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Study of Tremelimumab and Durvalumab for Patients with Resectable Stomach or Gastroesophageal Junction Cancer with Microsatellite Instability

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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 that affects the stomach or the area where the stomach meets the esophagus. This cancer is characterized by a specific genetic feature called microsatellite instability and does not involve infection with the Epstein-Barr virus. The study is investigating the use of two medications, Durvalumab and Tremelimumab, which are types of immunotherapy. Immunotherapy is a treatment that helps the body's immune system fight cancer.

The purpose of the study is to evaluate how effective the combination of Durvalumab and Tremelimumab is when used before surgery or as a definitive treatment for this type of cancer. The study is divided into two groups: one group will receive the treatment before surgery, and the other group will receive it as their main treatment without surgery. Participants will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein.

The study will monitor participants over a period of time to see how well the cancer responds to the treatment. Researchers will look at various outcomes, such as whether the cancer disappears completely, how long participants live without the cancer coming back, and overall survival rates. The study aims to provide valuable information on the potential benefits of using these immunotherapy drugs for treating this specific type of stomach cancer.

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
Initial treatment phase
The treatment involves the administration of two immunotherapy medications: durvalumab and tremelimumab. These medications are given through an intravenous route, which means they are delivered directly into the bloodstream through a vein.
The purpose of this phase is to assess the activity of the combination of these medications as a treatment for resectable gastric or gastroesophageal junction cancer with microsatellite instability.
Step 2
Treatment administration
The medications are administered according to a specific schedule. The exact dosage and frequency of administration will be determined by the medical team based on individual patient needs and the study protocol.
This phase is crucial for evaluating the effectiveness of the treatment in reducing or eliminating cancer cells before any surgical intervention.
Step 3
Monitoring and evaluation
Regular monitoring is conducted to assess the response to the treatment. This includes various tests and imaging studies to evaluate the size and spread of the cancer.
The primary goal is to achieve a complete response, meaning no detectable cancer remains, as assessed by radiological examinations and biopsies.
Step 4
Follow-up phase
After the initial treatment phase, ongoing follow-up is necessary to monitor for any signs of cancer recurrence or progression.
This phase includes regular check-ups and tests to ensure the cancer has not returned and to evaluate overall health and well-being.

Who can join the trial?

10 criteria

The patient must provide written informed consent, which means they agree to participate in the study after understanding all the details.
The patient must be at least 18 years old.
The patient should have an ECOG Performance Status of 0-1, which indicates they are fully active or have some symptoms but can still carry out light work.
The patient must weigh more than 30 kg.
The patient must have a diagnosis of resectable gastric or gastroesophageal junction cancer, which means the cancer can be surgically removed.
The patient should not have distant metastases, meaning the cancer has not spread to other organs, as confirmed by specific imaging tests.
The patient should have a life expectancy of at least 12 weeks.
The patient must have MSI-high status confirmed by specific tests, and the cancer should be EBV-negative.
The patient must have adequate bone marrow and organ function, as shown by certain blood tests.
The patient must be able to access treatment and follow-up at the participating center.

Who cannot join the trial?

4 criteria

Patients with **cancer** that has spread to other organs cannot participate. **Cancer** is a disease where cells in the body grow uncontrollably.
Patients whose cancer cannot be surgically removed are not eligible. **Surgically resectable** means the cancer can be removed by surgery.
Patients with cancer that does not show **microsatellite instability** are excluded. **Microsatellite instability** is a condition where the DNA in cancer cells has a lot of changes.
Patients with cancer that has **EBV infection** are not allowed. **EBV infection** refers to the presence of a virus called Epstein-Barr virus in the cancer.

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Verified sites

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

Azienda Sanitaria Universitaria Friuli Centrale
Verified
Udine, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy
Universita' Degli Studi Di Verona
Responsive
Verona, Italy

Trial locations

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Investigated drugs

Tremelimumab
is a type of immunotherapy that helps the body's immune system fight cancer. It works by blocking a protein that usually stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.
Durvalumab
is another immunotherapy medication that also helps the immune system attack cancer cells. It blocks a different protein that can prevent the immune system from working effectively against cancer, thereby enhancing the body's natural defenses to fight the cancer.

What is already known about the treatment

Tremelimumab
Tremelimumab is administered intravenously and is currently being studied in clinical trials for its potential use in treating certain types of cancer. It is primarily indicated for gastric or gastroesophageal junction cancer with specific genetic characteristics, such as microsatellite instability. Tremelimumab works by targeting and inhibiting a protein called CTLA-4 on T-cells, which enhances the immune system's ability to attack cancer cells. It is classified as an immune checkpoint inhibitor.
Durvalumab
Durvalumab is given through intravenous infusion and is under investigation in clinical trials for its effectiveness in treating specific cancers. It is used for gastric or gastroesophageal junction cancer with microsatellite instability. Durvalumab functions by blocking the PD-L1 protein on cancer cells, allowing the immune system to better recognize and destroy these cells. It belongs to the class of medications known as immune checkpoint inhibitors.

Investigated diseases

Gastric Cancer – This disease involves the growth of cancerous cells in the stomach lining. It can also occur at the junction between the stomach and the esophagus. The cancer is characterized by its ability to grow and invade nearby tissues. In some cases, it may spread to other parts of the body, although the focus here is on non-metastatic cases. The progression of gastric cancer can vary, with some tumors growing slowly and others more rapidly. Microsatellite instability is a feature of some gastric cancers, indicating a specific type of genetic change within the tumor cells.