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Study of Pembrolizumab with Drug Combination for Patients with Microsatellite Stable Metastatic Colorectal Cancer with High Immune Infiltrate

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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 the treatment of microsatellite stable metastatic colorectal cancer, a type of colon cancer that has spread to other parts of the body and does not have changes in certain DNA sequences. The study involves a combination of treatments, including chemotherapy and immunotherapy. The chemotherapy regimen includes XELOX, which is a combination of two drugs: capecitabine and oxaliplatin. Additionally, the study uses bevacizumab, a medication that helps prevent the growth of blood vessels that feed tumors. The immunotherapy component involves pembrolizumab, also known by its code name MK-3475, which helps the immune system recognize and attack cancer cells.

The purpose of this study is to evaluate how effective this combination of treatments is as a first-line therapy for patients with this specific type of colorectal cancer that shows a high level of immune cells within the tumor. The study will monitor patients over a period of time to see how many remain alive and without disease progression after 10 months. This is a non-randomized, multicenter study, meaning that all participants will receive the same treatment, and the study is conducted at multiple locations.

Participants in the study will receive the treatments through intravenous infusions, which means the medications are delivered directly into the bloodstream through a vein. The study will last for up to 24 months, during which time the patients' health and response to the treatment will be closely monitored. The study aims to provide valuable insights into the effectiveness of combining chemotherapy and immunotherapy for treating this type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the patient meets the inclusion criteria.

  2. Step 2

    Treatment initiation

    The treatment begins with the administration of pembrolizumab through an intravenous infusion. This medication is part of the immunotherapy approach.

    In addition, bevacizumab is administered via intravenous infusion. This medication is used to inhibit the growth of blood vessels that supply the tumor.

  3. Step 3

    Chemotherapy administration

    Oxaliplatin is given through an intravenous infusion. This is a chemotherapy drug that helps to kill cancer cells.

    Capecitabine is taken orally in the form of film-coated tablets. This medication is also a chemotherapy drug and is taken as prescribed by the healthcare provider.

  4. Step 4

    Ongoing treatment

    The treatment regimen continues with regular administration of the medications. The frequency and dosage are determined by the healthcare provider based on the patient's response and tolerance to the treatment.

  5. Step 5

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to evaluate the effectiveness of the treatment. This includes imaging studies and other tests to assess the progression of the cancer.

    The primary goal is to determine the percentage of patients who are alive and without progression at 10 months.

  6. Step 6

    Completion of trial

    The trial is expected to conclude by June 2026. At the end of the trial, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

18 criteria

  • Must be **18 years** or older.
  • Must have **adequate liver function**:
    • AST/ALT levels should be less than or equal to 5 times the upper limit of normal (ULN).
    • Total bilirubin should be less than or equal to 2 times the ULN.
    • Alkaline phosphatase should be less than or equal to 5 times the ULN.
    • Must have a **creatinine clearance** greater than 50 mL/min, which is a measure of kidney function.
    • Must have **proteinuria** (protein in urine) less than 2+ on a dipstick test or less than or equal to 1 gram in a 24-hour urine collection.
    • Must be a **beneficiary of the social security system**.
    • Must have received **information about the study** and signed the informed consent form.
    • Must have both **MSS and pMMR metastatic colorectal adenocarcinoma**, which means a specific type of colorectal cancer that has spread to other parts of the body.
    • Patients who had chemotherapy or radiotherapy after surgery for their primary tumor can join if their cancer returned more than 6 months after treatment.
    • Must have a **high immune response**, which is determined by a test on the primary tumor.
    • Must have **unresectable cancer** with at least one measurable metastatic target, meaning the cancer cannot be removed by surgery and can be measured by specific criteria.
    • Must have a **WHO performance status** of 1 or less, which indicates the ability to carry out daily activities.
    • Must not have **severe neuropathy** (nerve damage) of grade 2 or higher.
    • Must have a **life expectancy** of more than 3 months.
    • Must have **adequate blood function**:
      • Neutrophils (a type of white blood cell) greater than 1,500 per mm3.
      • Platelets (cells that help with blood clotting) greater than 100,000 per mm3.
      • Hemoglobin (a protein in red blood cells) greater than 9 g/dL.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had previous treatments that might interfere with the study.
  • Patients with serious health conditions that could make it unsafe to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have allergies to the study medications.
  • Patients who are participating in another clinical trial.
  • Patients who have had a recent major surgery.
  • Patients with infections that are not well controlled.
  • Patients with a history of certain heart problems.
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy that helps the body's immune system fight cancer cells. It works by blocking a specific protein on the surface of immune cells, allowing them to better recognize and attack cancer cells.

  • XELOX

    is a combination of two chemotherapy drugs, capecitabine and oxaliplatin. Capecitabine is taken orally and is converted into a substance that interferes with the growth of cancer cells. Oxaliplatin is given intravenously and works by damaging the DNA of cancer cells, preventing them from dividing and growing.

  • Bevacizumab

    is a medication that targets and inhibits a protein called vascular endothelial growth factor (VEGF). By blocking VEGF, bevacizumab helps prevent the growth of new blood vessels that tumors need to grow and spread.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered intravenously and is currently being studied in combination with other drugs for treating microsatellite stable metastatic colorectal cancer with a high immune infiltrate. It is an approved medication in the field of oncology, widely discussed in medical literature for its role in cancer immunotherapy. The main therapeutic indication is for various types of cancer, including colorectal cancer. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, enhancing the immune system's ability to detect and destroy cancer cells. It is classified as a monoclonal antibody and an immune checkpoint inhibitor.

  • XELOX

    XELOX is a combination of two chemotherapy drugs, capecitabine and oxaliplatin, administered orally and intravenously, respectively. It is used in the treatment of colorectal cancer and is well-documented in medical literature as a standard chemotherapy regimen. The main therapeutic indication is for colorectal cancer, particularly in advanced stages. XELOX works by interfering with the DNA replication process in cancer cells, leading to cell death. It is classified as an antineoplastic agent.

  • Bevacizumab

    Bevacizumab is administered intravenously and is used in combination with other medications for treating various cancers, including colorectal cancer. It is an established medication in oncology, with extensive documentation in medical literature. The main therapeutic indication is for inhibiting tumor growth by blocking the formation of new blood vessels. At the molecular level, bevacizumab targets and inhibits vascular endothelial growth factor (VEGF), preventing the supply of nutrients to tumors. It is classified as an angiogenesis inhibitor.

Investigated diseases

Microsatellite Stable (MSS) Metastatic Colorectal Cancer – This type of colorectal cancer is characterized by the absence of microsatellite instability, meaning the DNA repair system is functioning normally. It is a form of cancer that has spread beyond the colon or rectum to other parts of the body. The disease often presents with a high immune infiltrate, indicating a significant presence of immune cells within the tumor. As the cancer progresses, it may lead to symptoms such as changes in bowel habits, abdominal pain, and weight loss. The progression of the disease is typically monitored through imaging studies to assess tumor growth and spread.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515788-73-00Protocol codeFFCD1703Estimated enrolment55 patientsSponsorFondation Franc.Cancerologie Digestive

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).