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Study of BMS-986253 with Nivolumab and Ipilimumab for Patients with Advanced Solid Tumors

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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 patients with advanced cancers, specifically those with advanced solid tumors. The study involves the use of an experimental medication called BMS-986253, which is being tested in combination with other medications, namely Nivolumab and Ipilimumab. These medications are administered as a solution through an intravenous infusion, which means they are given directly into the bloodstream through a vein.

The purpose of the study is to explore the safety and effectiveness of these combinations in treating advanced cancers. The study is divided into two parts. In the first part, the focus is on understanding how safe and tolerable the combination of BMS-986253 with Nivolumab, or with both Nivolumab and Ipilimumab, is for patients. The second part of the study aims to compare the effects of the combination of BMS-986253, Nivolumab, and Ipilimumab with a placebo plus Nivolumab and Ipilimumab in patients with advanced melanoma, a type of skin cancer, who have a specific level of a protein called IL-8 in their blood.

Throughout the study, participants will receive the treatments and be monitored for any side effects or changes in their condition. The study will help determine the best dose of BMS-986253 when used with these other medications and will provide valuable information on how these treatments can help manage advanced cancers. The study is expected to continue until mid-2025, providing insights into the potential benefits and risks of these treatment combinations for patients with advanced cancers.

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 verifying the presence of at least one lesion accessible for biopsy and an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

  2. Step 2

    Treatment phase 1

    In the first part of the treatment, the focus is on evaluating the safety and tolerability of the medications. The medications used include nivolumab and ipilimumab, both administered intravenously as a solution for infusion.

    The dosage and frequency are determined based on the specific protocol of the study. The goal is to identify any dose-limiting toxicities and establish the recommended dose for further study.

  3. Step 3

    Treatment phase 2

    In the second part of the treatment, the effectiveness of the medication combination is compared to a placebo. This phase involves the use of BMS-986253 in combination with nivolumab and ipilimumab.

    The objective is to assess progression-free survival in patients with advanced melanoma and specific serum levels of IL-8.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to track any adverse events, serious adverse events, and any changes in clinical laboratory results.

    The study also evaluates the progression-free survival and overall survival of participants, using specific criteria to assess the response to treatment.

  5. Step 5

    Completion and analysis

    Upon completion of the trial, data is analyzed to determine the overall safety and effectiveness of the treatment. This includes reviewing the incidence of adverse events and the overall survival rates of participants.

Who can join the trial?

7 criteria

  • Participants must have **advanced solid tumors**. This means the cancer has spread and is not limited to one area.
  • Participants need to have at least one **lesion** that can be accessed for a **biopsy**. A lesion is an area of abnormal tissue, and a biopsy is a procedure to take a small sample of tissue for testing.
  • Participants should have an **Eastern Cooperative Oncology Group Performance Status** of 0 or 1. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Participants with **non-small cell lung carcinoma** (a type of lung cancer) are eligible only for specific parts of the study.
  • Participants must be within certain age ranges, which are typically defined in the study.
  • Both **male and female** participants are eligible to join the study.
  • The study may include individuals from **vulnerable populations**, which means people who might need special protection or consideration.

Who cannot join the trial?

8 criteria

  • Patients who have not fully recovered from previous treatments or surgeries.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with known allergies to the study medications.
  • Patients with certain infections that are not well controlled.
  • Patients with a history of certain heart conditions.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

  • BMS-986253

    is an experimental medication being studied for its potential to treat advanced cancers. It is being tested to see how safe and tolerable it is when used in combination with other cancer treatments. Researchers are also trying to find the best dose to use in future studies.

  • Nivolumab

    is a medication used to help the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. In this study, it is being used in combination with other treatments to see if it can improve outcomes for patients with advanced cancers.

  • Ipilimumab

    is another medication that helps the immune system attack cancer cells. It works by targeting a different protein than nivolumab, and it is often used in combination with other treatments to enhance the immune response against cancer. In this trial, it is being combined with nivolumab and BMS-986253 to evaluate its effectiveness in treating advanced cancers.

What is already known about the treatment

  • BMS-986253

    This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating advanced solid tumors. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for BMS-986253 is in combination with other drugs for advanced cancers, particularly melanoma. At the molecular level, it works by targeting specific pathways involved in tumor growth and immune response. It is classified as an investigational drug in the field of oncology.

  • Nivolumab

    This medication is given as an intravenous infusion and is approved for use in various types of cancer, including melanoma, lung cancer, and kidney cancer. It is well-documented in medical literature as an immune checkpoint inhibitor. Nivolumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as an immunotherapy drug.

  • Ipilimumab

    Administered through intravenous infusion, this medication is approved for the treatment of melanoma and is being studied for other cancers. It is widely recognized in medical literature as an immune checkpoint inhibitor. Ipilimumab enhances the immune system's ability to fight cancer by targeting the CTLA-4 pathway. It is classified as an immunotherapy drug.

Investigated diseases

Advanced Solid Tumors – Advanced solid tumors refer to a group of cancers that originate in solid organs or tissues and have progressed to a more severe stage. These tumors can occur in various parts of the body, such as the lungs, liver, pancreas, or colon. As they advance, they may grow larger, invade nearby tissues, and potentially spread to other parts of the body. The progression of these tumors can lead to a range of symptoms depending on their location and size, such as pain, swelling, or organ dysfunction. The complexity of advanced solid tumors often requires comprehensive management to address the challenges they present.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509061-20-00Protocol codeCA027-002Estimated enrolment590 patientsSponsorBristol Myers Squibb International Corporation

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