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BMS-986525 Alone and with Nivolumab in Patients with Relapsed or Refractory Small Cell Lung 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 being done in Small Cell Lung Cancer that has come back after treatment or has not responded to treatment. The study is testing BMS-986525 alone and together with nivolumab, a medicine given by vein, to see whether these treatments are safe, how well they are tolerated, and what dose may be used for later studies.

The study will likely begin with small groups of people receiving BMS-986525 by intravenous infusion, either by itself or with nivolumab. The treatment is given over time, and the study team watches for side effects and other changes while treatment continues. The purpose of the study is to find the best dose for further testing and to learn how the medicines behave in the body.

Relapsed means the cancer has returned after treatment, and refractory means it has not improved with treatment. Small Cell Lung Cancer is a fast-growing type of lung cancer. This study is focused on learning more about the safety of BMS-986525 with and without nivolumab in this disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study treatment begins

    After joining the study, you receive BMS-986525 as an intravenous infusion. An intravenous infusion means the medicine is given through a vein.

    The study tests BMS-986525 by itself and also in combination with nivolumab. Nivolumab is also given by intravenous infusion.

    The exact dose of either medicine is not stated in the source data. The study is designed to find the recommended dose and the highest dose that can be given without causing severe side effects.

  2. Step 2

    Treatment period and repeated dosing

    You continue receiving the study medicine during the trial according to the study plan. The source data does not state the exact frequency or duration of each infusion.

    The trial includes treatment with BMS-986525 alone and treatment with BMS-986525 plus nivolumab.

    The study team checks how the medicines act in your body and whether the cancer changes during treatment.

  3. Step 3

    Safety checks during the trial

    During the trial, you are monitored for side effects. Side effects are unwanted effects of treatment.

    The main safety check is to record the type, frequency, and severity of side effects.

    This part of the trial is used to see whether the treatment is safe and well tolerated.

  4. Step 4

    Response and body handling assessments

    The trial also measures how BMS-986525 behaves in your body when given alone and when given with nivolumab.

    The trial checks how your disease responds to BMS-986525 alone and to the combination with nivolumab.

    These assessments are used to learn whether the treatment helps control relapsed or refractory small cell lung cancer. Relapsed means the cancer came back after treatment. Refractory means the cancer did not respond well to treatment.

Who can join the trial?

4 criteria

  • Have small cell lung cancer that has come back after previous treatment (relapsed) or is not responding to current treatment (refractory).
  • Have received at least 1 platinum-based chemotherapy treatment. Chemotherapy means cancer medicine, and platinum-based means it contains a platinum drug such as cisplatin or carboplatin.
  • If the usual first treatment in the country includes platinum-based chemotherapy plus anti-PD-(L)1 therapy, the participant must meet one of these: have tried anti-PD-(L)1 therapy and not responded, be unable to receive it, or not have access to it. Anti-PD-(L)1 therapy is a type of immunotherapy, which helps the immune system attack cancer.
  • Have adequate organ function, meaning the main organs such as the liver, kidneys, and bone marrow are working well enough for study treatment.

Who cannot join the trial?

3 criteria

  • Cannot have untreated central nervous system (CNS) involvement of small cell lung cancer. The central nervous system means the brain and spinal cord.
  • Cannot have active, known, or suspected autoimmune disease. An autoimmune disease is a condition in which the body's immune system attacks its own healthy tissues.
  • Cannot have previously received an organ or tissue transplant from another person.
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Investigated drugs

  • BMS-986525

    is an experimental medicine given by intravenous infusion, which means it is put directly into a vein through a drip. In this study, it is being tested by itself to see if it is safe, how well people can tolerate it, and what dose should be used for future studies. It is being studied as a possible treatment for people with small cell lung cancer that has come back or has not responded well to previous treatment.

  • Nivolumab

    is an immunotherapy medicine given by intravenous infusion. It helps the body’s own immune system recognize and attack cancer cells. In this trial, nivolumab is being tested together with BMS-986525 to see whether the combination is safe, how well it works, and what dose may be best for further study in people with relapsed or hard-to-treat small cell lung cancer.

What is already known about the treatment

  • BMS-986525

    BMS-986525 is given as a solution for intravenous infusion, meaning it is delivered slowly through a vein by a healthcare professional. It is an experimental medicine in clinical research, so its full role in everyday medical practice is not yet established, but it is being studied as a possible cancer treatment. Its main use in this trial is for relapsed or hard-to-treat small cell lung cancer, either alone or with nivolumab. At the molecular level, it is designed to affect immune signals that can help the body’s defenses better recognize and attack cancer cells, and it belongs to the group of experimental immunotherapy medicines.

  • Nivolumab

    Nivolumab is also given as a solution for intravenous infusion, so it is administered through a vein by a trained medical team. It is an approved medicine and is well described in medical literature as a cancer immunotherapy drug. It is used for several cancers, including lung cancer, because it helps the immune system fight tumor cells. Nivolumab works by blocking a protein called PD-1 on immune cells, which removes a “brake” on the immune response, and it is classified as a monoclonal antibody and immune checkpoint inhibitor.

Investigated diseases

Relapsed/Refractory Small Cell Lung Cancer - A type of small cell lung cancer that has come back after treatment or has not responded to treatment. It usually develops quickly and can spread early to other parts of the body. Over time, the disease may continue to grow despite previous therapy and become harder to control.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-524090-16-00Protocol codeCA258-0001Estimated enrolment42 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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