Local and systemic immune modulation by Rilvegostomig (AZD2936) in the treatment of advanced gastric cancer (RILVE Project)
Advanced stomach cancer can be difficult to treat, and doctors are looking for better ways to help the immune system recognise and attack cancer cells. This Phase II study, known as the RILVE Project, tests an experimental immunotherapy drug called rilvegostomig in adults newly diagnosed with advanced stomach cancer. Participants receive the study medicine through a drip. Doctors will take small tissue samples (biopsies) from the tumour and regular blood samples before and during treatment. This helps researchers see whether the drug encourages immune cells to move into the tumour and fight it. The trial also checks how safe the medicine is, what side effects occur, and whether it helps shrink tumours or stop them from growing. Taking part is voluntary, and participants are closely monitored by a specialist hospital team throughout the trial.
At a glance
What is this study about?
Stomach cancer, also known as gastric cancer, happens when abnormal cells in the stomach grow out of control. When it is advanced, it means the cancer has spread into deeper layers or nearby tissues and cannot be easily removed by surgery alone. Standard care often involves chemotherapy or immunotherapy, but researchers are searching for newer treatments that can work more effectively with the body's natural defences.
Rilvegostomig is an experimental immunotherapy medicine. Immunotherapies are designed to take the 'brakes' off your body's immune system, allowing your white blood cells to locate and destroy cancer cells. In this trial, doctors are looking at what happens inside the tumour when a patient receives rilvegostomig, either on its own or alongside an established immunotherapy called pembrolizumab (Keytruda).
To understand how the drug works, doctors will look closely at tumour samples taken before and shortly after starting treatment. This gives scientists a direct look at whether helpful immune cells are moving into the tumour to attack it. They will also measure substances in the blood to track how the wider immune system responds.
Studies like this are crucial because they help doctors find out not only if a drug works, but exactly how it works inside the human body. The findings could guide future cancer care and help doctors choose the most effective treatments for patients in the future.
Key takeaways
- Tests an experimental immunotherapy drug called rilvegostomig for advanced stomach cancer.
- Open to adults aged 18 and over who have not yet had treatment for their advanced cancer.
- Aims to see how the medicine wakes up the immune system to fight tumour cells.
- Involves tumour biopsies, blood tests, and scans to track your body's response.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is for adults aged 18 and older who have been diagnosed with advanced stomach (gastric) cancer.
To take part, you must not have received prior drug treatments, such as chemotherapy or immunotherapy, for your advanced cancer. Doctors call this being 'treatment-naïve'.
You must also be well enough to undergo study procedures, which include having small tissue samples (biopsies) taken from your tumour and attending regular hospital visits for treatment and monitoring. Your hospital team will carry out health checks to confirm whether the trial is safe and suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with advanced stomach (gastric) cancer.
- I have not yet started medical treatment for my advanced stomach cancer.
- I am able and willing to attend regular hospital appointments.
- I am willing to have tumour biopsies and blood tests taken as part of the study.
What does participation involve?
If you decide to take part, you will visit a hospital cancer clinic regularly. The study medicine is given through a small tube into a vein (an intravenous infusion or drip). Before starting and shortly after your first doses, you will have a small procedure called a biopsy, where a doctor takes a tiny sample of tumour tissue to see how the immune cells are reacting. Throughout the trial, you will have regular safety checks, including blood tests, physical examinations, and scans (such as CT scans) to check if your tumour is shrinking or staying stable. The study team will follow your progress closely during treatment and for a period afterwards to monitor your health and recovery.
Potential risks and benefits
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Common questions
What is rilvegostomig?
Rilvegostomig is an experimental drug designed to help your own immune system recognise and attack cancer cells more effectively.
What does 'treatment-naïve' mean?
It means you have not yet received medical treatment, such as chemotherapy or immunotherapy, for your advanced stomach cancer.
Why do I need to have biopsies?
A biopsy allows doctors to examine a tiny piece of your tumour under a microscope. This shows whether the drug is helping immune cells travel into the tumour to fight it.
Can I leave the study if I change my mind?
Yes. You are free to leave the trial at any time, for any reason. Your regular doctors will continue to give you the best available standard care.
Will taking part cost me anything?
No. The study medicines and tests are provided free of charge, and you will continue to receive care through the healthcare system.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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