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Study Comparing Relatlimab-Nivolumab Combination with Regorafenib or Trifluridine-Tipiracil for Patients with Advanced Metastatic Colorectal Cancer

Verified siteRegistered drugNo placebo
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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 Metastatic Colorectal Cancer, a type of cancer that has spread from the colon or rectum to other parts of the body. The study is comparing the effectiveness of a new treatment combination called Relatlimab + Nivolumab with two existing treatments: Regorafenib and a combination of Trifluridine + Tipiracil, also known as TAS-102. The purpose of the study is to see how well these treatments work for patients who have already tried other therapies.

Participants in the study will be randomly assigned to receive either the new treatment combination or one of the existing treatments. The new treatment, Relatlimab + Nivolumab, is given as an infusion, which means it is administered directly into the bloodstream through a vein. The existing treatments, Regorafenib and TAS-102, are taken as tablets by mouth. The study will monitor participants over a period to assess the impact of these treatments on their cancer.

The trial aims to gather information on how these treatments affect overall survival, which is the length of time patients live after starting the treatment. It will also look at other factors such as the response of the cancer to the treatment and any side effects experienced by participants. This information will help determine the best treatment options for patients with Metastatic Colorectal Cancer who have limited options after previous treatments. The study is expected to continue until 2028.

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, including a diagnosis of metastatic colorectal cancer and previous treatment history.

    Documentation of tumor characteristics and KRAS mutation status is required.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the relatlimab-nivolumab combination or one of the standard care therapies: regorafenib or TAS-102 (trifluridine and tipiracil).

  3. Step 3

    Treatment administration

    For those receiving the relatlimab-nivolumab combination, the medication is administered through an intravenous infusion.

    Participants assigned to regorafenib take 40 mg film-coated tablets orally.

    Participants assigned to TAS-102 take either 20 mg/8.19 mg or 15 mg/6.14 mg film-coated tablets orally.

  4. Step 4

    Treatment schedule

    The treatment continues as per the study protocol, with regular monitoring and assessments to evaluate the response to the treatment.

  5. Step 5

    Monitoring and assessments

    Regular assessments are conducted to monitor the disease progression and response to treatment.

    These assessments include imaging studies and laboratory tests to evaluate overall health and treatment effects.

  6. Step 6

    Completion

    The study is estimated to conclude by May 31, 2028, with ongoing evaluations of overall survival and other health outcomes.

Who can join the trial?

9 criteria

  • You must have metastatic colorectal cancer, which means the cancer has spread to other parts of the body.
  • Your cancer must be confirmed as adenocarcinoma, a type of cancer that forms in mucus-secreting glands.
  • The cancer must be metastatic or recurrent and cannot be removed by surgery at the time of joining the study.
  • You must have tried standard cancer treatments and either the cancer got worse during or within about 3 months after the last treatment, or you couldn't tolerate the treatments due to significant side effects.
  • You need to have enough tumor tissue available for testing and meet the study's requirements for PD-L1 expression, a protein that can affect how the immune system responds to cancer.
  • Your KRAS mutation status must be known from previous tests. This is a specific gene change that can affect cancer growth.
  • You must have cancer that can be measured according to specific guidelines. If the only measurable cancer is in an area that was previously treated with radiation, it must show clear signs of getting worse and be measurable.
  • Both men and women can participate in the study.
  • The study includes people who might be considered vulnerable, meaning they may need extra protection or care.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than metastatic colorectal cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or comply with the study requirements cannot participate.
  • Patients who have certain medical conditions that might interfere with the study treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received certain treatments or medications that might interfere with the study cannot participate.
  • Patients who have a history of severe allergic reactions to the study drugs cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.
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Investigated drugs

  • Relatlimab-nivolumab Fixed-dose Combination

    is a combination of two medications used together to help the immune system fight cancer. Relatlimab and nivolumab are both types of drugs called immune checkpoint inhibitors. They work by blocking certain proteins on cancer cells, which helps the immune system recognize and attack the cancer.

  • Regorafenib

    is a medication used to treat certain types of cancer by blocking proteins that help cancer cells grow. It is often used when other treatments have not been successful. Regorafenib works by slowing down the growth and spread of cancer cells.

  • Trifluridine + Tipiracil (TAS-102)

    is a combination of two drugs used to treat cancer. Trifluridine is a type of chemotherapy that interferes with the DNA of cancer cells, preventing them from growing and dividing. Tipiracil helps increase the effectiveness of trifluridine by preventing its breakdown in the body. Together, they work to slow down the growth of cancer cells.

What is already known about the treatment

  • Relatlimab-nivolumab

    This medication is administered as a fixed-dose combination through intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer. The main therapeutic indication is for patients with later-line metastatic colorectal cancer. At the molecular level, it works by blocking specific proteins that inhibit the immune system, thereby enhancing the body's ability to fight cancer cells. It is classified as an immune checkpoint inhibitor.

  • Regorafenib

    This medication is taken orally in tablet form. It is an approved treatment for metastatic colorectal cancer and is well-documented in medical literature. It is used primarily for patients who have not responded to other treatments. Regorafenib works by inhibiting multiple protein kinases, which play a role in tumor growth and progression. It is classified as a multikinase inhibitor.

  • Trifluridine/Tipiracil (TAS-102)

    This medication is administered orally in tablet form. It is an established treatment for metastatic colorectal cancer, particularly in patients who have exhausted other treatment options. The combination works by incorporating into DNA and inhibiting cell division, while tipiracil enhances the bioavailability of trifluridine. It is classified as an antineoplastic agent.

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, abdominal pain, and weight loss. As it advances, it may lead to more severe symptoms depending on the organs affected. The progression can vary greatly among individuals, with some experiencing rapid spread while others have a slower course. Understanding the specific pathways and mechanisms of spread is crucial for managing the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503797-21-00Protocol codeCA224-123Estimated enrolment683 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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