In short
BMS-986525 is an investigational immunotherapy being studied in a Phase 1/2 clinical trial for people with relapsed or refractory small cell lung cancer (SCLC). The trial (NCT07325136) is currently authorised and plans to enroll 42 participants. It is testing BMS-986525 both alone and in combination with nivolumab, a medicine that helps the immune system attack cancer cells.
Key points
- BMS-986525 is an investigational immunotherapy being studied in a Phase 1/2 trial.
- The trial focuses on relapsed or refractory small cell lung cancer (SCLC).
- 42 participants are planned for enrollment in the study.
- BMS-986525 is given by intravenous infusion, both alone and with nivolumab.
- The main goal is to assess safety and tolerability and find the highest dose that does not cause severe side effects.
- The trial is currently authorised but not yet recruiting.
What is BMS-986525?
BMS-986525 is an investigational substance being developed as a potential treatment for cancer. It is currently being studied in a Phase 1/2 clinical trial for people with relapsed or refractory small cell lung cancer (SCLC). The substance is given by intravenous infusion, which means it is delivered directly into a vein. At this stage, BMS-986525 does not have a marketing authorisation, meaning it is not yet approved as a medicine for use outside clinical trials.
How does BMS-986525 work?
The trial record does not provide a detailed description of the mechanism of action of BMS-986525. The study is designed to test whether BMS-986525, alone or in combination with nivolumab, is safe and well-tolerated in patients with relapsed or refractory SCLC. Nivolumab is a type of immunotherapy known as an immune checkpoint inhibitor, which works by helping the immune system recognise and attack cancer cells. The combination of BMS-986525 with nivolumab is being explored to understand whether the two substances can work together safely.
Which conditions is BMS-986525 being studied for?
- Relapsed or refractory small cell lung cancer (SCLC): Small cell lung cancer is a fast-growing type of lung cancer. Relapsed means the cancer has returned after previous treatment, and refractory means it did not respond to previous treatment.
How is BMS-986525 given?
BMS-986525 is given as an intravenous infusion, meaning it is delivered directly into a vein over a period of time. In this trial, it is being tested both on its own and in combination with nivolumab, which is also given by intravenous use. The trial does not report a specific dose for BMS-986525, as one of the main goals is to determine the highest dose that can be given without causing severe side effects.
What do the clinical trials show?
There is currently one clinical trial of BMS-986525 registered, with the identifier NCT07325136. It is a Phase 1/2 study, meaning it is an early-stage trial that first tests safety in a small number of people and then begins to look at how well the treatment works. The trial is authorised, which means it has received approval to begin, but it is not yet recruiting participants. The planned enrollment is 42 participants. Because the trial has not yet reported results, there are no findings yet about how effective BMS-986525 is.
Who can take part in these trials?
The trial is open to people with relapsed or refractory small cell lung cancer. This means participants have already received at least one prior treatment for their cancer, and the cancer has either come back or did not respond to that treatment. The trial does not list additional eligibility criteria in the available registry data.
What are the trials measuring?
The primary outcome of the trial is the type, frequency, and severity of side effects. This is a measure of safety and tolerability. The trial also aims to determine the recommended dose for further testing, specifically the highest dose of BMS-986525 that can be given without causing severe side effects. These are typical goals for an early-phase trial, where the main question is whether a new treatment is safe enough to move on to larger studies.
What side effects are known?
Because BMS-986525 is still in early clinical development, the full range of side effects is not yet known. The main purpose of the current trial is to identify the side effects that occur and how severe they are. The registry record does not list specific side effects that have been observed so far.