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Study of Domvanalimab, Zimberelimab, and Chemotherapy for Patients with Advanced Esophageal or Gastric Cancer

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 is focused on studying treatments for people with certain types of cancer in the upper part of the digestive system, specifically gastric cancer, gastroesophageal junction cancer, and esophageal cancer. These cancers are either locally advanced, meaning they have grown but not spread to distant parts of the body, or metastatic, meaning they have spread to other areas. The study is testing a new combination of treatments that includes two experimental drugs, domvanalimab and zimberelimab, along with chemotherapy. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. This new combination will be compared to another treatment that uses the drug nivolumab with chemotherapy.

The purpose of the study is to see if the new combination of domvanalimab and zimberelimab with chemotherapy can help people live longer compared to the treatment with nivolumab and chemotherapy. Participants in the study will be randomly assigned to receive either the new combination treatment or the nivolumab treatment. The study will last for up to 24 months, during which participants will receive their assigned treatment and be monitored regularly by the study team. The study will also look at how the treatments affect the participants' quality of life and any side effects they may experience.

In addition to the main goal of comparing how long participants live with each treatment, the study will also look at other important factors. These include how long it takes for the cancer to start growing again, how many participants experience a reduction in their cancer size, and how long these reductions last. The study will also monitor any side effects or adverse events that participants may experience during the trial. This information will help researchers understand the safety and effectiveness of the new treatment combination.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and performance score.

    Informed consent is required, ensuring understanding of the study's requirements and restrictions.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: one receiving domvanalimab and zimberelimab with chemotherapy, and the other receiving nivolumab with chemotherapy.

  3. Step 3

    Treatment administration

    The treatment involves a combination of medications administered through different routes.

    Capecitabine is taken orally.

    Fluorouracil, nivolumab, zimberelimab, domvanalimab, and oxaliplatin are given as infusions.

    Calcium folinate is administered as an injection.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    Assessments include measuring the size of the cancer and checking for any progression or response.

  5. Step 5

    End of treatment

    The treatment continues until the study's end date or until the disease progresses or unacceptable side effects occur.

    The study aims to compare overall survival and other outcomes between the two treatment groups.

Who can join the trial?

5 criteria

  • Must be at least 18 years old at the time of signing the consent form.
  • Must be able to give signed consent, agreeing to the study's requirements and restrictions.
  • Must have a confirmed diagnosis of advanced or spread (metastatic) stomach, gastroesophageal junction (GEJ), or esophageal cancer. This means the cancer is either too advanced to be removed by surgery or has spread to other parts of the body.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. This score is a way to measure how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Must have at least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. This means there should be a tumor that can be measured to see if it changes in size during the study.

Who cannot join the trial?

6 criteria

  • Patients with other types of cancer besides **esophageal** or **gastric cancer** cannot participate.
  • Patients who have not been diagnosed with **metastatic esophageal or gastric cancer** are excluded. **Metastatic** means the cancer has spread to other parts of the body.
  • Patients who do not have high **PD-L1 expression** are excluded. **PD-L1** is a protein that can affect how the immune system fights cancer.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to receive the specific treatments being tested in the study are excluded.
  • Patients who are part of a vulnerable population, which may include those who cannot give informed consent, are excluded.
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Investigated drugs

  • Domvanalimab

    is an investigational medication being studied for its potential to help the immune system fight cancer. It is being tested in combination with other treatments to see if it can improve survival in patients with certain types of advanced stomach and esophageal cancers.

  • Zimberelimab

    is another investigational medication that is part of the trial. It is designed to work with the immune system to target and destroy cancer cells. Researchers are studying its effectiveness when used alongside other therapies in treating advanced cancers of the stomach and esophagus.

  • Nivolumab

    is a medication that helps the immune system recognize and attack cancer cells. It is already used in the treatment of various cancers and is being tested in this trial to see how well it works in combination with chemotherapy for patients with advanced stomach and esophageal cancers.

  • Chemotherapy

    refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used in combination with other medications to evaluate its effectiveness in treating advanced cancers of the stomach and esophagus.

What is already known about the treatment

  • Domvanalimab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating esophageal or gastric cancer, including metastatic forms. It is not yet widely used in standard medical practice but is gaining attention in medical literature. Domvanalimab is primarily indicated for patients with high PD-L1 expression in these cancers. It works by blocking specific proteins that inhibit the immune system, allowing the body to better target and destroy cancer cells. It is classified as an immune checkpoint inhibitor.

  • Zimberelimab

    Administered through intravenous infusion, zimberelimab is under investigation in clinical trials for treating esophageal or gastric cancer, particularly in advanced or metastatic stages. While not yet a standard treatment, it is being explored for its potential benefits in medical research. The main therapeutic use is for patients with high PD-L1 expression. Zimberelimab functions by targeting and inhibiting proteins that suppress the immune response, thereby enhancing the body's ability to fight cancer. It belongs to the class of immune checkpoint inhibitors.

  • Nivolumab

    This medication is given via intravenous infusion and is currently used in clinical settings for treating various cancers, including esophageal and gastric cancer. It is well-documented in medical literature and is approved for use in certain cancer treatments. Nivolumab is indicated for patients with advanced or metastatic cancer. It works by blocking proteins that prevent the immune system from attacking cancer cells, thus boosting the body's natural defenses. It is classified as an immune checkpoint inhibitor.

Investigated diseases

  • Esophageal Cancer

    This is a disease where malignant cells form in the tissues of the esophagus, the tube that carries food from the throat to the stomach. It often begins in the cells lining the inside of the esophagus and can grow to invade deeper layers and nearby structures. As it progresses, it may cause difficulty swallowing, weight loss, and chest pain. The cancer can spread to nearby lymph nodes and other parts of the body. Risk factors include smoking, heavy alcohol use, and certain dietary habits.

  • Gastric Cancer

    Also known as stomach cancer, this disease involves the growth of cancerous cells within the lining of the stomach. It typically starts in the mucus-producing cells on the stomach's inner surface and can develop into a tumor. As it advances, it may lead to symptoms like indigestion, stomach pain, nausea, and loss of appetite. The cancer can spread to nearby organs and lymph nodes. Factors such as infection with Helicobacter pylori, smoking, and certain dietary factors can increase the risk.

  • Metastatic Esophageal Cancer

    This condition occurs when esophageal cancer spreads beyond the esophagus to other parts of the body, such as the liver, lungs, or bones. The spread of cancer cells can lead to additional symptoms depending on the organs affected. It often results in more severe symptoms and complications compared to localized esophageal cancer. The progression involves the cancer cells traveling through the bloodstream or lymphatic system. This stage of cancer is more challenging to manage due to its widespread nature.

  • Metastatic Gastric Cancer

    This form of cancer arises when gastric cancer cells spread from the stomach to other areas of the body, such as the liver, lungs, or peritoneum. The spread can cause new symptoms related to the affected organs, in addition to those caused by the primary tumor. The cancer cells can travel through the blood or lymphatic system to distant sites. This stage indicates a more advanced progression of the disease, often leading to complex clinical scenarios.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507522-16-00Protocol codeSTAR-221Estimated enrolment715 patientsSponsorArcus Biosciences Inc.

sourced from the EU Clinical Trials Register and site verification

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