Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
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 
. 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 called a check point inhibitor. It works by blocking a protein that stops the 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 ) - 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
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 ) 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 of the cervix, non melanoma skin cancer , early prostate cancer and early cancer 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 . 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 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 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 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 () 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:
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. |
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
If you have questions about the trial please contact our cancer information nurses
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.
Around 1 in 5 people take part in clinical trials
