A trial looking at atezolizumab with or without tiragolumab for oesophageal cancer (SKYSCRAPER 07)

Cancer type:

Oesophageal cancer

Status:

Open

Phase:

Phase 3

This trial is looking at giving atezolizumab with or without tiragolumab after chemoradiotherapy Open a glossary item. It is for people:

  • who can’t or don’t want surgery and 
  • whose cancer has not got worse after chemoradiotherapy

More about this trial

Having chemotherapy and radiotherapy together is chemoradiotherapy. This is the standard treatment for people with oesophageal cancer that can’t have or don’t want to have surgery. 

Atezolizumab is an immunotherapy Open a glossary item called a check point inhibitor. It works by blocking a protein that stops the immune system Open a glossary item attacking cancer cells. Doctors already use it for other cancers. 

Tiragolumab is another checkpoint inhibitor. It works in the same way as atezolizumab. But it blocks a different protein. 

Blocking these proteins could stop the cancer from growing or shrink the cancer. 

Researchers think that atezolizumab by itself or in combination with tiragolumab could work well for people with oesophageal cancer. In this trial people will have one of the following after their chemoradiotherapy:

  • atezolizumab and tiragolumab
  • atezolizumab and a dummy drug (placebo Open a glossary item)
  • 2 dummy drugs 

The aims of this trial are to find out:

  • how well the combination of atezolizumab and tiragolumab works
  • how well atezolizumab works on its own
  • more about the side effects
  • how these treatments affect quality of life Open a glossary item

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:

  • squamous cell oesophageal cancer that has spread into the surrounding tissue (stage 2 to stage 4a) that can’t be removed by surgery or you don’t want to have surgery to remove it. You might be able to take part if you are stage 4b, your doctor will know and be able to tell you. 
  • have had chemoradiotherapy for oesophageal cancer 
  • have a sample of tissue (biopsy Open a glossary item) that was taken before having chemoradiotherapy that the trial team can ask for
  • are active but might not be able to do heavy physical work (performance status 0 or 1)
  • have satisfactory blood test results
  • are willing to use 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:

  • adenocarcinoma, small cell or mixed cell cancer of the oesophagus
  • have had part or all the oesophagus removed 
  • have cancer that is completely blocking the oesophagus that can’t be treated
  • have cancer that has grown into the windpipe or into a major blood vessel
  • have pain caused by the cancer that can’t be controlled by medication
  • have had another type of cancer in the past 2 years. This is apart from successfully treated in situ carcinoma Open a glossary item of the cervix, non melanoma skin cancer Open a glossary item, early prostate cancer and early cancer Open a glossary item of the womb 
  • have a high risk of developing an abnormal opening between the oesophagus and another part of the body or to the outside of the body. Your doctor will be able to tell you if this is the case. 
  • have already had an immunotherapy called a checkpoint inhibitor
  • have ongoing moderate to severe side effects from chemoradiotherapy 
  • have had treatment with another experimental drug with the aim to cure the cancer  

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

  • have fluid around the heart, on the lungs or on the abdomen that needs to be drained every month or more
  • have the Epstein-Barr virus. Your doctor does a blood test for this. 
  • have an autoimmune disease Open a glossary item. You might be able to take part if you have certain autoimmune diseases that are controlled. Your doctor will know about this. 
  • have a low resistance to infection (immune deficiency) 
  • have lung problems such as an infection or scarring of the tissue
  • have tuberculosis (TB), HIV, hepatitis B, hepatitis C, another severe infection or you are being treated with antibiotics
  • have had a donor stem cell transplant or an organ transplant
  • have medication that stimulates the immune system within 4 weeks of being put into a treatment group for this trial (randomisation)
  • have medication that damps down the immune system within 2 weeks of randomisation. This is unless the dose is low or apart from certain medications that your doctor will know about. 
  • have heart problems Open a glossary item such as a heart attack that could affect you taking part
  • have major surgery within 4 weeks of starting treatment
  • have any other medical condition or mental health problem that your doctor or the trial think could affect you taking part
  • are allergic to atezolizumab, tiragolumab any of their ingredients or what goes into making them

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

  • have a live vaccine Open a glossary item within 4 weeks of starting treatment or might have it within 5 months after finishing treatment
  • are pregnant or breastfeeding
     

Trial design

This is an international phase 3 trial. The team need 750 people worldwide to take part with 18 people from the UK.

It is a randomised double blind trial. You go into 1 of 3 treatment groups. Neither you nor your doctor can choose which group you are, or know which group you are in. But if necessary, your doctor can find out which group you are in. 

The groups are: 

  • atezolizumab with tiragolumab
  • atezolizumab with a dummy drug (placebo)
  • a dummy drug with a dummy drug

 You have atezolizumab, tiragolumab and the dummy drugs as a drip into a vein. You have treatment every 3 weeks. Each 3 week period is a cycle of treatment Open a glossary item

You have 17 cycles of treatment (about 1 year) as long as your cancer doesn’t get any worse. 

Research samples
You give tissue samples and blood samples at the start and during the trial. Researchers will use these to look at substances (biomarkers Open a glossary item) that might tell them how well the treatment is working.

Some of these samples you must agree to and some you don’t. Your doctor will tell about them. 

Quality of life
You fill in a questionnaire:

  • every 3 weeks 
  • and then every 3 months for a year after finishing treatment

The questions ask about:

  • your general health
  • what you can do
  • symptoms
  • side effects

These are quality of life questionnaires

Hospital visits

You see the doctor to have tests before taking part. These tests include:

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

You see the doctor every 3 weeks while having treatment. This is to see how you are and for bloods. 

You have a CT scan or MRI scan:

  • every 6 weeks for 48 weeks and then
  • every 12 weeks after that

You stop having scans if your cancer gets worse.

Within a month of finishing treatment you see the doctor for:

  • a physical examination
  • bloods 
  • heart trace

Your doctor will then tell you how often they want to see 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

Tiragolumab and atezolizumab can affect the immune system. They may cause inflammation in different parts of the body. This can cause serious side effects. These could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.
 
If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

 

Tiragolumab is a new drug so there may be side effects we don’t know about. The side effects we know about so far include:

  • an allergic reaction causing fever, chills, shortness of breath, sickness, and changes in blood pressure
  • an increased risk of infection 

You may have some medication before tiragolumab to reduce the risk of having a reaction to the infusion.

We have information on:

Your doctor or a member of the trial team will talk to you about the side effects of the treatments in this trial before you agree to take part.
 

Location

Bournemouth
Cambridge
Dundee
Liverpool
London
Sutton
Swansea
Wolverhampton

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:

17361

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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