Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PRODIGE 111 – DOMZIGAST A randomized phase II study evaluating FOLFIRI vs FOLFIRI plus Domvanalimab (anti-TIGIT) and Zimberelimab (anti-PD1) in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma with progression during or after peri-operative chemotherapy.

This study, called PRODIGE 111 – DOMZIGAST, is for people with advanced stomach cancer or cancer where the food pipe meets the stomach. This is for cancers that have continued to grow during or after previous chemotherapy treatments. We want to see if a combination of treatments works better than standard chemotherapy alone. The standard treatment is called FOLFIRI, which combines three drugs: Irinotecan, Folinic Acid, and Fluorouracil. In this study, we're comparing FOLFIRI with FOLFIRI plus two new drugs, domvanalimab and zimberelimab. These new drugs are designed to help your body's immune system fight the cancer. We're especially interested in how many patients are alive and their cancer hasn't gotten worse after six months.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondation Franc.Cancerologie Digestive

Enrolment target

Start

08 Oct 2025

stomach cancer Esophage gastro-oesophageal junction adenocarcinoma

What is this study about?

This study is called PRODIGE 111 – DOMZIGAST and it's looking into new ways to treat advanced stomach cancer, or cancer that's found where your food pipe joins your stomach. This type of cancer is considered 'advanced' if it has spread or can't be removed with surgery, and it has started to grow again even after you've had chemotherapy before surgery or to treat the cancer. The main goal of this study is to see if adding two new drugs, domvanalimab and zimberelimab, to a standard chemotherapy treatment called FOLFIRI, can help people live longer without their cancer getting worse.

FOLFIRI is a common chemotherapy treatment that uses three different medicines: Irinotecan, Folinic Acid, and Fluorouracil. The new drugs, domvanalimab and zimberelimab, work by helping your body's own immune system to recognise and fight the cancer cells. This is a Phase II study, which means it’s an early stage of testing new treatments. We want to find out if these new drugs are safe and effective enough to be tested in larger studies later on.

The researchers will be carefully checking how patients respond to these treatments. They'll look at things like how many patients are alive and their cancer hasn't progressed after six months, how long patients live overall, and how much the tumours shrink. They will also keep a close eye on any side effects and how the treatments affect patients' quality of life, which is how well they feel and are able to do daily activities.

Key takeaways

This study evaluates new treatments for advanced stomach or gastro-oesophageal junction cancer.
It compares standard chemotherapy (FOLFIRI) with FOLFIRI plus two new immune system-boosting drugs.
The main aim is to see if the new drugs help patients live longer without their cancer progressing.
It's a Phase II study, so it's an early stage of testing for safety and effectiveness.
Participation involves regular hospital visits for treatment, tests, and scans.

Who may be eligible?

To join this study, you must be 18 years old or older. The study is open to both men and women.

Only people with advanced stomach cancer or cancer where the food pipe meets the stomach can take part. This means your cancer must have come back or gotten worse despite having had chemotherapy around the time of surgery or as a main treatment before.

The doctors will check other health details to make sure the treatment is safe for you. This might include checking your general health, organ function, and making sure you don't have certain other health conditions that could make the treatment risky. You'll need to discuss all your medical history with the study team to see if you meet all the requirements.

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.

Are you 18 years old or older?
Do you have advanced stomach cancer or cancer where your food pipe meets your stomach?
Has your cancer grown or returned despite previous chemotherapy treatments?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two treatment groups – like flipping a coin, but done by a computer. You'll either receive the standard FOLFIRI chemotherapy, or FOLFIRI plus the two new drugs, domvanalimab and zimberelimab. Both treatments will be given through a drip (intravenous infusion) at the hospital.

You will have regular hospital visits, likely every few weeks, to receive your treatment and have health checks. These checks will include blood tests, physical exams, and regular scans (like CT scans) to see how your cancer is responding and to monitor for any side effects. These scans are important for checking if the cancer is growing, shrinking, or staying the same.

The study will continue as long as your cancer doesn't get worse, or until you experience side effects that make it not possible to continue. After you stop treatment, you'll have follow-up appointments to monitor your health and how you're feeling. The total time you'd be involved in the study, including treatment and follow-up, can vary for each person.

Potential risks and benefits

Taking part in a study like this might offer a chance to try new treatments that aren't yet widely available, which could potentially help control your cancer. However, there's no guarantee the new drugs will work for everyone, or that they will be better than the standard treatment. As with all medical treatments, there are potential risks and side effects. For example, chemotherapy and the new drugs can cause various side effects, which the study team will explain in detail. Your safety is very important, and you will be closely monitored. Remember, participating is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

—
Unverified
France

Common questions

What is FOLFIRI?

FOLFIRI is a common chemotherapy treatment that uses a combination of three different medicines: Irinotecan, Folinic Acid, and Fluorouracil. It's often used to treat various types of cancer.

What are domvanalimab and zimberelimab?

These are two new drugs being tested. They are designed to help your body's immune system fight the cancer cells by targeting specific proteins.

What does 'advanced' cancer mean in this study?

In this study, 'advanced' means that the cancer has either spread or has grown despite you having had chemotherapy treatment before.

What is the main goal of the study?

The main goal is to see if adding the new drugs (domvanalimab and zimberelimab) to FOLFIRI chemotherapy helps people live longer without their cancer getting worse after six months.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of the two treatment groups by computer, so neither you nor the study team will know which specific treatment you are receiving until after the study is complete, unless there's a medical reason to find out sooner.