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Study of BMS-986449 and Nivolumab 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 people with advanced solid tumors, which are types of cancer that have spread and are difficult to treat. The study involves two treatments: BMS-986449, a new medication taken as a capsule, and nivolumab, also known by its code name BMS936558, which is given through an infusion into a vein. The purpose of the study is to understand how safe and tolerable these treatments are when used alone or together in patients with advanced cancer.

Participants in the study will receive either BMS-986449 by itself or in combination with nivolumab. The study will monitor how the body responds to these treatments and any side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study will help researchers learn more about how these treatments work in the body and their potential benefits for people with advanced cancer.

The trial will take place over a period of time, during which participants will have regular check-ups and tests to monitor their health and the effects of the treatments. The information gathered from this study will contribute to understanding the potential of BMS-986449 and nivolumab as treatment options for advanced solid tumors, providing valuable insights for future cancer therapies.

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

    Enrollment and initial assessment

    Upon joining the study, participants will undergo an initial assessment to confirm eligibility. This includes verifying age (18 years or older) and confirming the presence of an advanced, metastatic solid tumor.

    A tumor biopsy will be required unless it is medically not possible.

  2. Step 2

    Treatment phase 1: monotherapy

    Participants will receive BMS-986449 as a monotherapy. This medication is administered orally in the form of hard capsules.

    The objective is to evaluate the safety and tolerability of BMS-986449 alone.

  3. Step 3

    Treatment phase 2: combination therapy

    Participants will receive a combination of BMS-986449 and nivolumab. Nivolumab is administered intravenously as a solution for infusion.

    The goal is to assess the safety and tolerability of the combination therapy.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, participants will be monitored for any side effects or adverse events. This includes regular health check-ups and assessments.

    The study will track the incidence of dose-limiting toxicities and other adverse events.

  5. Step 5

    Completion and final assessment

    Upon completion of the treatment phases, a final assessment will be conducted to evaluate the overall health and response to the treatment.

    The study is expected to conclude by May 21, 2025.

Who can join the trial?

6 criteria

  • Participants must be **18 years of age or older**.
  • Participants must have a **confirmed diagnosis** of a locally advanced, unresectable, metastatic, or recurrent solid tumor. This means the cancer is in a stage that cannot be removed by surgery and may have spread to other parts of the body.
  • For Part 1A, participants can have any type of solid cancer. For Part 1B, only those with **non-small cell lung cancer (NSCLC)** can participate. For Part 1C, only those with **triple-negative breast cancer (TNBC)** can participate.
  • Participants must have already tried existing treatments that are known to help their condition, or they must be unable to receive these treatments due to ineffectiveness, ineligibility, or intolerance.
  • Participants must have **measurable disease** according to specific guidelines (RECIST v 1.1), which means the cancer can be measured in size to track changes during the study.
  • A **tumor biopsy** must be obtained from all participants unless it is not medically possible. A biopsy is a small sample of tissue taken from the tumor to study it more closely.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not reached the required age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who are pregnant or breastfeeding.
  • Patients who have another serious health condition that could interfere with the study.
  • Patients who are taking certain medications that could affect the study results.
  • Patients who have had a recent surgery or medical procedure that could affect the study.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who have a history of substance abuse or alcohol dependency.
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Investigated drugs

  • BMS-986449

    is an experimental medication being studied for its safety and tolerability in people with advanced solid tumors. It is taken orally and is being tested both on its own and in combination with another medication to see how well it works and how safe it is for patients.

  • Nivolumab

    is a medication used to help the immune system fight cancer. In this study, it is being combined with BMS-986449 to see if the combination is more effective in treating advanced solid tumors than using BMS-986449 alone.

What is already known about the treatment

  • BMS-986449

    This medication is administered orally and is currently being studied in clinical trials for its safety and tolerability in treating advanced solid tumors. It is not yet widely recognized in medical literature as it is still in the early phases of research. The main therapeutic indication for BMS-986449 is advanced, metastatic solid malignancies. Its mechanism of action involves targeting specific pathways in cancer cells to inhibit their growth and spread. BMS-986449 is classified under investigational cancer therapies.

  • Nivolumab

    This medication is administered through intravenous infusion and is well-established in medical literature as an immunotherapy for various cancers. It is used in combination with BMS-986449 in clinical trials to enhance treatment effects for advanced solid tumors. Nivolumab works by blocking a protein called PD-1 on immune cells, allowing the immune system to better attack cancer cells. It is classified as a checkpoint inhibitor in cancer treatment.

Investigated diseases

Advanced Metastatic Solid Malignancy – This condition refers to a type of cancer that has spread from its original site to other parts of the body, forming solid tumors. These tumors can develop in various organs and tissues, leading to a range of symptoms depending on their location and size. As the disease progresses, it can cause significant disruption to the normal function of affected organs. The spread of cancer cells, known as metastasis, is a key characteristic of this condition, making it more challenging to manage. The progression of the disease often involves the growth of new tumors in distant organs, which can complicate the clinical picture. Understanding the behavior of these malignancies is crucial for developing effective treatment strategies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-503484-42-00Protocol codeCA120-1001Estimated enrolment98 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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).