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Study of BMS-986408 Alone or with Nivolumab and Ipilimumab for Patients with Advanced Solid Tumors

Fast replyRegistered 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 advanced solid tumors, which are types of cancer that have spread and are difficult to remove surgically. The study involves testing a new medication called BMS-986408, which is taken as a tablet. This medication will be tested alone and in combination with two other drugs, Nivolumab and Ipilimumab. Nivolumab and Ipilimumab are given through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to understand how safe and tolerable these treatments are for patients with advanced cancer. The study will also determine the best dose and schedule for taking BMS-986408, both by itself and when combined with Nivolumab or with both Nivolumab and Ipilimumab. Participants will receive the treatments and be monitored for any side effects or reactions. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

Throughout the study, researchers will collect information on how the body processes BMS-986408 and how effective the treatments are in managing the cancer. The study aims to provide valuable insights into new treatment options for people with advanced solid tumors, potentially leading to better outcomes in the future.

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 visit

    Upon joining the study, you will have an initial visit where the medical team will review your medical history and perform necessary tests to confirm your eligibility.

    You will receive detailed information about the study, including the medications involved and their potential side effects.

  2. Step 2

    Treatment phase 1

    In the first phase of treatment, you may receive BMS-986408 as a monotherapy. This medication is taken orally in the form of a film-coated tablet.

    The dosage and frequency will be determined by the medical team based on your specific condition and response to the treatment.

  3. Step 3

    Combination treatment

    If you are part of a group receiving combination therapy, you may receive BMS-986408 along with Nivolumab or both Nivolumab and Ipilimumab.

    Nivolumab and Ipilimumab are administered through an intravenous (IV) infusion, which means they are given directly into your bloodstream through a vein.

    The medical team will provide the schedule for these infusions, which may occur at regular intervals.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, you will have regular follow-up visits to monitor your health and the effects of the treatment.

    These visits may include physical exams, blood tests, and imaging studies to assess the progress of your condition.

  5. Step 5

    End of trial

    At the end of the trial, you will have a final visit where the medical team will evaluate your overall health and discuss the outcomes of the study.

    You will receive information on any further steps or treatments that may be necessary based on the results of the trial.

Who can join the trial?

6 criteria

  • Participants must be 18 years of age or older.
  • Participants in Groups A and B must have a confirmed diagnosis of advanced, unresectable, or metastatic solid cancer that can be measured using specific criteria. This means the cancer cannot be removed by surgery and has spread to other parts of the body.
  • Participants in Groups A and B must have tried existing treatments that are known to help their condition, but these treatments did not work, or they could not tolerate them, or they are not eligible for them.
  • Participants in Groups C, D, and E must have a confirmed diagnosis of advanced, unresectable, or metastatic cancer with specific types: head and neck cancer (HNSCC), non-small cell lung cancer (NSCLC), melanoma, or renal cell carcinoma (RCC).
  • Participants in Groups C, D, and E must have previously received treatments that include anti-PD-(L)1 or anti-CTLA-4 agents, which are types of immunotherapy drugs.
  • Participants in Groups C, D, and E must have tried existing treatments that are known to help their condition, but these treatments did not work, or they could not tolerate them, or they are not eligible for them.

Who cannot join the trial?

10 criteria

  • Patients who have not been diagnosed with advanced solid tumors cannot participate. Advanced solid tumors are a type of cancer that forms in solid organs or tissues and has progressed to a more severe stage.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
  • Patients who are not able to understand or comply with the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate. These conditions are not specified in the provided data.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or adverse reactions to the study drugs cannot participate.
  • Patients who are taking medications that might interfere with the study drugs cannot participate.
  • Patients who have a history of certain medical conditions, such as severe heart or lung disease, may not be eligible.
  • Patients who have an active infection or other serious illness cannot participate.
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Investigated drugs

  • BMS-986408

    is an experimental medication being tested to see how safe it is and how well it works for people with advanced cancer. In this study, it is given by itself to understand its effects on the body and to find the best way to use it.

  • Nivolumab

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

  • Ipilimumab

    is another medication that boosts the immune system to help it attack cancer cells. It works differently from Nivolumab but is also used to enhance the body's natural defenses against cancer. In this study, it is combined with other treatments to explore its effectiveness in treating advanced cancer.

What is already known about the treatment

BMS-986408 – BMS-986408 is an experimental medication currently being studied for its potential use in treating advanced solid tumors. It is administered orally, either on its own or in combination with other drugs like nivolumab and ipilimumab. The main goal of the ongoing clinical trial is to determine the safety, tolerability, and optimal dosing schedule of BMS-986408. This medication is part of a class of drugs that aim to enhance the body's immune response against cancer cells, although its exact mechanism at the molecular level is still under investigation.

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 the disease progresses, the tumors may grow larger and spread to nearby tissues or distant organs, a process known as metastasis. The progression of advanced solid tumors often involves the invasion of surrounding structures and the potential to impair the function of affected organs. Symptoms can vary widely depending on the location and size of the tumor, potentially leading to pain, obstruction, or other organ-specific issues. The disease's progression is typically monitored through imaging studies and clinical evaluations.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-500823-61-00Protocol codeCA099-003Estimated enrolment136 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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