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Study on EXL01 with Nivolumab and FOLFOX for First-Line Treatment in Patients with PD-L1 CPS ≥5 Metastatic 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 a type of stomach cancer known as metastatic gastric cancer. The study is exploring a new treatment approach that combines several medications. The main treatment being tested is a gut microbiome intervention with a product called EXL01, which is a live biotherapeutic product. This is being used alongside other medications, including nivolumab, a type of immunotherapy, and a chemotherapy regimen known as FOLFOX. FOLFOX includes the drugs oxaliplatin, fluorouracil sodium, and calcium folinate. The purpose of the study is to assess how well this combination works as a first-line treatment for patients with a specific type of advanced gastric cancer that shows a high level of a protein called PD-L1.

Participants in the study will receive the treatment over a period of up to 24 months. The study will monitor the response of the cancer to the treatment at various points, with a key focus on the response rate at four months. The study will also look at the safety of the treatment and how it affects the gut microbiota, which is the community of microorganisms living in the digestive tract. The trial will include regular check-ups and assessments to track the progress and any side effects experienced by the participants.

This study is part of a larger effort to find more effective treatments for metastatic gastric cancer, particularly for patients whose cancer cells express a high level of PD-L1. By combining different types of therapies, the study aims to improve outcomes for patients with this challenging condition. The trial is being conducted in a structured and monitored environment to ensure the safety and well-being of all participants.

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, the patient must have signed a written informed consent form. This is necessary before any study-related procedures begin.

    A tumor tissue sample must be provided for research purposes. This sample can be from the primary or metastatic site and must be submitted to a central laboratory.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of medications: EXL01, nivolumab, and FOLFOX. FOLFOX is a combination of oxaliplatin and fluorouracil sodium.

    EXL01 is administered orally in the form of capsules.

    Nivolumab is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

    Oxaliplatin and fluorouracil sodium are also administered intravenously as part of the FOLFOX regimen.

  3. Step 3

    Treatment schedule

    The treatment is scheduled to be administered in cycles. Each cycle typically lasts for a few weeks, with specific days allocated for medication administration.

    The exact dosage and frequency of each medication will be determined by the healthcare team based on individual patient needs and responses.

  4. Step 4

    Monitoring and assessments

    Regular monitoring and assessments are conducted to evaluate the patient's response to the treatment. This includes imaging tests like CT scans or MRIs to measure tumor size.

    Blood tests and other laboratory evaluations are performed to monitor health and detect any side effects.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation is conducted to assess the overall response to the therapy.

    The primary goal is to determine the objective response rate at 4 months, which measures how well the cancer has responded to the treatment.

Who can join the trial?

15 criteria

  • Patients must have signed a written consent form before any study-related procedures that are not part of normal care.
  • A sample of the tumor tissue must be available for research purposes. This can be a tissue block or slides from the primary or metastatic site.
  • Patients must be registered in a national health care system.
  • Patients must be at least 18 years old.
  • Women must not be pregnant, breastfeeding, or planning to become pregnant during the study.
  • Women who can have children must have a negative pregnancy test before starting the study and agree to use birth control during the study and for a certain time after the last dose of the study drug.
  • Men who are fertile and sexually active with women who can have children must agree to use birth control during the study and for a certain time after the last dose of the study drug. They must also agree not to donate sperm during this time.
  • Patients must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests.
  • Patients must have advanced or metastatic gastric cancer or cancer at the junction of the stomach and esophagus, confirmed as adenocarcinoma.
  • The cancer must show a certain level of a protein called PD-L1.
  • Patients must not have received prior cancer treatment for advanced or metastatic disease, except for certain types of therapy completed at least 6 months before the diagnosis of metastatic disease.
  • Patients must have at least one measurable tumor that can be assessed by a CT scan or MRI and be able to undergo repeated imaging tests.
  • Patients must have a performance status of 0 or 1, which means they are fully active or have some restrictions but can still carry out light work.
  • Patients must have adequate blood and organ function based on recent laboratory tests.
  • The QT interval, a measure of heart rhythm, must be within a certain range: 450 milliseconds or less for males and 470 milliseconds or less for females.

Who cannot join the trial?

10 criteria

  • Patients who have had another type of cancer in the past, unless it was a type that is not expected to come back.
  • Patients who have serious heart problems, like heart failure or a recent heart attack.
  • Patients who have uncontrolled high blood pressure, which means their blood pressure is not well managed with medication.
  • Patients who have an active infection that needs treatment with antibiotics.
  • Patients who have a known allergy to any of the drugs being used in the study.
  • Patients who are pregnant or breastfeeding, as the study drugs might affect the baby.
  • Patients who have a condition called autoimmune disease, where the body's immune system attacks its own healthy cells.
  • Patients who have had a major surgery within the last 4 weeks before joining the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse that could interfere with their ability to follow the study procedures.
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Investigated drugs

  • EXL01

    is a treatment designed to interact with the gut microbiome. It is being studied to see if it can help improve the effectiveness of cancer treatments in patients with advanced gastric cancer.

  • Nivolumab

    is a type of immunotherapy. It works by helping the immune system recognize and attack cancer cells more effectively. It is used in this trial to treat patients with advanced gastric cancer.

  • FOLFOX

    is a combination of chemotherapy drugs. It includes medications that work together to stop the growth of cancer cells. This combination is used in the trial to treat patients with advanced gastric cancer.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion. It is currently approved and widely used in the treatment of various cancers, including metastatic gastric adenocarcinoma. The main therapeutic indication for nivolumab in this context is to enhance the immune system's ability to fight cancer cells. At the molecular level, nivolumab works by blocking the PD-1 protein on immune cells, preventing cancer cells from evading the immune response. It is classified as an immune checkpoint inhibitor.

  • FOLFOX

    FOLFOX is a chemotherapy regimen that is administered intravenously. It is a well-established treatment in oncology, particularly for colorectal and gastric cancers. The main therapeutic indication is to kill rapidly dividing cancer cells. FOLFOX works by interfering with DNA replication and cell division, primarily through the action of its components, which include folinic acid, fluorouracil, and oxaliplatin. It is classified as a combination chemotherapy regimen.

  • EXL01

    EXL01 is administered orally as part of a gut microbiome intervention. It is currently being studied in clinical trials for its potential role in enhancing cancer treatment outcomes. The main therapeutic indication is to modulate the gut microbiome to improve the effectiveness of cancer therapies. The mechanism of action involves altering the composition of gut bacteria to support immune function and enhance the response to cancer treatment. It is classified as a microbiome therapeutic agent.

Investigated diseases

Metastatic Gastric Adenocarcinoma – This is a type of stomach cancer that has spread beyond the stomach to other parts of the body. It originates in the glandular cells of the stomach lining, which produce mucus and other fluids. As the disease progresses, cancer cells can invade nearby tissues and organs, such as the liver, lungs, and lymph nodes. The spread of cancer cells occurs through the bloodstream or lymphatic system. Symptoms may include weight loss, stomach pain, nausea, and difficulty swallowing. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower progression.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506753-38-00Protocol codeBIG G-122Estimated enrolment120 patientsSponsorAssociation Gercor

sourced from the EU Clinical Trials Register and site verification

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