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Study Comparing Nivolumab, Nivolumab with Ipilimumab, or Chemotherapy for Patients with Metastatic Colorectal Cancer with 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 treatments for a type of cancer known as metastatic colorectal cancer, which is characterized by specific genetic features called Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR). The study is exploring the effectiveness of different treatments, including the use of Nivolumab alone, a combination of Nivolumab and Ipilimumab, and various chemotherapy options chosen by the investigator. Nivolumab is also known by its code name BMS936558.

The purpose of the study is to compare how well these treatments work in managing the cancer. Participants will receive one of the treatments, which are administered through an intravenous infusion, meaning the medication is given directly into a vein. The study will take place over a period of time, during which participants will receive regular treatments and be monitored by healthcare professionals. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, participants will undergo regular check-ups and assessments to monitor their health and the progress of the cancer. The study aims to provide valuable information on the effectiveness of these treatments, potentially leading to improved care for individuals with this type of colorectal cancer. The trial is expected to continue until 2026, with the goal of gathering comprehensive data on the outcomes of the different treatment options.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of metastatic colorectal cancer with certain genetic characteristics.

    The study involves different treatment groups, and assignment to a group is randomized.

  2. Step 2

    Treatment group assignment

    Participants are assigned to one of three groups: nivolumab alone, nivolumab with ipilimumab, or a chemotherapy regimen chosen by the investigator.

    The assignment determines the specific treatment plan and schedule.

  3. Step 3

    Nivolumab treatment

    If assigned to the nivolumab group, the treatment involves receiving OPDIVO (nivolumab) 10 mg/mL as a solution for infusion.

    The medication is administered intravenously, following a schedule determined by the study protocol.

  4. Step 4

    Nivolumab and ipilimumab treatment

    If assigned to the combination group, treatment includes both OPDIVO (nivolumab) 10 mg/mL and YERVOY (ipilimumab) 5 mg/mL.

    Both medications are administered as solutions for infusion through an intravenous route, according to the study schedule.

  5. Step 5

    Chemotherapy treatment

    If assigned to the chemotherapy group, treatment may include medications such as irinotecan hydrochloride trihydrate, fluorouracil, bevacizumab, and disodium folinate.

    These medications are administered intravenously, with specific dosages and schedules determined by the investigator.

  6. Step 6

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments are conducted to evaluate the response to treatment.

    Progression-free survival and overall response rates are key measures used to assess the effectiveness of the treatments.

  7. Step 7

    Completion of the study

    The study is estimated to conclude by June 2026, with ongoing assessments and data collection until that time.

    Participants may continue to receive treatment as per the study protocol until the study's end or until specific criteria are met.

Who can join the trial?

7 criteria

  • The patient must have **recurrent** or **metastatic colorectal cancer**. This means the cancer has come back or spread to other parts of the body.
  • The cancer must be confirmed through a test called **histology**, which examines tissue under a microscope.
  • The patient must have a known tumor status of **MSI-H** (Microsatellite Instability High) or **dMMR** (Mismatch Repair Deficient). These are specific characteristics of the cancer cells.
  • The patient must have an **ECOG performance status** of 1 or lower. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • The patient must be at least 18 years old.
  • Both male and female patients can participate.
  • Other specific criteria defined in the study protocol may apply.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the specific type being studied.
  • Patients who have had a different treatment for their cancer that might interfere with the study.
  • Patients with serious health problems that could make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have an allergy to the study medications.
  • Patients who have participated in another clinical trial recently.
  • Patients with certain infections that could affect the study results.
  • Patients who have had a recent surgery that could interfere with the study.
  • Patients with a history of certain heart conditions.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to treat metastatic colorectal cancer. It works by helping the immune system recognize and attack cancer cells more effectively. Nivolumab is often used in cancers that have specific genetic features, such as microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR).

  • Ipilimumab

    is another medication used in combination with Nivolumab in this trial. It also helps the immune system fight cancer by targeting a different part of the immune response. When used together with Nivolumab, it may enhance the overall effectiveness of the treatment against cancer cells.

  • Investigator's Choice Chemotherapy

    refers to a standard chemotherapy treatment selected by the trial investigator. This treatment is used as a comparison to evaluate the effectiveness of Nivolumab alone or in combination with Ipilimumab. Chemotherapy works by using drugs to kill or slow the growth of cancer cells.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently approved and widely studied in medical literature for its use in treating various cancers, including metastatic colorectal cancer with specific genetic markers like Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR). The medication works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells more effectively. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses against cancer.

  • Ipilimumab

    Ipilimumab is also administered via intravenous infusion, usually in a hospital or clinic. It is approved for use in combination with other medications like Nivolumab for treating certain types of cancer, including MSI-H or dMMR metastatic colorectal cancer. Ipilimumab functions by targeting a protein called CTLA-4 on T-cells, which helps to boost the immune response against cancer cells. This medication is part of the immune checkpoint inhibitor class, designed to strengthen the immune system's ability to fight cancer.

Investigated diseases

Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient Metastatic Colorectal Cancer (dMMR) – This type of colorectal cancer is characterized by genetic mutations that affect the DNA repair process, leading to high levels of microsatellite instability. It often begins in the colon or rectum and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can invade nearby tissues and organs. Patients with this condition may experience symptoms such as changes in bowel habits, abdominal pain, and weight loss. The progression of the disease can vary, with some tumors growing slowly while others may advance more rapidly. Understanding the genetic basis of this cancer is crucial for developing targeted therapies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503956-29-00Protocol codeCA209-8HWEstimated enrolment835 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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).