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Study on Dostarlimab Immunotherapy for Patients with Localized Gastric Cancer with Deficient Mismatch Repair or High 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 stomach cancer known as gastric adenocarcinoma, specifically in cases where the cancer is localized and has certain genetic characteristics called deficient mismatch repair (dMMR) and microsatellite instability high (MSI-H). The treatment being tested is an immunotherapy drug called Dostarlimab, which is also known by its code names WBP-285 and TSR-042. This drug is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective Dostarlimab is in treating this type of cancer. Participants in the study will receive the drug and will be monitored over a period of time to see how their cancer responds. The study will look at whether the cancer stops growing or shrinks, and whether patients can avoid surgery to remove the tumor. The study will also assess the safety of the drug and any side effects that may occur.

Participants will undergo regular check-ups, including medical tests and scans, to track their progress. The study aims to determine if Dostarlimab can help patients live longer without their cancer getting worse. This research is important for understanding new ways to treat gastric adenocarcinoma and potentially improve outcomes for patients with this condition.

The research process

The trial runs in 6 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 be informed about the trial's objectives and procedures.
The patient must provide signed and dated informed consent to participate.
Step 2
Initial assessments
The patient will undergo a series of initial assessments to confirm eligibility, including liver and kidney function tests, blood tests, and imaging studies such as CT scans.
A biopsy of the primary tumor will be required to confirm the tumor's status as deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H).
Step 3
Treatment initiation
The patient will begin treatment with dostarlimab, administered as an intravenous infusion.
The dosage is 500 mg, and the frequency and duration of administration will be determined by the study protocol.
Step 4
Monitoring and follow-up
The patient will have regular follow-up visits to monitor the response to treatment and any side effects.
These visits will include physical examinations, blood tests, imaging studies, and possibly additional biopsies.
Step 5
Evaluation of response
At one year from the start of therapy, the patient's response will be evaluated to determine if there is a clinical complete response (cCR).
This evaluation will include checking for the absence of disease progression and negative biopsy results.
Step 6
Continuation or conclusion of treatment
Based on the evaluation results, the patient may continue with the treatment or conclude participation in the study.
Further treatment decisions will be made according to the study protocol and the patient's health status.

Who can join the trial?

17 criteria

The patient must be able to give signed and dated informed consent.
The patient must have adequate liver function, which means certain liver-related blood tests should be within specific limits.
The patient must have blood clotting tests within normal limits, unless they are on blood-thinning medication and their levels are considered safe by the doctor.
The patient must have a tumor assessment using a CT scan of the chest, abdomen, and pelvis, showing no spread of cancer or non-surgical disease.
Female patients must not be pregnant or breastfeeding.
Male patients must agree to certain conditions during the study and for 4 months after the last dose of the study drug.
The patient must provide samples of the primary tumor tissue, which are collected during an upper gastrointestinal (UGI) endoscopy, along with images.
The patient must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
The patient must be registered in a National Health Care System.
The patient must have an ECOG PS of 0-1, which is a scale used to assess how well a patient can perform daily activities.
The patient must be between 18 and 75 years old. Patients over 75 can participate if they meet additional conditions, such as having a certain score on a health questionnaire and being eligible for surgery.
The patient must have a specific type of stomach cancer confirmed by tests, without cancer spread to other parts of the body.
The patient must not have cancer spread to the lining of the abdomen, unless further tests are done if there is doubt.
The patient must not have received previous treatment for localized stomach cancer.
The patient's tumor must have specific genetic characteristics known as dMMR/MSI-H.
The patient must have adequate blood cell counts, including a certain level of neutrophils, platelets, and hemoglobin.
The patient must have adequate kidney function, with specific levels of creatinine and clearance rate.

Who cannot join the trial?

4 criteria

Patients who have had surgery to remove the tumor cannot participate.
Patients who have experienced disease progression, meaning the cancer has gotten worse or spread, are not eligible.
Patients with positive biopsies, which means tests show cancer cells are still present, cannot join the study.
Patients who do not show improvement in their endoscopy results, which is a test that looks inside the body, are excluded.

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Verified sites

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

Verified
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
Verified
Besancon University Hospital Center
Besançon, France
Responsive
Istituto Oncologico Veneto
Padua, Italy

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Investigated drugs

Dostarlimab is an immunotherapy medication used in this clinical trial. It is designed to help the body's immune system recognize and attack cancer cells. In this study, it is being tested for its effectiveness in treating patients with a specific type of stomach cancer that has certain genetic characteristics, known as deficient mismatch repair (dMMR) and/or microsatellite instability high (MSI-H). The goal is to see if patients can achieve a complete response to the treatment without needing surgery.

Dostarlimab

What is already known about the treatment

Dostarlimab – Dostarlimab is administered as an intravenous infusion, typically given in a healthcare setting. It is currently being studied in clinical trials for its effectiveness in treating certain types of cancer, including metastatic gastric cancer. The main therapeutic indication for Dostarlimab is its use in immunotherapy for cancers with specific genetic markers, such as deficient mismatch repair (dMMR) and microsatellite instability-high (MSI-H). At the molecular level, Dostarlimab works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells. It is classified as a monoclonal antibody used in cancer immunotherapy.

Investigated diseases

Metastatic Gastric Cancer – This is a type of cancer that begins in the stomach and has spread to other parts of the body. It often starts in the cells lining the stomach and can invade nearby organs or travel through the bloodstream to distant sites. As the disease progresses, it can cause symptoms such as weight loss, stomach pain, and difficulty swallowing. The spread of cancer cells to other organs, such as the liver or lungs, is a key characteristic of its metastatic nature. This progression can lead to a variety of complications depending on the organs affected. The disease is typically diagnosed at an advanced stage due to its subtle early symptoms.