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Study on the Safety and Effectiveness of Nivolumab and Ipilimumab for Patients with Metastatic Colorectal Cancer with dMMR or MSI

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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 called metastatic colorectal cancer, which is a form of cancer that starts in the colon or rectum and spreads to other parts of the body. Specifically, the study is looking at patients with certain genetic features known as dMMR (deficient mismatch repair) and MSI (microsatellite instability). These features can affect how cancer grows and responds to treatment.

The trial is testing two medications, nivolumab and ipilimumab, which are given together as a combination treatment. Nivolumab, also known by its code name BMS936558, and ipilimumab, also known as BMS734016, are both types of drugs called immunotherapies. They work by helping the body's immune system recognize and attack cancer cells more effectively. The purpose of the study is to evaluate the safety and effectiveness of these two combination treatments over a period of 24 weeks.

Participants in the study will receive the medications through an infusion, which means the drugs are given directly into the bloodstream through a vein. The study will monitor how well the treatments work and any side effects that may occur. The goal is to understand how these treatments can help manage metastatic colorectal cancer with dMMR and MSI features, providing valuable information for future cancer care.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment involves two medications: nivolumab and ipilimumab. Both are administered as a solution for infusion.

    Nivolumab is provided as a 10 mg/mL concentrate, and ipilimumab as a 5 mg/mL concentrate. These are given through an infusion, which is a method of delivering medication directly into the bloodstream over a set period.

    The primary goal during the first 24 weeks is to monitor the safety of the treatment and assess the progression of the disease.

  2. Step 2

    Monitoring and assessment

    Throughout the trial, regular assessments are conducted to monitor the safety and effectiveness of the treatment.

    The main focus is on identifying any significant side effects and evaluating the progression-free survival (PFS) at week 24.

    Additional assessments include the overall response rate (ORR) and overall survival (OS) at various intervals, such as weeks 24, 48, and at 2 years.

  3. Step 3

    Follow-up phase

    After the initial 24-week period, the trial continues with ongoing monitoring to gather long-term data on the treatment's effectiveness and safety.

    The trial is expected to conclude by April 2028, with continuous evaluations to ensure comprehensive data collection.

Who can join the trial?

21 criteria

  • Sign and date a patient informed consent form, showing willingness to follow all study procedures and be available for the study duration.
  • Have adequate blood and organ function, as shown by specific lab test results taken within 7 days before starting the study treatment. This includes:
    • White blood cell count greater than 2000 per microliter.
    • Neutrophils (a type of white blood cell) greater than 1500 per microliter.
    • Platelets (cells that help with blood clotting) greater than 100,000 per microliter.
    • Hemoglobin (a protein in red blood cells) greater than 9.0 grams per deciliter.
    • Serum creatinine level (a measure of kidney function) less than 150 micromoles per liter.
    • Serum bilirubin (a substance made by the liver) less than or equal to 1.5 times the upper normal limit.
    • Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels less than or equal to 3 times the upper normal limit.
    • Prothrombin time (PT)/International normalized ratio (INR) and partial PT (PTT) less than or equal to 1.5 times the upper normal limit, unless on blood-thinning medication with stable INR.
    • Females who can have children must have a negative pregnancy test within 7 days before starting the study treatment.
    • Women who can have children should use effective birth control during treatment and for 5 months after. Men should use condoms during treatment and for 7 months after.
    • Be registered in a national health care system.
    • Be 18 years of age or older.
    • Have an ECOG Performance Status of 0, 1, or 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
    • Have colorectal adenocarcinoma confirmed by tissue examination.
    • Have advanced or metastatic disease that cannot be completely removed by surgery.
    • Have at least one measurable lesion as seen on a CT scan or MRI, and be able to have repeated imaging tests. If the lesion is in an area that was previously treated with radiation, it must show clear growth and be measurable.
    • Have a tumor with dMMR (deficient mismatch repair) and/or MSI (microsatellite instability) status, confirmed by specific tests. This includes:
      • Loss of MMR protein expression using specific antibodies, or
      • Two or more unstable markers by a specific PCR test, with confirmation of dMMR status if needed.
      • Have had no more than one prior line of systemic treatment for metastatic disease. If previous treatment was given before the cancer spread, it must have been completed more than 6 months before the cancer returned or spread.
      • Provide a sample of tumor tissue for research purposes, either as a tissue block or as unstained slides from the primary or metastatic site.

Who cannot join the trial?

3 criteria

  • Patients who do not have **DMMR** or **MSI** metastatic colorectal cancer cannot participate. **DMMR** means the cancer cells have a problem with repairing their DNA, and **MSI** means there are changes in the DNA that affect how the cancer grows.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not included.
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Investigated drugs

  • Nivolumab

    is a medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, it is being tested in combination with another medication to see how well it works in treating metastatic colorectal cancer.

  • Ipilimumab

    is another medication used in cancer therapy. It also helps the immune system fight cancer by targeting specific pathways that cancer cells use to avoid being attacked. In this study, it is combined with nivolumab to evaluate its effectiveness and safety in patients with a specific type of colorectal cancer.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered intravenously and is currently being studied in clinical trials for its effectiveness and safety in treating metastatic colorectal cancer with specific genetic markers. It is primarily used for patients with deficient mismatch repair (dMMR) and/or microsatellite instability (MSI) in their cancer cells. Nivolumab works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor.

  • Ipilimumab

    Ipilimumab is also given intravenously and is under investigation in combination with nivolumab for treating metastatic colorectal cancer with dMMR and/or MSI. This medication is used to enhance the body's immune response against cancer by targeting a protein called CTLA-4 on T-cells, which helps activate the immune system to fight cancer cells. Ipilimumab is categorized as an immune checkpoint inhibitor.

Investigated diseases

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs, such as the liver or lungs. The disease can cause symptoms like changes in bowel habits, blood in the stool, and abdominal discomfort. As it advances, it may lead to more severe symptoms, including weight loss and fatigue. The progression of metastatic colorectal cancer can vary, with some cases spreading more rapidly than others.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518138-10-00Protocol codeNIPISAFE G-106Estimated enrolment93 patientsSponsorAssociation Gercor

sourced from the EU Clinical Trials Register and site verification

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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).