A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma
This study is testing a new treatment approach for people newly diagnosed with advanced or spreading (metastatic) cancer of the stomach or food pipe (oesophagus). Standard treatment often includes chemotherapy paired with an immunotherapy drug called nivolumab, which helps the body's immune system fight cancer cells. In this trial, researchers are comparing this standard treatment against a new combination. The new group receives chemotherapy plus two different immunotherapy medicines: domvanalimab and zimberelimab. Doctors want to see if combining these two newer drugs can target cancer cells more effectively, slow down tumour growth, and help patients live longer with a good quality of life. Participants will be placed into one of the two treatment groups by chance. Doctors will closely track how the cancer responds, manage any side effects, and monitor general well-being throughout the study.
At a glance
What is this study about?
Cancers of the stomach and the food pipe (the oesophagus) can be challenging to treat, especially when they are diagnosed at an advanced stage or have spread to other parts of the body. In these situations, surgery is usually not possible, and doctors rely on medicines to control the disease, ease symptoms, and help people live longer.
Currently, many patients receive chemotherapy alongside an immunotherapy medicine called nivolumab. Immunotherapy works by 'taking the brakes off' the body's natural defence system, allowing it to recognise and destroy cancer cells. While this standard treatment helps many people, doctors are constantly searching for ways to make it work even better and for longer periods.
This trial investigates whether adding two newer immunotherapy drugs—domvanalimab and zimberelimab—to standard chemotherapy works better than the current standard care. These two medicines work together in different ways to boost the immune response against the tumour. By comparing the two approaches directly, researchers hope to confirm whether this new combination improves survival and preserves daily quality of life.
Key takeaways
- A phase 3 trial comparing a new immunotherapy duo against the current standard immunotherapy, both given with chemotherapy.
- Aimed at adults newly diagnosed with advanced or metastatic stomach or food pipe cancer.
- The primary goal is to find out if the new combination helps patients live longer.
- Treatment is allocated by chance and given via regular hospital drips.
- Participation is entirely voluntary, with close health monitoring throughout.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with advanced adenocarcinoma of the stomach, the food pipe, or the junction where the two meet. 'Advanced' means the cancer cannot be completely removed with surgery or has spread to other areas of the body.
To take part, people must not have received previous drug treatment, such as chemotherapy or immunotherapy, for their advanced cancer. Participants also need to be reasonably active and well enough to attend hospital appointments and undergo regular assessments.
People with certain other serious medical conditions, such as active autoimmune diseases or severe heart problems, may not be able to join. Your hospital doctor or oncologist can check your medical records and scans to see if this study is 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 cancer of the stomach or food pipe (oesophagus).
- My cancer cannot be removed by surgery or has spread to other parts of the body.
- I have not yet started drug treatment (chemotherapy or immunotherapy) for this advanced stage.
- I am well enough to attend regular hospital visits for treatment and scans.
What does participation involve?
If you decide to take part, a computer will place you into one of two groups by chance. One group receives the current standard care (nivolumab and chemotherapy), while the other group receives the new combination (domvanalimab, zimberelimab, and chemotherapy). Both treatments are given through a drip into a vein at regular hospital visits, usually every two to three weeks.
During your visits, your healthcare team will check your blood, monitor your general health, and ask you about any symptoms or side effects. You will have regular CT or MRI scans, usually every few weeks or months, to see how your tumour is responding to the medicine.
You will continue to receive the study treatment for as long as it is helping you and the side effects remain manageable. If you stop the treatment, the study team will continue to check in on you periodically to see how you are doing.
Potential risks and benefits
Locations (9)
- —UnverifiedHungary
- —UnverifiedLithuania
- —UnverifiedItaly
- —UnverifiedPortugal
- —UnverifiedRomania
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedGreece
Common questions
What is immunotherapy?
Immunotherapy is a type of cancer treatment that helps your body's own immune system recognise and attack cancer cells.
Can I choose which treatment group I am in?
No. A computer assigns you to a group by chance. This process, called randomisation, ensures the comparison between the two treatments is fair and scientifically accurate.
Will I have to pay for the trial medicines?
No. All trial medicines and any extra study tests are provided free of charge.
What happens if the treatment stops working?
Your doctor will monitor your scans closely. If the cancer grows or if side effects become too difficult, the study treatment will stop, and your doctor will discuss other available care options with you.
Can I leave the trial if I change my mind?
Yes, you can leave the study at any point. You do not need to give a reason, and choosing to leave will not affect your relationship with your medical team or your standard care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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