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Study on Pre-Operative Treatment for Breast Cancer Using Nivolumab, Ipilimumab, and Relatlimab for Patients with Breast Cancer

Registered 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 breast cancer. The trial involves the use of several medications, including nivolumab, ipilimumab, and relatlimab. These medications are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein. The purpose of the study is to determine if these medications, either alone or in combination, can help achieve a complete response in the cancer before surgery. A complete response means that no cancer cells are found in the breast or nearby lymph nodes when examined under a microscope.

Participants in the study will receive treatment with these medications for a short period before their scheduled surgery. The study will monitor how well the cancer responds to the treatment and will also keep track of any side effects that may occur. The trial aims to understand the effectiveness of these medications in shrinking the cancer and improving outcomes for patients with breast cancer.

Throughout the study, various assessments will be conducted, including imaging tests like MRI to evaluate the response of the cancer to the treatment. The study will also look at the overall survival and event-free survival of participants, which refers to the length of time patients live without the cancer returning or worsening. By exploring these treatments, the trial hopes to find new ways to improve the management of breast cancer and enhance the quality of life for those affected by this disease.

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

    Joining the trial

    Upon joining the trial, a signed written informed consent is required. This confirms understanding and agreement to participate in the study.

    Eligibility is confirmed based on criteria such as age (18 years or older), gender (female), and specific health conditions related to breast cancer.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status. This includes examining the breast cancer stage and nodal status through various tests like ultrasound or MRI.

    The tumors must meet specific criteria, such as size and type, to proceed with the trial.

  3. Step 3

    Treatment phase

    The treatment involves the administration of medications through intravenous routes. The medications used are nivolumab, ipilimumab, and relatlimab.

    The objective is to determine if these medications, either alone or in combination, can induce a complete response before surgery.

  4. Step 4

    Monitoring and follow-up

    Throughout the treatment, regular monitoring is conducted to observe the response to the medications and any side effects.

    The primary goal is to achieve a pathological complete response, meaning no remaining invasive tumor cells are detected.

  5. Step 5

    Post-treatment evaluation

    After the treatment phase, a post-treatment evaluation is performed. This includes assessing the incidence and severity of any adverse events.

    Additional evaluations include radiological response using MRI, event-free survival, and overall survival.

  6. Step 6

    End of trial

    The trial concludes with a final assessment of the immune activation after the pre-operative treatment.

    The estimated end date for the trial is January 1, 2031.

Who can join the trial?

8 criteria

  • Must provide a signed written informed consent, which means you agree to participate after being informed about the study.
  • Must be 18 years or older.
  • Must be of female gender.
  • Must have a WHO performance status of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
  • Must have resectable primary breast cancer at stage I-III, meaning the cancer can be surgically removed. The lymph nodes must be checked using specific tests like ultrasound or PET-CT scan.
  • The tumors must be larger than 5 mm as determined by an MRI scan. Specific types of breast cancer are required, such as:
    • TNBC (Triple Negative Breast Cancer) with certain characteristics.
    • Luminal B breast cancer with specific hormone receptor levels.
    • Patients with multiple breast cancer tumors are eligible if they have triple negative breast cancer and meet certain criteria for immune cells in the tumor.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with breast cancer cannot participate.
  • Only female patients are eligible for this study.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
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Investigated drugs

  • Nivolumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is being used before surgery to see if it can help shrink breast cancer tumors.

  • Ipilimumab

    is another immune checkpoint inhibitor. It helps activate your immune system to fight cancer by targeting a specific protein that usually helps keep the immune system in check. In this study, it is being tested in combination with nivolumab to see if the two drugs together can improve the body's ability to fight breast cancer.

  • Relatlimab

    is also an immune checkpoint inhibitor. It works by targeting a different protein than ipilimumab, aiming to further enhance the immune system's response against cancer cells. In this trial, it is being combined with nivolumab to explore if this combination can lead to better outcomes for breast cancer patients.

  • Novel IO combinations

    refer to new and innovative immune-based therapies that are being tested in combination with nivolumab. These therapies are designed to boost the immune system's ability to fight cancer in different ways, and the trial is investigating if these new combinations can lead to a complete response in breast cancer before surgery.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an injection into a vein, typically given in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in treating breast cancer, particularly in a pre-operative setting. The main therapeutic indication for nivolumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

  • Ipilimumab

    Ipilimumab is given as an intravenous infusion, usually in a healthcare facility. It is being explored in clinical trials for its potential to treat breast cancer when used in combination with other immune therapies. The primary therapeutic use of ipilimumab is to enhance the body's immune response against cancer cells. It functions by targeting a protein called CTLA-4, which normally helps keep the immune system in check, thereby boosting the immune response against cancer. Ipilimumab is also classified as an immune checkpoint inhibitor.

  • Relatlimab

    Relatlimab is administered through an infusion into a vein, typically in a clinical setting. It is under investigation in clinical trials for its role in treating breast cancer, especially when used alongside other immunotherapies. The main therapeutic goal of relatlimab is to stimulate the immune system to fight cancer more effectively. It acts by inhibiting a protein called LAG-3, which can suppress the immune response against cancer cells. Relatlimab is part of the immune checkpoint inhibitor class of drugs.

Investigated diseases

Breast cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body. The growth of cancer cells can form a lump or mass in the breast. Over time, these cancerous cells can invade surrounding tissues. The progression of breast cancer varies, with some types growing slowly and others more rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515080-54-00Protocol codeM18BELEstimated enrolment120 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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