Nivolumab Trial for Advanced Solid Tumors, NSCLC Posts Safety Data

By Hipa.ai Research · March 18, 2025

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

Trial results for a Phase 1/2 study (NCT05543629) investigating BMS-986442 with nivolumab, with or without chemotherapy, in advanced solid tumors and non-small cell lung cancer were posted on ClinicalTrials.gov on 2025-03-18. The study was terminated and reported adverse event data across various treatment groups, with up to 8 participants experiencing adverse events in one group.

Background

Nivolumab is an intervention in this study, which investigated its combination with BMS-986442. The study focused on participants with advanced solid tumors and non-small cell lung cancer.

Trial design

The study (NCT05543629) was a Phase 1/2 trial designed to evaluate BMS-986442 in combination with nivolumab, with or without chemotherapy. It enrolled 36 participants with advanced solid tumors and non-small cell lung cancer. Interventions included bms-986442, nivolumab, docetaxel, carboplatin, and pemexetred. The trial was officially terminated.

Key results

The trial reported safety outcomes across different treatment groups. For the outcome of 'Number of Participants With Adverse Events':

In 'Part A: Treatment 1', 5 participants experienced adverse events.
In 'Part A: Treatment 2', 3 participants experienced adverse events.
In 'Part A: Treatment 3', 4 participants experienced adverse events.
In 'Part A: Treatment 4', 3 participants experienced adverse events.
In 'Part A: Treatment 5', 3 participants experienced adverse events.
In 'Part B1: Treatment 1', 7 participants experienced adverse events.
In 'Part B1: Treatment 2', 8 participants experienced adverse events.
In 'Part B2: Treatment 1', 3 participants experienced adverse events.

For the outcome of 'Number of Participants With Serious Adverse Events':

In 'Part A: Treatment 1', 3 participants experienced serious adverse events.
In 'Part A: Treatment 2', 0 participants experienced serious adverse events.
In 'Part A: Treatment 3', 4 participants experienced serious adverse events.
In 'Part A: Treatment 4', 2 participants experienced serious adverse events.

What this means

The posted results provide initial safety data for the investigational combination of BMS-986442 with nivolumab, with or without chemotherapy, in a small cohort of patients with advanced solid tumors and non-small cell lung cancer. As the study was terminated and primarily reports adverse event counts without efficacy data or detailed analyses, further conclusions regarding the combination's therapeutic potential cannot be drawn from these results alone.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05543629, titled 'A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer,' were posted on 2025-03-18 on clinicaltrials.gov.