BMS-986525 Alone and with Nivolumab in Patients with Relapsed or Refractory Small Cell Lung Cancer

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Oncohelp Medical Center	Timisoara	Romania

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	25.05.2026
Romania	Not yet recruiting	25.05.2026
Spain	Not yet recruiting	25.05.2026

Trial locations

Investigated drugs:

Nivolumab

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.

Investigated diseases:

Small cell lung cancer

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 ID:

2025-524090-16-00

Protocol code:

CA258-0001

NCT ID:

NCT07325136

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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BMS-986525 Alone and with Nivolumab in Patients with Relapsed or Refractory Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?