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Study of Nivolumab, Ipilimumab, Relatlimab, and Daratumumab in Patients with Recurrent and Metastatic Colon Cancer

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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 colon cancer, specifically in cases where the cancer has returned or spread to other parts of the body. The study is investigating the effectiveness of a medication called Nivolumab, which may be used alone or in combination with other medications. These combinations include Nivolumab with Ipilimumab, Nivolumab with an anti-LAG3 agent known as Relatlimab, and Nivolumab with Daratumumab. The purpose of the study is to see if these treatments can produce a significant response in patients with a specific marker in their tumors.

The study involves patients with two types of colorectal cancer: those with MSI Positive Colorectal Cancer and those with MSI Negative Colorectal Cancer. MSI stands for microsatellite instability, which is a condition of genetic hypermutability that results from impaired DNA mismatch repair. The trial aims to determine the objective response rate, which is a measure of how well the cancer responds to the treatment, in both types of patients.

Participants in the study will receive the treatments through intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor the response of the cancer to these treatments over time. The trial is designed to provide valuable information on the potential benefits of these treatment combinations for patients with recurrent and metastatic colon 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

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, performance status, and confirmed colorectal cancer diagnosis.

    Participants must have measurable disease and undergo testing for microsatellite instability (MSI) status.

    Consent is required, and participants must agree to comply with study procedures and use birth control as specified.

  2. Step 2

    Treatment initiation

    Treatment begins with the administration of nivolumab alone or in combination with other medications.

    The medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

  3. Step 3

    Nivolumab administration

    Nivolumab is administered as a 10 mg/mL concentrate for solution for infusion.

    The frequency and duration of administration depend on the specific treatment plan assigned to the participant.

  4. Step 4

    Combination therapy

    Participants may receive nivolumab in combination with other medications such as ipilimumab, daratumumab, or relatlimab.

    Each combination is designed to target specific aspects of the cancer and is administered intravenously.

  5. Step 5

    Monitoring and assessment

    Throughout the trial, participants undergo regular monitoring to assess the response to treatment.

    This includes imaging tests like CT or MRI to measure changes in the disease.

  6. Step 6

    Completion and follow-up

    The trial is expected to continue until September 2024, with follow-up assessments to evaluate long-term outcomes.

    Participants are monitored for any side effects and overall health status after completing the treatment phase.

Who can join the trial?

9 criteria

  • Men and women who are **18 years or older** can participate.
  • Participants must have an **ECOG performance status** of 0 to 1, which means they should be fully active or have some symptoms but can still do light work.
  • Participants must have **colorectal cancer** confirmed by a tissue sample test.
  • The disease must be **measurable** using a CT or MRI scan.
  • Participants need to have their **MSI status** tested. This refers to a specific characteristic of the cancer cells. Depending on the results, they will be placed in different groups within the study.
  • Participants must have **adequate organ function**, which will be checked through specific lab tests.
  • Participants must use an **acceptable form of birth control** during the study. Women who can have children should continue using birth control for 23 weeks after the last dose of the study drug, and men should do so for 31 weeks if they are sexually active with women who can have children.
  • Participants must provide **signed informed consent**, which means they agree to participate after understanding the study details.
  • Participants must be **willing and able to follow the study procedures**. Those in the C3 Cohort should not have received treatment for their metastatic disease.

Who cannot join the trial?

10 criteria

  • Patients who have had another type of cancer in the past, except for certain skin cancers that have been treated.
  • Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals.
  • Patients who have a history of severe allergic reactions to any of the drugs used in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an autoimmune disease, which is when the body's immune system attacks its own healthy cells.
  • Patients who have received a live vaccine within 30 days before starting the study treatment.
  • Patients who have a condition that affects the brain or nerves, such as seizures or a history of stroke.
  • Patients who have uncontrolled heart problems, like heart failure or a recent heart attack.
  • Patients who have a history of drug or alcohol abuse that could interfere with their ability to participate in the study.
  • Patients who are taking medications that suppress the immune system, which are drugs that lower the body's ability to fight infections and other diseases.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to help the body's immune system fight cancer cells. It works by blocking a protein that prevents the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

  • Ipilimumab

    is used in combination with Nivolumab in this trial. It also helps the immune system attack cancer cells by blocking a different protein that can stop the immune system from working effectively against cancer.

  • BMS-986016

    is an experimental medication used in combination with Nivolumab. It targets a specific protein involved in regulating the immune system, potentially enhancing the ability of the immune system to fight cancer.

  • Daratumumab

    is another medication used in combination with Nivolumab in this trial. It is an antibody that targets a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its effectiveness in treating recurrent and metastatic colon cancer, particularly in patients with specific biomarkers. The main therapeutic indication for Nivolumab is its use in various types of cancer, including colorectal cancer. It works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

  • Ipilimumab

    Ipilimumab is administered through an intravenous infusion, usually in a hospital or clinic. It is being investigated in combination with Nivolumab for its potential to treat recurrent and metastatic colon cancer. The primary therapeutic use of Ipilimumab is in cancer treatment, particularly melanoma and other cancers. It functions by targeting CTLA-4, a protein receptor that downregulates the immune system, thereby enhancing the body's immune response against cancer cells. Ipilimumab is also classified as an immune checkpoint inhibitor.

  • BMS-986016

    BMS-986016 is given as an intravenous infusion and is currently under investigation in combination with Nivolumab for treating colon cancer with specific biomarkers. Its main therapeutic indication is in cancer treatment, focusing on enhancing immune response. BMS-986016 works by inhibiting the LAG-3 protein, which can suppress immune activity, thus promoting a stronger attack on cancer cells. It is classified as an immune checkpoint inhibitor.

  • Daratumumab

    Daratumumab is administered via intravenous infusion, typically in a medical facility. It is being studied in combination with Nivolumab for its potential benefits in treating colon cancer. The main therapeutic use of Daratumumab is in the treatment of multiple myeloma, a type of blood cancer. It targets the CD38 protein on the surface of certain cancer cells, leading to their destruction by the immune system. Daratumumab is classified as a monoclonal antibody.

Investigated diseases

  • MSI Negative Colorectal Cancer

    This type of colorectal cancer is characterized by the absence of microsatellite instability, meaning the DNA mismatch repair system is functioning normally. It typically progresses through the accumulation of genetic mutations that lead to uncontrolled cell growth in the colon or rectum. The disease can spread to nearby tissues and organs, and in advanced stages, it may metastasize to distant parts of the body. Patients may experience symptoms such as changes in bowel habits, abdominal pain, and weight loss as the disease progresses.

  • MSI Positive Colorectal Cancer

    This form of colorectal cancer is marked by the presence of microsatellite instability, indicating a defect in the DNA mismatch repair system. It often progresses more slowly than MSI negative types and may respond differently to certain treatments. The cancerous cells can grow and invade surrounding tissues, potentially spreading to other areas of the body. Symptoms may include rectal bleeding, persistent abdominal discomfort, and fatigue as the disease advances.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516004-42-01Protocol codeCA209-142Estimated enrolment298 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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