RecruitingPHASE2INTERVENTIONAL

Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer

This study is looking at new treatments for a type of stomach or gullet (gastroesophageal junction) cancer. We're focusing on cancers that have a specific genetic change called 'MMRd' or 'MSI-H'. The study is testing two drugs, zimberelimab and domvanalimab, either alone or in combination. These drugs are a type of immunotherapy, which helps your body's own immune system fight cancer. The main goal is to see if these treatments can shrink the cancer significantly before surgery. This might mean patients need less chemotherapy, or even avoid it altogether. We'll also be checking how safe the treatments are and how well patients recover after surgery.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

Start

20 Feb 2025

Estimated completion

01 Sep 2031

Locally Advanced Gastric Adenocarcinoma MSI-H/dMMR Gastric Cancer MSI-H/dMMR Gastroesophageal-junction Cancer

What is this study about?

This research study is about finding better ways to treat a specific type of stomach cancer, or cancer where the gullet joins the stomach. These cancers are special because they have a genetic signature called 'MMRd' or 'MSI-H', which means they might respond well to a type of treatment called immunotherapy. Immunotherapy works by boosting your body's natural defences to recognise and fight cancer cells.

The study is investigating two immunotherapy drugs: zimberelimab and domvanalimab. Zimberelimab is already known to help the immune system. Domvanalimab is another drug that could make zimberelimab even more effective. We want to see if using zimberelimab alone, or زمبرليماب with domvanalimab, can shrink the cancer significantly before surgery. This is important because if the cancer shrinks a lot, it might make surgery easier and could potentially mean patients don't need to go through as much strong chemotherapy, or perhaps none at all.

The main question we're trying to answer is how well these treatments work by looking at the cancer tissue after surgery to see how much it has responded. We'll also be carefully checking for any side effects and how patients feel during and after treatment. By understanding which treatment works best, we hope to improve the outlook for people with this type of cancer.

Key takeaways

This study is for specific types of stomach or gullet cancer.
It uses new immune-boosting drugs (immunotherapy) before surgery.
The main goal is to shrink your cancer more effectively and safely.
It could potentially reduce or replace the need for strong chemotherapy.
Your health would be closely monitored throughout the study.
It's a way to explore advanced treatments for your cancer.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have a confirmed diagnosis of stomach cancer or cancer where the gullet meets the stomach. Importantly, your cancer must show specific genetic markers known as 'MMRd' or 'MSI-H'. This is usually checked by special tests on your cancer tissue.

Your cancer must not have spread to distant parts of your body, meaning it's still considered treatable with surgery. A team of doctors will need to agree that surgery is a good option for you after potential treatment, and that your cancer can likely be completely removed. You also can't have received any previous treatment for this specific cancer.

Finally, your general health needs to be good enough to take part. This includes having good blood test results for your blood count, kidney function, and liver function. You'll also need to be able to comfortably carry out most of your daily activities.

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 18 years old or older.
I have stomach or gullet cancer that has 'MMRd' or 'MSI-H' features.
My cancer has not spread to distant parts of my body.
Doctors believe my cancer can be removed with surgery.
I haven't had previous cancer treatment for this specific cancer.
My general health, including blood tests, is good enough for me to take part.

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given one of the study drugs, either zimberelimab on its own or zimberelimab combined with domvanalimab. These drugs are usually given through a drip (infusion) into a vein. You would have regular hospital visits for these treatments and check-ups.

Before, during, and after your treatment, you will have various tests. These include blood tests to check your general health and how your body is reacting to the treatment, and scans (like CT or PET scans) to see how the cancer is responding. You will also have surgery as planned. Doctors will then closely monitor your recovery and progress for some time after your surgery. The full duration of your participation, including follow-up, will be discussed in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available. Your health will be closely monitored, and your participation helps advance medical knowledge for others. However, there are potential risks, as these are new treatments and might have side effects that are not yet fully known. While all care is taken, sometimes treatments may not work as expected or might cause unexpected reactions. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Addenbrooke's Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting
Royal Devon University Healthcare Foundation Trust
Verified postcode
Exeter, United Kingdom· Recruiting
Ninewells hospital and Medical School
Verified postcode
Dundee, United Kingdom· Recruiting
Kent & Canterbury Hospital
Verified postcode
Canterbury, United Kingdom· Recruiting
Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
The Royal Marsden NHSFT
Verified postcode
London, United Kingdom· Recruiting
St James's University hospital
Verified postcode
Leeds, United Kingdom· Recruiting
St Bartholomew's Hospital
Verified postcode
London, United Kingdom· Recruiting
University College London Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'MMRd' or 'MSI-H' cancer?

These are genetic changes in your cancer cells that mean they might respond better to certain new treatments, specifically immunotherapies.

What are zimberelimab and domvanalimab?

They are types of immunotherapy drugs. Immunotherapy uses your body's own immune system to fight cancer cells.

Why are these drugs given before surgery?

Giving the drugs before surgery aims to shrink the tumour as much as possible, which might make the surgery more successful or reduce the need for strong chemotherapy.

Will I still need chemotherapy?

One of the goals of this study is to see if these treatments can reduce or even remove the need for chemotherapy, but this is what the study is trying to find out.

How will my health be checked during the study?

You'll have regular blood tests, scans, and doctor's appointments to monitor your cancer and your general health.

How to find out more

Project Manager

zodiac@rmh.nhs.uk 02086613279 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.