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Study of FOLFIRI with Domvanalimab and Zimberelimab in patients with advanced gastric or gastro-esophageal junction cancer who progressed after chemotherapy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating patients with advanced gastric cancer, gastro-esophageal junction adenocarcinoma, and esophageal cancer. The study compares two treatment approaches: a standard chemotherapy combination called FOLFIRI (which includes irinotecan, fluorouracil, and folinic acid) versus the same FOLFIRI chemotherapy plus two additional medications - domvanalimab and zimberelimab.

The purpose of this study is to determine if adding domvanalimab and zimberelimab to standard chemotherapy improves how long patients can live without their cancer getting worse. Domvanalimab and zimberelimab are types of immunotherapy medications that help the body's immune system fight cancer cells. The study is designed for patients whose cancer has continued to grow during or after receiving previous chemotherapy treatments.

The treatment will be given through intravenous infusion, which means the medications are delivered directly into the bloodstream through a vein. Patients will receive treatment for up to 24 months, with regular medical check-ups to monitor their health and assess how well the treatment is working. During the study, doctors will take images of the cancer using scans to measure any changes in tumor size.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    After joining the study, you will be randomly assigned to one of two treatment groups:

    Group 1: FOLFIRI treatment alone

    Group 2: FOLFIRI plus Domvanalimab and Zimberelimab

  2. Step 2

    Treatment administration

    Your treatment will be given through intravenous infusion (medication delivered directly into your vein)

    The FOLFIRI treatment consists of three medications: irinotecan, folinic acid, and fluorouracil

    If you are in group 2, you will also receive two additional medications: Domvanalimab and Zimberelimab

  3. Step 3

    Regular monitoring

    Your condition will be regularly monitored through CT scans or MRI to assess how the treatment is working

    Your doctor will check for any side effects during the entire treatment period

    Blood tests will be performed to monitor your organ function and overall health

  4. Step 4

    Quality of life assessment

    You will be asked to complete quality of life questionnaires at the following times:

    At the start of treatment

    After 3 months

    After 6 months

    After 12 months

  5. Step 5

    Safety monitoring

    Any side effects will be monitored and recorded throughout your treatment

    Safety monitoring will continue for 4 months after your last treatment

  6. Step 6

    Follow-up period

    After completing treatment, you will continue to be monitored to assess your long-term response

    Regular check-ups will be scheduled to track your progress

Who can join the trial?

16 criteria

  • Must be at least 18 years old
  • Must have a specific type of cancer: stomach cancer, cancer of the junction between stomach and esophagus, or esophageal adenocarcinoma that is advanced and cannot be surgically removed or has spread
  • Must have a HER2-negative tumor (HER2 is a protein that can affect cancer growth)
  • Must have had cancer progression during or within 6 months after receiving platinum-based treatment
  • Must be able to receive treatment with medications called irinotecan and 5-FU (types of chemotherapy drugs)
  • Must have at least one tumor that can be measured by CT scan or MRI
  • Must have good overall physical function (WHO performance status 0-1)
  • Must have adequate organ function as shown by blood tests, including:
    • Adequate blood cell counts
    • Proper liver function
    • Good kidney function
    • Sufficient albumin (a protein in blood)
    • If able to have children, must agree to use two forms of birth control during the study and for 6 months after the last treatment
    • Must be able to understand and sign an informed consent form
    • Must have social security coverage
    • Must provide a tumor sample for testing
    • Must agree to participate in all additional research studies

Who cannot join the trial?

13 criteria

  • History of autoimmune disease requiring systemic treatment within the past 2 years (condition where body's immune system attacks its own cells)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Previous treatment with immunotherapy (treatments that help your immune system fight cancer)
  • Significant heart disease or uncontrolled high blood pressure
  • Active infection requiring systemic therapy (medication that affects the whole body)
  • Known HIV infection or active hepatitis B or C
  • Other active cancers requiring treatment, except for certain skin cancers
  • Pregnancy or breastfeeding
  • Major surgery within 28 days before starting the study treatment
  • Participation in another clinical trial within 4 weeks before starting this study
  • Any condition that, in the opinion of the study doctor, would interfere with safe participation in the study
  • Unable to take oral medications
  • Known allergy or sensitivity to any of the study medications
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Investigated drugs

FOLFIRI is a combination chemotherapy treatment that includes three medications: fluorouracil, leucovorin, and irinotecan. It is commonly used to treat various types of gastrointestinal cancers. This combination works by interfering with cancer cell growth and division. Domvanalimab is an experimental immunotherapy medication that targets TIGIT, a protein found on immune cells. It works by helping the immune system recognize and fight cancer cells more effectively. Zimberelimab is an immunotherapy medication that blocks PD-1, a protein that can prevent T-cells (immune cells) from attacking cancer cells. By blocking PD-1, this medication helps the immune system to better recognize and destroy cancer cells. The combination of these medications is being studied to determine if adding immunotherapy (Domvanalimab and Zimberelimab) to standard chemotherapy (FOLFIRI) can improve outcomes for patients with advanced gastric or gastro-esophageal junction cancer.

What is already known about the treatment

  • Domvanalimab

    A novel immunotherapy medication administered intravenously that works by blocking TIGIT (T cell immunoreceptor with Ig and ITIM domains), currently being investigated in clinical trials for advanced gastric and gastro-oesophageal cancers. This antibody-based treatment enhances the immune system's ability to recognize and attack cancer cells by preventing immune suppression signals, working in combination with other cancer treatments. It belongs to the class of immune checkpoint inhibitors and is being studied alongside FOLFIRI chemotherapy and other immunotherapy agents to potentially improve outcomes in patients who have progressed after initial treatment.

  • Zimberelimab

    An immunotherapy drug administered through intravenous infusion that targets the PD-1 (Programmed Death-1) pathway, being studied in clinical trials for treating advanced gastric and gastro-oesophageal junction cancers. This monoclonal antibody works by blocking the PD-1 receptor on T cells, which helps restore the immune system's ability to detect and fight cancer cells. It belongs to the class of immune checkpoint inhibitors and is being evaluated in combination with FOLFIRI chemotherapy and other immunotherapy agents to potentially improve treatment outcomes in patients with advanced gastrointestinal cancers.

  • FOLFIRI

    A combination chemotherapy regimen administered intravenously that includes fluorouracil, leucovorin, and irinotecan, commonly used in treating various gastrointestinal cancers. This treatment works by interfering with cancer cell DNA replication and division, effectively slowing or stopping tumor growth. It belongs to the antineoplastic (chemotherapy) class of medications and is being studied both alone and in combination with immunotherapy drugs for patients with advanced gastric and gastro-oesophageal junction cancers.

Investigated diseases

  • Stomach cancer

    A disease that begins when cancer cells form in the inner lining of the stomach. The cancer typically develops slowly over many years, starting with pre-cancerous changes in the stomach lining. These abnormal cells can grow into the deeper layers of the stomach wall and eventually spread to other parts of the body.

  • Esophageal cancer

    A cancer that develops in the esophagus, the muscular tube that connects the throat to the stomach. The disease begins when cells in the inner layer of the esophagus start growing abnormally. These cells can gradually grow through the wall of the esophagus and spread to other parts of the body.

  • Gastro-esophageal junction adenocarcinoma

    A specific type of cancer that develops in the area where the esophagus joins the stomach. This cancer starts in the glandular cells at this junction point. The disease begins in the inner layer of this area and can grow outward through the other layers of tissue.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519258-35-00Protocol codePRODIGE 111Estimated enrolment95 patientsSponsorFondation Franc.Cancerologie Digestive

sourced from the EU Clinical Trials Register and site verification

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