A trial looking at volrustomig and chemotherapy for mesothelioma of the lungs (eVOLVE-Meso)
Cancer type:
Status:
Phase:
This trial is comparing volrustomig and chemotherapy with
Volrustomig is pronounced vol-rus-to-mig. It is also called MEDI5752.
This trial is for people:
- having their first treatment for mesothelioma of the lungs and
- whose mesothelioma has spread elsewhere in the body and it isn’t possible to remove it with surgery
More about this trial
Mesothelioma is a type of cancer that can develop in the covering of the lungs. This is pleural mesothelioma or mesothelioma of the lungs. It can spread elsewhere in the body. This is advanced cancer.
There are several different standard treatment options to treat advanced mesothelioma. These include chemotherapy or a combination of 2
Doctors are looking for ways to improve treatment for advanced pleural mesothelioma. In this trial they are looking at a drug called volrustomig in combination with chemotherapy.
Volrustomig is a new immunotherapy. It blocks 2 different proteins on the cancer cells. Researchers hope that by blocking 2 proteins it might boost the ability of your immune system to detect and fight cancer. Doctors aren’t sure how well volrustomig and chemotherapy will work for pleural mesothelioma. So they are doing this trial to find out more.
In this trial you have one of the following:
- volrustomig and chemotherapy (new treatment)
- chemotherapy or nivolumab and ipilimumab. This is standard treatment.
The main aims of the trial are to find out:
- how safe it is to have volrustomig in combination with chemotherapy
- how well the combination of volrustomig and chemotherapy work
- more about the side effects of volrustomig in combination with chemotherapy
- how treatment affects
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:
- have mesothelioma of the lung (pleural mesothelioma) that has been confirmed with a tissue sample (
biopsy ) - have mesothelioma that has spread to another part of the body and you can’t have surgery to remove it with the aim to cure
- have pleural mesothelioma that your doctor can measure on a scan. The areas of mesothelioma must measure at least 7mm across. Or you have areas of mesothelioma that have spread elsewhere in the body that your doctor can measure on a scan.
- have a sample of tissue (biopsy) the trial team can access that you had done within 6 months of seeing if you are suitable for the trial. Please note, you may still be able to join the trial if there isn't a tissue sample available.
- have satisfactory blood test results
- are fully active but might not be able to do heavy physical work (performance status of 0 or 1). And this hasn’t got worse at the time of being assessed for the trial.
- are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- weigh at least 35kg (77lb)
- are willing not to donate sperm or eggs during the trial and for a period after
- 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 mesothelioma that didn’t start in the lining of the lungs
- have had treatment for mesothelioma of the lungs in the past that included chemotherapy, surgery or radiotherapy. You can take part if you had radiotherapy to treat mesothelioma symptoms if this was more than 2 weeks ago.
- have had immunotherapy or similar drugs in the past. You can take part if you have had a
cancer vaccine. - have had radiotherapy for another cancer to a wide area or to more than 30% of the
bone marrow within 4 weeks of starting trial treatment. Your doctor will be able to assess this. You can take part if you have had radiotherapy to help with symptoms. - have mesothelioma but your doctor can’t work out the cell type
- have had major surgery within 4 weeks of starting trial treatment or you aren’t better after surgery. You can take part if you had surgery to help with symptoms.
- have had chemotherapy, radiotherapy, an experimental treatment, a
targeted cancer drug orhormone treatment for another cancer. - have cancer that has spread to the brain, spinal cord or tissues that surround the brain or is pressing on the spinal cord (
spinal cord compression ). You might be able to take part if you have had treatment, the cancer is stable and you haven’t hadsteroids within 14 days of starting trial treatment - have had another cancer that has got worse or needed treatment in the past 2 years unless it has a low chance of coming back. You can join if it was successfully treated
non melanoma skin cancer ,lentigo maligna, carcinoma in situ (CIS ), early bladder cancer or prostate cancer that doesn’t need treatment. - are taking an experimental drug or using a device as part of another clinical trial. Or you are in the follow up period for a trial that involved a treatment.
Medical conditions
You cannot join this trial if any of these apply. You:
- have or had an
autoimmune condition that needed treatment apart from certain ones. Your doctor will know about this. - have had a heart attack in the last 12 months, a significant
heart problem that needs treatment or a problem with your heartbeat. The trial team check if you have a heart condition before you join the trial. - have high blood pressure that isn’t controlled with medication
- have scarring of the lungs (interstitial lung disease)
- have a serious problem with your gut (
digestive system ) - have an active bleeding problem
- have had a
stem cell transplant or anorgan transplant - have a problem with how your
immune system works - have had treatment that damps down the immune system. This includes steroids within 2 weeks of starting trial treatment unless it was a low dose
- have HIV, an active hepatitis B or hepatitis C infection that isn’t well controlled with medication, an active hepatitis A infection,
tuberculosis or any other severe infection that needs treatment - have any other severe or uncontrolled medical condition that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- have already joined this trial even if you didn’t have treatment
- have had a severe allergic reaction to a targeted cancer drug or cancer vaccine in the past
- are allergic to volrustomig or anything it contains
- can’t have pemetrexed, carboplatin or cisplatin chemotherapy for any reason
- have had a
live vaccination within 30 days of starting trial treatment. You can take part if you have had an approved COVID-19 vaccine as these aren’t live. - are pregnant or breastfeeding
Trial design
This phase 3 trial is taking place worldwide. The team need to find 600 people to take part including 40 from the UK.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.
You have 1 of the following:
- volrustomig and chemotherapy (new treatment)
- chemotherapy or nivolumab and ipilimumab (standard treatment)
You have all your treatment as a drip into a vein. You stop treatment if your cancer gets worse or if you have bad side effects.
Volrustomig and chemotherapy (new treatment)
You have volrustomig, pemetrexed and carboplatin chemotherapy once every 3 weeks. Volrustomig takes 60 minutes each time. Pemetrexed and carboplatin take 30 minutes each time. You will be at the hospital for longer than this.
You have pemetrexed and carboplatin for up to
You have volrustomig for up to 2 years.
Standard treatment
You have one of the following standard treatments:
- nivolumab and ipilimumab
- pemetrexed and carboplatin chemotherapy or pemetrexed and cisplatin chemotherapy
Your doctor decides which treatment will work best for you.
You have nivolumab once every 3 weeks. You have ipilimumab once every 6 weeks. You have this for up to 2 years.
Those having chemotherapy have it once every 3 weeks. You have up to 6
Samples for research
The researchers might ask you to give 2 extra tissue samples. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to:
- see how well the treatment is working
- see what happens to volrustomig in the body
- look at
genes to understand more about mesothelioma of the lung - look for substances called
biomarkers to help work out why treatment might work for some people and not for others
You can say no to giving the extra tissue samples and some of the blood samples. It won’t affect you taking part in the rest of the trial.
Quality of life
The trial team ask you to fill out a questionnaire on an app (electronic application). You do this on a mobile phone or tablet:
- before you start treatment
- at set times during treatment
- at set times after 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 doctor and have tests before you can take part. These include:
- blood tests
- urine test
- a
physical examination - heart trace (ECG)
- heart scan (
echocardiogram ) orMUGA scan - CT scan or MRI scan
During treatment you see the doctor regularly. This is for blood tests and to see how you are.
Trial scans
You have an MRI scan or CT scan:
- every 6 weeks for the first 2 years and then
- every 3 months
You stop having the trial scans if your cancer gets worse.
Follow up appointments
You see the trial team when you stop treatment at:
- 21 days
- 3 months
The team then follow you every 2 to 3 months for 3 years. You might see them at a routine hospital appointment or they may call you to see how you are getting on.
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.
Volrustomig, nivolumab and ipilimumab can affect the These side effects could happen during treatment or 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. |
Other possible side effects of volrustomig include:
- inflammation of the heart muscle which may cause chest pain, heart rate changes or the heart muscle not working well. Doctors can treat this but it is serious and can be life threatening.
- a reaction that can happen while you are having the infusion. This is called an infusion reaction. Signs include high temperatures (fever), chills, muscle pain or tenderness, feeling or being sick, itchy skin or skin rash, headache, flushing (redness of the skin), sweating, fast heartbeat, difficulty breathing, low blood pressure, dizziness or light-headedness.
- a severe
allergic reaction . This can happen while you are having volrustomig or up to 24 hours after you have it. antibodies to volrustomig- your body releasing a large amount of a substance called cytokines. This is called cytokine release syndrome. It includes symptoms such as high temperatures, headaches, skin rash, low blood pressure, low blood oxygen levels or a fast heartbeat. Your doctor can treat this but it is serious and can be life threatening.
- some types of white blood cells being made too fast and becoming too active
The trial team keep a close eye on you and treat any side effects straight away. They will talk to you about all the side effects of treatment. You’ll have a chance to ask any questions you may have.
We have more information about the following treatments and their side effects:
Location
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.
Chief Investigator
Professor Dean Fennell
Supported by
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040