Not recruiting

Study on Pembrolizumab for Patients with Localized Non-Metastatic MSI/dMMR Tumors or EBV+ 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 certain types of cancers, specifically MSI/dMMR tumors and EBV-positive gastric cancer. These are specific kinds of cancers that have unique characteristics. The treatment being tested in this study is called pembrolizumab, which is also known by its code name MK-3475. Pembrolizumab is a type of medication that is given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The purpose of this study is to evaluate how effective pembrolizumab is in treating patients with these specific types of cancers that have not spread to other parts of the body.

Participants in the study will receive pembrolizumab as part of their treatment plan. The study will take place over a period of time, during which patients will receive the medication and be monitored by healthcare professionals. The goal is to see how well the treatment works in reducing or eliminating the cancer cells. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of pembrolizumab. The study will also look at the safety of the treatment and any potential side effects that may occur.

Throughout the study, participants will have regular visits with their healthcare team to track their progress and ensure their well-being. The study aims to provide valuable information on the effectiveness of pembrolizumab in treating these specific types of cancers, which could lead to improved treatment options for patients in the future. The study is expected to continue until 2029, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatment.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of MSI/dMMR tumors or EBV+ gastric cancer through specific tests.
The assessment involves a review of medical history, physical examination, and laboratory tests to ensure adequate bone marrow, liver, and kidney function.
Step 2
Treatment initiation
The treatment phase begins with the administration of pembrolizumab, a medication given as an intravenous infusion.
The dosage is 25 mg/mL and is administered according to the study protocol. The frequency and duration of administration are determined by the study team.
Step 3
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and to identify any side effects. This includes scheduled visits, laboratory tests, and imaging studies.
The primary goal is to evaluate the rate of complete pathological response after surgery, defined as no viable tumor cells in the tumor or nodal site.
Step 4
Surgery
Surgery is performed to remove the tumor. The success of the surgery is evaluated based on the absence of viable tumor cells and the rate of surgical complications.
The percentage of patients achieving a major pathological response is also assessed.
Step 5
Post-surgery evaluation
After surgery, further evaluations are conducted to monitor recovery and any potential recurrence of cancer.
The study also tracks the overall survival, progression-free survival, and quality of life of participants.
Step 6
Long-term follow-up
Participants are followed up for an extended period to assess long-term outcomes, including the development of any second cancers and the overall effectiveness of the treatment.
The study is expected to continue until November 2029, with ongoing assessments and data collection.

Who can join the trial?

9 criteria

Must be at least 18 years old on the day of signing the consent form.
Must have a confirmed localized tumor that has not spread to other parts of the body. This includes certain types of colorectal, rectal, gastric, gastro-oesophageal, oesophageal, endometrial, or small bowel cancers.
Must have specific types of tumors known as MSI/dMMR or EBV-positive gastric cancers. These are determined through special tests on the tumor tissue.
Must have an ECOG Performance Status of 0 to 1, which means the patient is fully active or has some symptoms but can still carry out light work.
Must have adequate blood, liver, and kidney function as determined by specific medical tests.
Must have medical or health insurance coverage.
Must be willing and able to attend scheduled visits, follow treatment plans, and undergo necessary tests and procedures.
If of childbearing potential, must agree to use effective birth control methods or abstain from heterosexual activity during the study and for a specified period after the study treatment.
Must have signed and dated an informed consent form approved by an ethics review board.

Who cannot join the trial?

5 criteria

Patients with tumors that are not classified as MSI/dMMR or EBV+ gastric cancer cannot participate. MSI/dMMR refers to specific genetic changes in tumors, and EBV+ means the presence of a virus called Epstein-Barr Virus in gastric cancer.
Patients who have already received treatment for their cancer are not eligible. The study is for those who have not been treated yet.
Patients with cancer that has spread to other parts of the body (metastatic cancer) cannot join the study. The study is for localized cancer, which means it has not spread.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.

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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 De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France
Centre Hospitalier Universitaire Amiens Picardie
Verified
Amiens, France

Trial locations

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Investigated drugs

Pembrolizumab: This medication is used in the trial to help the body's immune system fight cancer. It works by blocking a specific protein on cancer cells, which allows the immune system to better recognize and attack these cells. Pembrolizumab is being tested for its effectiveness in treating certain types of tumors that have not spread to other parts of the body.

Pembrolizumab

What is already known about the treatment

Pembrolizumab – This medication is administered intravenously, typically through an infusion. It is currently well-established in medical literature as an effective treatment for certain types of cancer, particularly those with specific genetic markers like MSI/dMMR tumors or EBV-positive gastric cancer. Pembrolizumab is primarily used for its ability to enhance the body's immune response against cancer cells. At the molecular level, it works by blocking the PD-1 pathway, which cancer cells often exploit to avoid detection by the immune system. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Microsatellite Instability/Deficient Mismatch Repair Tumors
These tumors occur when there are defects in the DNA mismatch repair system, leading to an accumulation of errors during cell division. This condition is often associated with certain types of cancers, including colorectal and endometrial cancers. The tumors can develop in various parts of the body and are characterized by a high mutation rate. Over time, these mutations can lead to the growth and spread of cancerous cells. The progression of these tumors can vary depending on their location and the extent of the mismatch repair deficiency.
Epstein-Barr Virus Positive Gastric Cancer
This type of gastric cancer is associated with the presence of the Epstein-Barr virus in the tumor cells. The virus can contribute to the development of cancer by altering the normal function of infected cells. EBV-positive gastric cancer may present with unique molecular features compared to other gastric cancers. The progression of this cancer can involve the growth and spread of malignant cells within the stomach and potentially to other parts of the body. The presence of the virus can influence the behavior and characteristics of the cancer.