Not recruiting

Study of Retifanlimab, Capecitabine, and Oxaliplatin for First-Line Treatment in Patients with Metastatic Esophagogastric Cancer

Verified siteInvestigationalNo 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 cancer known as metastatic upper gastrointestinal cancer, which includes cancer of the esophagus and stomach. The study is investigating a treatment that combines three components: Retifanlimab (INCMGA00012), Capecitabine, and Oxaliplatin. Retifanlimab is a medication given as a solution for infusion, which means it is administered directly into the bloodstream through a vein. Capecitabine and Oxaliplatin are chemotherapy drugs that are commonly used to treat various types of cancer.

The purpose of this study is to explore how these treatments affect the immune system's response to the cancer. Specifically, the study will look at changes in a protein called Interferon gamma (IFN-γ) and the presence of certain immune cells known as cytotoxic T cells in the tumor environment. These immune cells are important because they can help the body fight cancer. The study will involve several stages, starting with initial treatment using Capecitabine and Oxaliplatin, followed by maintenance treatment with Retifanlimab. The study will also include a comparison with a placebo to better understand the effects of the treatment.

Participants in the study will receive the treatment over a period of time, with regular assessments to monitor their response. The study aims to gather information on overall survival, progression-free survival, and the response rate to the treatment. Additionally, it will track any side effects experienced by participants and assess their quality of life during the study. The ultimate goal is to determine if this combination of treatments can provide a beneficial effect for patients with this type of cancer.

The research process

The trial runs in 5 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 a review of medical history and a physical examination.
Eligibility is determined by specific criteria, such as having a confirmed diagnosis of metastatic or irresectable cancer of the stomach or esophagus, and being over 18 years old.
Step 2
Treatment initiation
The treatment begins with the administration of Capecitabine and Oxaliplatin, known as CapOx. These medications are used to treat cancer by interfering with the growth of cancer cells.
Capecitabine is taken orally, while Oxaliplatin is given through an intravenous infusion. The specific dosage and frequency are determined by the healthcare provider.
Step 3
Monitoring and evaluation
After two courses of CapOx, the patient's response to the treatment is evaluated. This involves monitoring changes in the tumor and assessing any side effects.
Regular blood tests and imaging studies are conducted to track the progress of the treatment.
Step 4
Maintenance therapy
Following the initial treatment phase, maintenance therapy with Retifanlimab is initiated. Retifanlimab is administered as a solution for infusion, targeting specific proteins to help the immune system fight cancer.
This phase lasts for 8 weeks, during which the patient's response to the therapy is closely monitored.
Step 5
Final assessment
At the end of the maintenance therapy, a final assessment is conducted to evaluate the overall effectiveness of the treatment.
The assessment includes measuring the expression of certain proteins and the number of immune cells in the tumor.

Who can join the trial?

9 criteria

Patients must provide written informed consent, which means they agree to participate in the study after understanding all the details.
Patients must have a specific condition called **dMMR**, identified by a test called **IHC** that checks for certain proteins in the body.
The primary tumor or cancer spread must be accessible for repeat fresh tissue samples, known as biopsies.
Patients must be adults, meaning they are over 18 years old.
Patients must have a confirmed diagnosis of a type of cancer in the stomach or esophagus that is either metastatic (spread to other parts of the body) or cannot be surgically removed, and is **HER2 negative**. If the cancer is **HER2 positive**, patients can still participate if they cannot be treated with a drug called trastuzumab.
Patients must not have received chemotherapy or radiotherapy for cancer that cannot be surgically removed or has spread, except for certain allowed treatments.
Patients must have cancer that can be measured or evaluated using a specific method called **RECIST 1.1**.
Patients must have an **ECOG performance status** of 0-2, which is a scale that measures how well they can perform daily activities.
Patients must have adequate liver, kidney, and blood function.

Who cannot join the trial?

10 criteria

Patients with other types of cancer that are not related to the esophagus or stomach.
Patients who have received certain treatments that might interfere with the study.
Patients with serious health conditions that could make participation unsafe.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are pregnant or breastfeeding.
Patients who have allergies to the study medications.
Patients who are participating in another clinical trial.
Patients with a history of certain immune system disorders.
Patients who have had a recent major surgery.
Patients with active infections that require treatment.

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Verified sites

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands

Trial locations

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Investigated drugs

Anti-PD-1
This medication is used to help the immune system recognize and attack cancer cells. It works by blocking a specific protein on the surface of immune cells, which can prevent the immune system from attacking the cancer. In this trial, it is used to maintain the treatment effect after initial chemotherapy.
Capecitabine
This is a type of chemotherapy drug that is used to treat various types of cancer, including esophagogastric cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, it is used as part of the initial treatment to reduce the size of the tumor.
Oxaliplatin
This is another chemotherapy drug that is often used in combination with other medications to treat cancer. It works by damaging the DNA in cancer cells, which can stop them from multiplying. In this trial, it is used alongside capecitabine as part of the initial treatment to help shrink the tumor.
Retifanlimab
This is an investigational medication that is being studied for its ability to enhance the immune system's response against cancer cells. It is used in this trial as a maintenance therapy to continue the fight against cancer after the initial chemotherapy treatment.

Retifanlimab

What is already known about the treatment

Retifanlimab – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating certain types of gastrointestinal cancers, specifically those affecting the esophagus and stomach. It is an investigational drug, meaning it is not yet approved for general medical use but is being evaluated for its potential benefits. Retifanlimab works by blocking the PD-1 protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that enhances the body's immune response against cancer.

Investigated diseases

Metastatic Upper Gastrointestinal Cancer – This disease involves the spread of cancer cells from the primary site in the upper gastrointestinal tract, which includes the esophagus and stomach, to other parts of the body. It typically begins with abnormal cell growth in the lining of the esophagus or stomach, which can invade nearby tissues and organs. As the cancer progresses, it can metastasize to distant organs such as the liver, lungs, or lymph nodes. Symptoms may include difficulty swallowing, weight loss, and abdominal pain. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression. The disease is often diagnosed at an advanced stage due to the subtlety of early symptoms.