A trial of bevacizumab and atezolizumab for pleural mesothelioma (BEAT-meso)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Mesothelioma
Secondary cancers
Status:
Closed
Phase:
Phase 3
This trial is looking at adding atezolizumab to the usual treatment for pleural mesothelioma that has spread.
Pleural mesothelioma is cancer of the outer lining of the lung.
More about this trial
Mesothelioma can spread elsewhere in the body. This is called advanced cancer. The usual treatment for advanced pleural mesothelioma is chemotherapy. You might also have a targeted drug called bevacizumab. It is a type of monoclonal antibody.
In this trial, researchers are looking at adding a drug called atezolizumab.
Atezolizumab is a type of immunotherapy drug. It works by stimulating the body’s immune system 
to recognise and kill cancer cells.
to recognise and kill cancer cells.Some people will have chemotherapy and bevacizumab. And some will have chemotherapy, bevacizumab and atezolizumab.
The main aims of the trial are to:
- see if adding atezolizumab to chemotherapy and bevacizumab improves treatment
- find out more about the side effects
- find out more about
quality of life
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 pleural mesothelioma that has spread into surrounding tissues or elsewhere in the body
- have pleural mesothelioma that your doctor can see on a scan
- have a tissue sample (
biopsy ) available for the trial team to do some tests on - can carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
- have satisfactory blood test results
- are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any chance you or your partner could become pregnant
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
- are suitable to have surgery to remove the cancer
- have already had treatment for pleural mesothelioma
- have already had treatment with an immunotherapy drug including
interferon or interleukin in the last 4 weeks or the drugs haven’t completely cleared your body - have pleural mesothelioma that has grown into the large blood vessels in the chest
Medical conditions
You:
- are having or have had treatment that dampens down your
immune system within 2 weeks of starting trial treatment (you may still take part if you are taking a low dose of the steroid drug prednisolone) - have had a transplant with someone else’s cells (
allogeneic transplant ) or an organ transplant [Gloss/Organ transplant] - have high blood pressure or very high blood pressure in the past that affected brain function (hypertensive crisis)
- have had a problem with your blood vessels such as a bulge or swelling in the aorta (an aortic aneurysm) within 6 weeks of joining the trial
- have vomited blood with 1 month of joining the trial or had a significant bleeding disorder in the past
- are taking medication to thin the blood such as warfarin unless your blood clotting has been stable for the last 2 weeks
- have had aspirin within 10 days of starting trial treatment
- have had a minor surgical procedure within 7 days of starting bevacizumab
- have a wound or ulcer that hasn’t healed or an untreated bone fracture
- have had a severe allergic reaction to a
platinum drug , pemetrexed, bevacizumab or atezolizumab in the past - have moderate numbness or tingling in your hands or feet (
peripheral neuropathy ) - have HIV
- have an active hepatitis B or hepatitis C infection
- have any other medical condition or mental health problem that the trial team think would affect you taking part
Other
You:
- are pregnant or breastfeeding
- have had a live
vaccine within 4 weeks of starting trial treatment
Trial design
This phase 3 trial is taking place worldwide. The researchers need 320 people to take part including 90 from the UK.
It is a randomised trial. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
You have 1 of the following:
- chemotherapy and bevacizumab (group 1)
- chemotherapy, bevacizumab, atezolizumab (group 2)
You have all your treatment as a drip into a vein. Each 3 week period is a cycle of treatment.
Chemotherapy and bevacizumab (group 1)
Every 3 weeks you have:
- carboplatin chemotherapy
- pemextred chemotherapy
- bevacizumab
You have between 4 and 6 cycles of chemotherapy. This takes between 12 and 18 weeks. You have bevacizumab for as long as it is working, and the side effects aren’t too bad
Chemotherapy, bevacizumab, atezolizumab (group 2)
Every 3 weeks you have:
- carboplatin chemotherapy
- pemextred chemotherapy
- bevacizumab
- atezolizumab
You have between 4 and 6 cycles of chemotherapy. This takes between 12 and 18 weeks. You have bevacizumab and atezolizumab for as long as they are working, and the side effects aren’t too bad
Quality of life
The trial team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study
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 you to give a tissue sample if your cancer gets worse. They plan to use the samples to:
- see how well the treatment is working
- look for
biomarkers to predict who will benefit from treatment
The doctors will ask permission to store some of your blood and a pleural mesothelioma tissue sample. This is for future research.
Hospital visits
You see a doctor and have some tests before you can take part. These include:
- physical examination
- blood samples
- urine samples
heart trace - CT scan
You have treatment in the day unit at the hospital. At each visit you have some blood tests and see a doctor for a check up. You shouldn’t need to stay overnight.
You have a CT scan every 6 weeks until your pleural mesothelioma gets worse. You stop treatment if this happens. Your doctor will discuss other treatment options with you. The trial team will continue to follow you up every 12 weeks to see how you are and if you have started another treatment.
Side effects
Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:
- you have severe side effects
- your side effects aren’t getting any better
- your side effects are getting worse
Having chemotherapy, bevacizumab and atezolizumab is a new treatment combination for pleural mesothelioma. So, there may be some side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you have a phone number to call if you are worried about anything.
The most common side effects of atezolizumab are:
- fever
- feeling or being sick
- tiredness (fatigue) or lack of energy
- itchy skin or skin rash
- diarrhoea
- joint pain, muscle or bone pain
- loss of appetite
- shortness of breath
- urine infections
- cough
This treatment affects the immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.
The most common side effects of bevacizumab are:
- high blood pressure
- numbness or tingling in the hands or feet
- an increased risk of infection, bruising or bleeding
- feeling weak or having no energy
- tiredness (fatigue)
- diarrhoea
- feeling or being sick
- tummy (abdominal pain)
We have information about the side effects of:
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 Sanjay Popat
Supported by
European Thoracic Oncology Platform (ETOP)
F. Hoffmann - La Roche, Limited
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
16267
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
