Nivolumab Shows Improvement in Bronchial Dysplasia in High-Risk Smokers

Trial results for nivolumab (NCT03347838) for the reversal of squamous dysplasia in high-risk current and former smokers were posted on ClinicalTrials.gov on 2025-12-12. The study observed an improvement in endobronchial histology in 10 participants, with an observed response rate of 0.526 (p-value: 0.03).

Background

Nivolumab is a PD-1 inhibitor. This study aimed to determine whether nivolumab improves premalignant bronchial dysplastic lesions in subjects at high risk for the development of lung cancer, including those with a prior smoking history, or a history of lung cancer or head and neck cancer.

Trial design

The study (NCT03347838) was a Phase 2 clinical research study that enrolled 19 participants. It investigated nivolumab in individuals with bronchial dysplasia, tobacco smoking history, a history of non-small cell lung cancer, or a history of head and neck cancer. The study's goal was to assess if nivolumab could improve premalignant bronchial dysplastic lesions and to evaluate its safety and tolerability.

Key results

For the outcome of "Improvement in Endobronchial Histology" in the Nivolumab Injection [Opdivo] group, 10 participants showed improvement. An analysis using the Fisher Exact method for the "Observed response rate" yielded a value of 0.526, with a 95.0% confidence interval ranging from 0.32 to 1.0. The p-value for this analysis was 0.03. The null hypothesis for this analysis was that the 6-month response rate is less than or equal to 0.3.

What this means

The results suggest that nivolumab may have a positive effect on improving premalignant bronchial dysplastic lesions in high-risk current and former smokers. The observed response rate of 0.526, coupled with a statistically significant p-value of 0.03, indicates that nivolumab could be a potential therapeutic option for reversing squamous dysplasia in this patient population, exceeding the threshold set by the null hypothesis.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03347838, titled "Nivolumab for the Reversal of Squamous Dysplasia in High Risk Current and Former Smokers," were posted on 2025-12-12 on clinicaltrials.gov.