed to recruitment)
  • RO7247669 
  • nivolumab

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:

  • see how well the treatment is working 
  • look at genes Open a glossary item and DNA Open a glossary item on cancer cells to understand more about cancer of the food pipe
  • look for substances called biomarkers Open a glossary item to help work out why treatment might work for some people and not for others

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:

  • before you start treatment
  • at set times during treatment

The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the trial doctor and have some tests before you can take part. These include:

  • blood tests
  • urine tests
  • a physical examination Open a glossary item
  • heart trace (ECG Open a glossary item)
  • heart scan (echocardiogram Open a glossary item) or MUGA Open a glossary item scan
  • CT scan or MRI scan

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:

  • every 6 weeks for the first year and then
  • every 3 months in the second year of treatment 

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.

Side effects

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:

  • an allergic reaction. Symptoms include itchy skin, a skin rash, difficulty breathing, and or a drop in blood pressure.
  • a reaction to the drug while you are having it or within 24 hours of having it. Symptoms may include fever, shivering or chills, feeling or being sick, high blood pressure, an abnormal heartbeat, breathing problems, headache, low blood pressure, pain where the cancer is, restlessness, diarrhoea, dizziness, sweating, flushing, skin rash, and sudden reddening of the face, neck, or chest.
  • developing resistance to the drugs. If this happens symptoms may include a skin rash, joint and muscle pain, fever, and tiredness. 

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.

Location

London
Manchester
Nottingham
Oxford

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 Elizabeth Smyth

Supported by

Roche

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17781

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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