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Study of BMS-986340, Nivolumab, and Docetaxel for Adults with Advanced or Metastatic Cancer

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 is focused on studying advanced or metastatic cancers, which are cancers that have spread to other parts of the body. The study involves testing a new treatment called BMS-986340, which is being evaluated both on its own and in combination with two other treatments: Nivolumab and Docetaxel. Nivolumab is a medication that helps the immune system fight cancer, while Docetaxel is a chemotherapy drug that works by stopping cancer cells from growing and dividing.

The purpose of the study is to assess the safety and tolerability of BMS-986340 and to determine the best dose to use when given alone or with the other medications. Participants in the study will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor how participants respond to the treatment and any side effects they may experience.

This trial is designed for adults aged 18 and older who have advanced or metastatic cancers, including types such as non-small cell lung cancer, head and neck cancer, gastric cancer, and others. The study will help researchers understand how well BMS-986340 works in treating these cancers and whether it can be safely combined with Nivolumab or Docetaxel.

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 and consent

    Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide your consent to participate.

    During this visit, a fresh tumor biopsy will be required for biomarker analysis. This is a procedure where a small sample of your tumor is taken for study purposes.

  2. Step 2

    Screening and eligibility

    You will undergo various tests to confirm your eligibility for the trial. These tests will include imaging studies to measure your disease and assess its progression.

    Your performance status will be evaluated to ensure you meet the criteria for participation. This involves assessing your ability to perform daily activities.

  3. Step 3

    Treatment phase

    The treatment phase involves receiving the study medications. You may receive BMS-986340 alone or in combination with nivolumab or docetaxel. All medications are administered through an intravenous infusion, which means they are given directly into your vein.

    The dosage and frequency of the medications will be determined by the study team based on the specific part of the trial you are participating in. The duration of this phase will depend on your response to the treatment and the study protocol.

  4. Step 4

    Regular monitoring

    Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies.

    You will be asked to report any side effects or changes in your condition. This information is crucial for assessing the safety and effectiveness of the treatment.

  5. Step 5

    Follow-up

    After completing the treatment phase, you will enter a follow-up period. During this time, the study team will continue to monitor your health and any long-term effects of the treatment.

    Follow-up visits will be scheduled at regular intervals as determined by the study protocol.

Who can join the trial?

8 criteria

  • Participants must be 18 years or older and have advanced or metastatic cancers. This means the cancer has spread to other parts of the body.
  • A fresh tumor sample must be provided before and during treatment for analysis. This is called a biopsy.
  • The disease must be measurable according to specific criteria, and there must be at least one tumor that can be biopsied.
  • Participants must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means they are fully active or have some symptoms but do not need bed rest during the day.
  • The disease must have shown progression on or after the most recent therapy, as seen in imaging tests.
  • Participants must have received standard treatments, including a type of drug known as a programmed death (ligand)-1 inhibitor, unless they are part of a specific group in the study.
  • Participants must have advanced or metastatic disease and have tried, not be suitable for, or cannot tolerate existing treatments that are known to help their condition.
  • Eligible cancer types include non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), gastric or gastroesophageal junction adenocarcinoma, ovarian cancer (OC), triple-negative breast cancer (TNBC), and others as specified in the study.

Who cannot join the trial?

15 criteria

  • Participants must not have any other serious health conditions that could interfere with the study.
  • Participants should not be pregnant or breastfeeding.
  • Participants must not have had another cancer treatment within a certain period before the study.
  • Participants should not have any known allergies to the study drugs.
  • Participants must not have any active infections that require treatment.
  • Participants should not have any significant heart problems.
  • Participants must not have any uncontrolled high blood pressure.
  • Participants should not have any history of severe lung disease.
  • Participants must not have any history of severe liver disease.
  • Participants should not have any history of severe kidney disease.
  • Participants must not have any history of severe neurological disorders, which are problems with the brain or nerves.
  • Participants should not have any history of autoimmune diseases, which are conditions where the immune system attacks the body.
  • Participants must not have participated in another clinical trial recently.
  • Participants should not have any mental health conditions that could interfere with the study.
  • Participants must not have any substance abuse issues, such as drug or alcohol abuse.
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Investigated drugs

  • BMS-986340

    is an experimental medication being tested to see how safe and tolerable it is for people with advanced solid tumors. This medication is being studied to find out the best dose that can be given safely, either by itself or when used with other treatments. The goal is to understand how it works in the body and if it can help treat cancer.

  • Nivolumab

    is a type of cancer treatment known as immunotherapy. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is being used in combination with BMS-986340 to see if the two medications together can improve treatment outcomes for people with advanced solid tumors.

  • Docetaxel

    is a chemotherapy drug that is used to treat various types of cancer. It works by stopping cancer cells from growing and dividing. In this study, docetaxel is combined with BMS-986340 to determine if this combination can be more effective in treating advanced solid tumors compared to using the medications separately.

What is already known about the treatment

BMS-986340 – BMS-986340 is an investigational medication currently being studied in clinical trials for its potential use in treating advanced or metastatic cancers in adults. It is administered as a monotherapy or in combination with other drugs like nivolumab or docetaxel, typically through intravenous infusion. The main goal of the trials is to evaluate its safety and determine the appropriate dosage levels. BMS-986340 is being explored for its ability to target and disrupt specific pathways in cancer cells, potentially slowing or stopping their growth. It falls under the category of experimental cancer therapies, and its exact mechanism of action is still under investigation.

Investigated diseases

Advanced Cancer – Advanced cancer refers to cancer that has spread from its original site to other parts of the body. This stage is also known as metastatic cancer. The progression involves the cancer cells breaking away from the primary tumor and traveling through the bloodstream or lymphatic system to form new tumors in other organs. As the disease progresses, it can affect the function of the organs involved, leading to various symptoms depending on the location of the metastases. The growth and spread of cancer cells can disrupt normal bodily functions and lead to a decline in overall health. The progression rate can vary significantly depending on the type of cancer and individual factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-503651-10-00Protocol codeCA052-002Estimated enrolment391 patientsSponsorBristol-Myers Squibb Services Unlimited Company

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