Recruiting

Study Comparing Survival in Patients with Advanced or Metastatic Gastric Cancer Treated with Botensilimab and Balstilimab vs. Standard Drug Combination

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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 cancer known as locally advanced or metastatic MSI/dMMR esogastric adenocarcinoma. This is a form of stomach cancer that has specific genetic characteristics, making it more challenging to treat. The study aims to compare the effectiveness of a new combination of treatments against the current standard treatment. The new treatment involves two drugs called botensilimab and balstilimab, which are types of immune checkpoint inhibitors. These drugs work by helping the immune system recognize and attack cancer cells. The standard treatment being compared includes a combination of chemotherapy drugs known as FOLFOX or XELOX, along with another immune therapy drug called nivolumab.

The purpose of this study is to see which treatment option helps patients live longer. Participants in the study will be randomly assigned to receive either the new combination of botensilimab and balstilimab or the standard treatment with FOLFOX/XELOX and nivolumab. The study will last for a period of up to 24 months, during which patients will receive their assigned treatment and be monitored regularly. The treatments are given through an IV infusion, which means they are administered directly into the bloodstream through a vein. Some patients may also receive a placebo, which is a substance with no active drug, to help compare the effects of the treatments more accurately.

Throughout the study, doctors will closely monitor the patients' health and any side effects they may experience. The main goal is to determine which treatment is more effective in improving the overall survival of patients with this type of cancer. The study will also look at other factors, such as the quality of life of the patients and how their cancer responds to the treatment over time. This research is important for finding better ways to treat this challenging form of cancer and potentially improving outcomes for patients in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will begin the treatment process for locally advanced or metastatic MSI/dMMR esogastric adenocarcinomas.
The study aims to compare the effectiveness of a combination of immune checkpoint inhibitors (botensilimab + balstilimab) with the standard treatment (FOLFOX/XELOX + nivolumab).
Step 2
Treatment phase
The patient will receive medications through intravenous infusion and oral administration.
The standard treatment includes oxaliplatin and fluorouracil administered via intravenous infusion, and capecitabine taken orally.
The immune checkpoint inhibitors, botensilimab and balstilimab, are also administered through intravenous infusion.
Step 3
Monitoring and assessments
Throughout the trial, the patient's health and response to treatment will be closely monitored.
Regular assessments will be conducted to evaluate the overall survival, progression-free survival, and objective response rate after 16 weeks of treatment.
The patient's quality of life will be assessed using specific questionnaires.
Step 4
End of treatment
The treatment phase will continue until the study's completion or until the patient is advised to stop due to health reasons.
The estimated end date for the trial is January 15, 2028.

Who can join the trial?

13 criteria

Must be a male or female patient who is at least 18 years old at the time of signing the consent form.
Women who can have children must have a negative pregnancy test before starting the study and agree to use very effective birth control methods during the study and for a certain time after treatment ends.
Men with female partners who can have children must agree to use very effective birth control methods during the study and for a certain time after treatment ends. If their partner is pregnant, they must use a condom.
Must understand, sign, and date the consent form before any study-specific procedures are done and be willing to follow the study visits and procedures.
Must have medical insurance coverage.
Must have a specific type of advanced or metastatic stomach cancer that is HER2 negative and shows certain characteristics (MSI-H/dMMR and PD-L1 with a combined positive score of 5 or more).
Must be receiving first-line therapy for advanced or metastatic disease.
Must not have had chemotherapy for advanced or metastatic disease before. Previous chemotherapy is allowed if it was completed at least 6 months before the cancer returned.
Must have a measurable disease, meaning at least one tumor that can be accurately measured by a CT scan.
Must have a performance status of 0 or 1 on the ECOG scale, which measures how well a patient can perform daily activities.
Must have adequate blood and organ function as shown by specific lab test results.
Must have a sample of the tumor tissue available for testing, which meets certain quality and quantity criteria.
Must have a tumor that can be seen by medical imaging and is accessible for repeatable sampling with a needle, allowing for at least 4 samples to be taken safely.

Who cannot join the trial?

3 criteria

Patients who do not have **locally advanced/metastatic, MSI-H/dMMR gastric cancer**. This means the cancer has not spread to nearby or distant parts of the body and does not have specific genetic features known as MSI-H or dMMR.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centr Georges Francois Leclerc
Verified
Dijon, France
Centre Francois Baclesse
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Caen, France
Centre Hospitalier Regional Et Universitaire De Brest
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Brest, France

Trial locations

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Investigated drugs

Botensilimab
is an immune checkpoint inhibitor used in this trial. It works by helping the immune system recognize and attack cancer cells more effectively. This medication is part of the experimental treatment being tested for its potential to improve survival in patients with certain types of advanced esogastric cancer.
Balstilimab
is another immune checkpoint inhibitor included in the trial. Similar to botensilimab, it aims to enhance the body's immune response against cancer cells. When used in combination with botensilimab, it is hoped to provide a more effective treatment option for patients.
FOLFOX
is a standard chemotherapy regimen that combines several drugs to treat cancer. It includes a mix of medications that work together to stop the growth of cancer cells. This regimen is part of the standard care being compared in the trial.
XELOX
is another standard chemotherapy regimen used in the treatment of cancer. Like FOLFOX, it combines different drugs to target and kill cancer cells. It is also part of the standard care in this study.
Nivolumab
is an immune checkpoint inhibitor that is part of the standard treatment in this trial. It helps the immune system to better detect and fight cancer cells, and is used in combination with chemotherapy regimens like FOLFOX or XELOX.

What is already known about the treatment

Botensilimab
Botensilimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating locally advanced or metastatic MSI-H/dMMR gastric cancer. It is an immune checkpoint inhibitor, which means it helps the immune system recognize and attack cancer cells more effectively. By blocking certain proteins that prevent immune cells from attacking cancer, Botensilimab enhances the body's natural defense against tumors. It is classified as an immunotherapy agent.
Balstilimab
Balstilimab is also administered intravenously and is under investigation in clinical trials for its role in treating locally advanced or metastatic MSI-H/dMMR gastric cancer. Like Botensilimab, it is an immune checkpoint inhibitor that works by blocking proteins that inhibit the immune response against cancer cells, thereby boosting the immune system's ability to fight cancer. It falls under the category of immunotherapy drugs.

Investigated diseases

Gastric Cancer – Gastric cancer, also known as stomach cancer, begins in the cells lining the stomach. It often starts in the mucus-producing cells on the stomach's inner surface. As the disease progresses, it can invade deeper layers of the stomach wall and spread to nearby organs. Symptoms may include indigestion, stomach pain, nausea, and weight loss. The disease can spread to lymph nodes and other parts of the body, such as the liver and lungs. The progression can vary, with some cases remaining localized while others become more widespread.