A trial looking at volrustomig for head and neck cancer that has spread into the surrounding tissue (eVOLVE-HNSCC)
Cancer type:
Status:
Phase:
This trial is looking at volrustomig (MEDI5752) for head and neck cancer that has spread into the surrounding tissue and cannot be removed by surgery.
Cancer that has spread into the surrounding tissue is called locally advanced cancer.
It is open to people who have had chemotherapy alongside radiotherapy (
) as treatment for the following:
- oropharyngeal cancer
- mouth (oral) cancer
- hypopharyngeal cancer
- laryngeal cancer
- tongue cancer
- tonsil cancer
You pronounce volrustomig as vole-rust-oh-mig.
More about this trial
The main treatment for locally advanced head and neck cancer that cannot be removed by surgery is chemoradiotherapy. Unfortunately for some people this does not work well. And for people in this situation there are not many treatment options left.
Researchers are looking for other treatments for these people. In this trial they are looking at volrustomig.
Volrustomig is an immunotherapy. It works by blocking 2 different proteins on the cancer cells. Researchers hope that blocking these proteins might boost the ability of your to detect and fight cancer.
To find out if volrustomig does help, half the people in this trial will have volrustomig and the other half won’t. Everyone taking part in the trial will have regular appointments with their doctor and a member of the trial team.
The aims of the trial are to find out:
- whether it is better having volrustomig after chemoradiotherapy than just having chemoradiotherapy
- more about volrustomig and its side effects
- how volrustomig 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 you have one of the following:
- oropharyngeal cancer
- mouth (oral) cancer
- cancer of the
hypopharynx - laryngeal cancer
- tongue cancer
- tonsil cancer
And all the following apply. You:
- have a
squamous cell type of cancer - have cancer that has grown into the nearby tissue or
lymph nodes (locally advanced) - have a sample of tissue (
biopsy ) that the team can use and do tests on. If this is not available, you must be willing to have a fresh biopsy taken. - have completed the standard of care
chemoradiotherapy with the aim to cure, within the 12 weeks before being put into a treatment group (randomisation ) - are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
- have satisfactory blood test results
- weigh more than 35kg (5st 6lb)
- are willing to use reliable contraception during treatment and for a period of time after if 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 cancer that has spread to another part of the body (metastatic cancer)
- had your standard of care chemoradiotherapy and your cancer has got worse or come back within the 12 weeks before randomisation
- have some cancer left after the chemoradiotherapy
- had surgery to remove the locally advanced cancer before having chemoradiotherapy
- had radiotherapy only
- have had a stem cell or bone marrow transplant from a donor (an
allogeneic transplant ) - have cancer that has spread to the brain, spinal cord or the tissue surrounding them. You can join if it has been treated and it is not getting worse.
- had another cancer. This is apart from an
early head and neck cancer that was removed by surgery 2 or more years ago and was not treated with radiotherapy or chemotherapy. Or you had any other cancer that was treated with the aim to cure 2 or more years ago and there has been no sign of it coming back. Or you had non melanoma skin cancer , lentigo maligna or a carcinoma in situ (CIS) that was successfully treated. Or you have early prostate cancer that does not need treatment. - have ongoing moderate to severe side effects from previous cancer treatment. This is apart from hair loss, vitiligo or any permanent side effects such as hearing loss that your doctor considers will not get any worse.
- have had an
immunotherapy . Your doctor will know this. - are having any cancer treatment including an experimental drug as part of another clinical trial. You can join if you are having hormone therapy for non cancer related conditions such as
HRT or insulin for diabetes. You can join if you are having treatment to relieve the symptoms of cancer as long as the cancer is not getting worse. - are taking herbal or natural preparations as a treatment or preventative for cancer
Medical conditions
You cannot join this trial if any of these apply. You:
- have active tuberculosis (TB) or any other active infection
- have HIV that is not controlled
- have active hepatitis A, active hepatitis B or hepatitis B that is not controlled, active hepatitis C or hepatitis C that is not controlled
- have had a major
heart problem such as a heart attack or unstable chest pain (angina) in the past year - have certain
digestive problems - have an active bleeding problem
- have had an
organ transplant - have or had an
autoimmune disease or inflammatory disease, apart from certain ones that your doctor will know about - have pressure on the spinal cord (
spinal cord compression ). You can join if it has been treated and it is not getting worse. - have medication that damps down the
immune system within 14 days of starting treatment. This is apart from certain ones such as inhalers and creams. Your doctor will know more about this. - have major surgery or a significant injury within 4 weeks of starting treatment
- are taking part in another clinical trial. This is apart from an
observational study or if you are in follow up. - have any other medical condition, mental health condition or other circumstances that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic or sensitive to volrustomig or any of its ingredients
- have a
live vaccine within 30 days of starting treatment. You should not have a live vaccine during treatment or within 30 days after finishing treatment. You can have the COVID-19 and seasonal flu vaccines as they are not live vaccines. - are pregnant or breastfeeding. Or you plan to become pregnant or breastfeed during the trial.
Trial design
This is an international phase 3 trial. The team need up to 1,145 people worldwide to take part, including 58 from the UK.
Everyone has chemoradiotherapy as part of their standard care before they join this trial.
It is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor chooses which group you are in. The 2 groups are:
- volrustomig
- observation
Volrustomig
You have volrustomig as a drip into a vein. You have it once every 3 weeks. Each 3 week period is a . You can have up to 18 cycles of treatment (about 1 year) as long as it is helping and the side effects aren’t too bad.
You fill in questionnaires:
- before starting treatment
- at regular times during treatment
- when you finish treatment
- 30 days after finishing treatment
The questions ask about:
- your general health and wellbeing
- what daily activities you can do
- side effects and symptoms
These are quality of life questionnaires.
Observation
You will see the trial team regularly for up to a year. This is to see how you are and whether your cancer is coming back.
You fill in questionnaires:
- when you join the trial
- at regular times during observation
- at the end of observation
- 30 days after observation
The questions ask about:
- your general health and wellbeing
- what daily activities you can do
- symptoms
These are quality of life questionnaires.
Samples for research
Everyone
The team asks for a piece of previous cancer tissue sample () to do tests. If this is not available, then you have a new biopsy taken. This is to test for a protein called PD-L1.
They will also ask if you are willing to have a new biopsy taken if your cancer starts to grow again. You don’t have to agree to have this biopsy taken.
The team will ask for a blood sample when you join the trial. They will use this sample to look at your . You don’t have to agree to have this sample taken.
People having volrustomig
The team will ask you for extra blood samples. Where possible they will take these samples when you have blood tests as part of your routine care. They will use these samples to:
- find out how volrustomig affects the body
- find out what happens to volrustomig in the body
- look for substances (
biomarkers ) that might show how well treatment is working
Hospital visits
Everyone sees the doctor for a and tests before taking part. These tests include:
- blood tests
- a scan such as a CT scan, or an MRI scan and possibly a PET scan, your doctor will tell you which one you will have
- a heart trace (ECG)
- a heart scan which will be either an echo or a
MUGA
People having volrustomig
You see the doctor regularly during treatment. This is for tests and to see how you are.
Follow up
You see the doctor about a month after finishing treatment and then:
- at 2 months
- at 3 months
- every 3 months until the end of the study
Some of these visits will be in person at the clinic or as a phone call. Your doctor or a member of the trial team will tell you more about this.
People under observation
You see the doctor regularly for up to a year or until your cancer starts to grow again. This is to see how you are and for tests.
Follow up
After a year, or sooner if your cancer comes back, you see the doctor about a month later. Then you see them every 3 months until the end of the study.
These follow up visits will be by telephone where possible.
Scans
Everyone has a scan every:
- 3 months for the first year
- 2 months for the second year
- 6 months until your cancer starts to grow again
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
|
Volrustomig 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. |
Volrustomig is a new drug and there might be side effects we don’t know about.
The side effects we do know include:
- skin rash, itching or redness
- liver problems. This can cause yellowing of the eyes, dark urine, pale poo, feeling or being sick. You have regular blood tests to check that your liver is working ok.
- diarrhoea
- changes to how your
thyroid gland works
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 a high temperature (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. your body developing antibodies to volrustomig. This causes symptoms such as painful or aching joints, rash or fever and is part of a condition called immune complex disease.- your body releasing a large amount of a substance called cytokines. This is called cytokine release syndrome. It includes symptoms such as a high temperature, 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
Observation
The trial team do not anticipate any side effects if you are in this group.
Everyone
Your doctor will tell you about the possible side effects and answer any questions you might have, before you agree to take part in the trial.
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 Kevin Harrington
Supported by
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
