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Study of BMS-986482 alone or with nivolumab, relatlimab or bevacizumab in patients with advanced solid tumors

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 focuses on patients with Advanced Solid Tumors, which are cancers that have spread from where they started to other parts of the body. The study will test a new medication called BMS-986482, both when given alone and in combination with other cancer treatments including nivolumab, relatlimab, and bevacizumab. The main purpose is to determine if BMS-986482 is safe and well-tolerated, and to find the most appropriate dose for future treatment.

During the study, participants will receive BMS-986482 either as tablets taken by mouth, or in combination with other medications that are given through injections under the skin or through an intravenous infusion (a slow drip into a vein). The study includes different groups of patients with various types of advanced cancers, such as non-small cell lung cancer, melanoma, colorectal cancer, breast cancer, and other solid tumors.

The researchers will monitor participants' health throughout the study to check for any side effects from the treatment. They will also look at how well the medications work together and measure if the tumors respond to the treatment. The study includes regular medical check-ups and imaging tests to track the progress of the disease.

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

    You will undergo screening to confirm that you have an advanced solid tumor that cannot be surgically removed or has spread to other parts of your body.

    A tumor tissue sample (biopsy) taken within one month before screening will be required if it is safe to obtain one.

  2. Step 2

    Treatment assignment

    Based on your specific type of cancer, you will be assigned to receive either:

    - BMS-986482 alone as oral tablets

    - BMS-986482 combined with nivolumab (given as an injection under the skin)

    - BMS-986482 combined with nivolumab and relatlimab (given as an injection under the skin)

    - BMS-986482 combined with bevacizumab (given through an infusion into a vein)

  3. Step 3

    Treatment period

    You will receive the assigned treatment according to a specified schedule.

    Regular assessments will be performed to monitor how your tumor responds to the treatment.

    Your health status will be closely monitored for any side effects or serious health issues.

  4. Step 4

    Follow-up assessments

    After completing the treatment, you will have follow-up visits to check your health status.

    The study team will continue to monitor any side effects that may occur.

    Imaging scans will be performed to assess how your tumor has responded to the treatment.

  5. Step 5

    Study completion

    The study will continue until May 2029 or until other completion criteria are met.

    Your participation may end earlier if your disease progresses or if you experience unacceptable side effects.

Who can join the trial?

16 criteria

  • Must be 18 years or older
  • Must have an advanced solid tumor that cannot be surgically removed or has spread to other parts of the body (metastatic)
  • Must be able to provide a tumor tissue sample (biopsy) taken within one month before screening, if it is safe to do so
  • For initial study parts: may have specific types of cancer including:
    • Lung cancer
    • Head and neck cancer
    • Colorectal cancer (cancer of the large intestine)
    • Stomach cancer
    • Bladder cancer
    • Pancreatic cancer
    • Melanoma (skin cancer)
    • Breast cancer
    • For specific study parts (1B1 and 2B1): must have non-small cell lung cancer and specific genetic markers
    • For lung cancer participants: must have previously received platinum-based chemotherapy and immunotherapy (anti-PD-(L)1 therapy) if eligible
    • For melanoma study parts: must have previously received melanoma treatments (except eye melanoma, which is not eligible)
    • For colorectal cancer participants: must have cancer that does not respond to or cannot tolerate standard treatments (fluoropyrimidine and oxaliplatin)
    • Both men and women may participate

Who cannot join the trial?

15 criteria

  • Previous history of adverse reactions (serious negative effects) to similar medications
  • Active autoimmune disease (condition where body's immune system attacks healthy cells) that requires systemic treatment
  • Untreated brain metastases (cancer that has spread to the brain)
  • Severe heart conditions including heart failure or uncontrolled high blood pressure
  • Active or chronic hepatitis B or C infection
  • Known HIV infection or AIDS
  • Other active cancer requiring treatment (except for certain skin cancers)
  • Major surgery within 4 weeks before starting the study
  • Current participation in other clinical trials
  • Pregnant or breastfeeding women
  • Serious organ dysfunction (poor functioning of vital organs like liver, kidneys)
  • History of organ transplant
  • Regular use of medications that could interfere with the study drugs
  • Unable to follow study procedures or attend scheduled visits
  • Any condition that, in the opinion of the study doctor, makes participation unsafe
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Investigated drugs

  • BMS-986482

    is an investigational medication being studied for the treatment of advanced solid tumors. This is a new drug that is being tested to understand how safe and effective it is in cancer treatment.

  • Nivolumab

    is a medication given as an injection under the skin (subcutaneous). It works by helping your immune system fight cancer cells. It belongs to a group of medicines called immunotherapy drugs.

  • Relatlimab

    is an immunotherapy medication that is given in combination with nivolumab as a fixed-dose combination injection under the skin. It helps activate your immune system to fight cancer cells.

  • Bevacizumab

    is a medication that works by blocking the growth of new blood vessels that feed tumors. This can help slow down or stop tumor growth. It is commonly used in the treatment of various types of cancer.

What is already known about the treatment

  • BMS-986482

    An investigational medication being studied in clinical trials for the treatment of advanced solid tumors. It is being evaluated both as a standalone therapy and in combination with other medications such as nivolumab and relatlimab. The drug is currently in Phase 1/2 clinical trials to determine its safety profile and establish the recommended dosage for future studies. The exact mechanism of action and pharmaceutical classification are not yet publicly disclosed as the medication is still in the experimental phase.

  • Nivolumab

    A subcutaneously administered immunotherapy medication that belongs to the class of PD-1 inhibitors. It works by blocking the PD-1 protein on T cells, which helps the immune system recognize and attack cancer cells more effectively. The medication is approved for treating various types of advanced solid tumors and is being studied in combination with BMS-986482 to potentially enhance its anti-cancer effects.

  • Relatlimab

    A subcutaneously administered immunotherapy drug that targets the LAG-3 protein on immune cells. It is being studied in combination with nivolumab as a fixed-dose combination therapy for advanced solid tumors. The medication works by blocking immune checkpoint proteins, potentially helping the body's immune system to better fight cancer cells.

  • Bevacizumab

    An intravenously administered targeted therapy that belongs to the class of anti-angiogenic agents. It works by blocking the formation of new blood vessels that feed tumors by targeting vascular endothelial growth factor (VEGF). The medication is approved for treating various types of advanced cancers and is being studied in combination with BMS-986482 to potentially improve treatment outcomes.

Investigated diseases

Advanced Solid Tumors - A condition where abnormal cells form solid masses or tumors that have spread from their original location to other parts of the body. These tumors can develop in various organs such as the lungs, liver, bones, or brain. The tumors grow by invading nearby tissues and can spread through the bloodstream or lymphatic system. Advanced solid tumors are characterized by continued growth and expansion beyond the initial site. These types of tumors can affect multiple body systems and organs simultaneously.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-516602-28-00Protocol codeCA2360001Estimated enrolment90 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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