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Study on Pre-Surgery Immunotherapy with Relatlimab, Anti-IL-8 mAb, and Ipilimumab for Early-Stage Colon Cancer Patients

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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 early-stage colon cancer, specifically a type called adenocarcinoma of the colon or rectosigmoid, which is considered non-rectal. The trial is exploring the use of several medications, including Relatlimab, anti-IL8 mAb (also known as BMS-986253), Yervoy (ipilimumab), Opdivo (nivolumab), and Celebrex (celecoxib). These treatments are given as solutions for infusion, which means they are administered directly into the bloodstream through a vein, except for Celebrex, which is taken orally as a capsule.

The purpose of the study is to determine the safety and feasibility of using these treatments before surgery in patients with colon cancer. The study will involve administering these medications over a period of time before the planned surgery. Participants will receive either the study medications or a placebo. The trial aims to see how well the treatments work in reducing the size of the tumor and improving the chances of a successful surgery.

Throughout the study, participants will be closely monitored to assess the effects of the treatments. This includes regular check-ups and tests to ensure the safety of the participants and to gather information on how the treatments are affecting the cancer. The study will also look at how the immune system responds to the treatments, as well as any changes in the tumor itself. The ultimate goal is to find effective treatment combinations that can improve outcomes for patients with early-stage colon 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.

  1. 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.

    A CT scan is performed within 28 days prior to registration to assess the condition of the colon cancer.

  2. Step 2

    Screening tests

    Screening laboratory tests are conducted within 7 days prior to registration. These tests include checks for white blood cell count, hemoglobin levels, liver function, and kidney function.

    A colonoscopy is performed to obtain study-specific biopsies, which are necessary for participation.

  3. Step 3

    Treatment phase

    The treatment phase involves the administration of several medications. Relatlimab, anti-IL8 mAb, Ipilimumab, and Nivolumab are given intravenously as solutions for infusion.

    Additionally, Celecoxib is administered orally in the form of hard capsules.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the safety and feasibility of the treatment. This includes tracking the time to surgery within the predefined 6 to 8 weeks.

    Follow-up assessments are performed to evaluate the response to treatment, including the major pathological response rate and complete response rate.

  5. Step 5

    End of trial

    The trial is estimated to conclude by December 3, 2024. At the end of the trial, a final assessment is conducted to determine the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

12 criteria

  • You must sign a written informed consent form, which means you agree to participate in the study after understanding all the details.
  • If you are a woman who can have children, you need to have a negative pregnancy test before starting the study treatment.
  • If you are a man who is sexually active with a woman who can have children, you must use a reliable method of birth control during the study and for 31 weeks after the last dose of the study drug.
  • A CT-scan (a special type of X-ray) must be done within 28 days before joining the study.
  • You must be at least 18 years old.
  • You must have a type of colon cancer called non-metastatic adenocarcinoma of the colon or rectosigmoid, which means the cancer has not spread to other parts of the body.
  • For certain groups in the study, the cancer must be at a specific stage, indicated as >cT3 and/or N+.
  • A colonoscopy (a test to look inside the colon) must be done after you agree to participate, to take specific tissue samples for the study. If this is not possible, you cannot join the study.
  • You must have a WHO performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
  • Blood tests must show certain levels, including white blood cells, platelets, and hemoglobin, and liver function tests must be within specific limits. These tests should be done within 7 days before joining the study.
  • Your creatinine clearance (a measure of kidney function) must be more than 40 ml/min.
  • If you are a woman who can have children, you must use a suitable method of birth control during the study and for 23 weeks after the last dose of the study drug.

Who cannot join the trial?

5 criteria

  • Patients with a type of cancer called adenocarcinoma of the colon or rectosigmoid, which is not considered rectal cancer, cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
  • Both male and female patients are eligible, so gender is not an exclusion factor.
  • Patients who are considered part of a vulnerable population are not excluded from this study.
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Investigated drugs

  • Immune Checkpoint Inhibitors

    are medications used to help the immune system recognize and attack cancer cells. In this trial, they are given before surgery to see if they can shrink the tumor or make it easier to remove. These drugs work by blocking certain proteins that prevent the immune system from attacking cancer cells.

  • Novel IO Combinations

    refer to new combinations of immunotherapy drugs being tested in this trial. These combinations aim to enhance the body's immune response against colon cancer. The goal is to find out if these new combinations are safe and effective when given before surgery.

What is already known about the treatment

Immune Checkpoint Inhibitors – These medications are administered intravenously and are currently being studied in clinical trials for their effectiveness in treating early-stage colon cancer. They are part of a class of drugs known as immunotherapies, which are gaining attention in medical literature for their potential to enhance the body's immune response against cancer cells. The main therapeutic indication for these drugs in this trial is adenocarcinoma of the colon or rectosigmoid. At the molecular level, immune checkpoint inhibitors work by blocking proteins that prevent the immune system from attacking cancer cells, thereby allowing the immune system to recognize and destroy these cells more effectively.

Investigated diseases

Adenocarcinoma of the Colon or Rectosigmoid (considered as non-rectal) – This is a type of cancer that begins in the glandular cells lining the colon or rectosigmoid area, which is the junction between the colon and rectum. It typically starts as a small growth called a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the colon wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression of the disease can vary, with some cases remaining localized while others may spread to distant parts of the body. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513314-35-00Protocol codeN16NCIEstimated enrolment353 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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).