Trial results for nivolumab as a novel neoadjuvant pre-surgical therapy for locally advanced oral cavity cancer were posted on ClinicalTrials.gov on 2025-11-12. The Phase 2 study (NCT03021993) reported that 4 participants achieved an objective response rate based on pathological response.
Background
The study investigated nivolumab for patients with oral cavity cancer (OCC) who were scheduled to undergo surgery. It aimed to assess the effectiveness of this immunotherapy in a neoadjuvant setting for Oral Cavity SCC.
Trial design
The study, identified as NCT03021993, was a Phase 2 trial titled "Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer." It was a completed study that enrolled 17 participants with Oral Cavity SCC. The trial investigated nivolumab as a neoadjuvant intervention before surgery. The primary outcomes were not explicitly detailed in the provided data, but key measurements were reported for the nivolumab treatment arm.
Key results
The trial reported several key measurements for the nivolumab group:
- Objective Response Rate Using Pathological Response: 4 Participants.
- Level of Treg Cells in Peripheral Blood Using Immunostaining: Mean of 7.7 percentage of treg cells (Standard Deviation: 8.4).
- Level of Treg Cells in Peripheral Blood Using Immunostaining: Mean of 9.2 percentage of treg cells (Standard Deviation: 9.1).
- Level of Activated T-cells in Peripheral Blood: Mean of 58 percentage of CD8 IFN gamma T-cells (Standard Deviation: 0.49).
- Level of Activated T-cells in Peripheral Blood: Mean of 62.2 percentage of CD8 IFN gamma T-cells (Standard Deviation: 0.48).
- Level of Immune Stimulatory Cytokines in Peripheral Blood: Mean of 26.4 percentage of cytokines (Standard Deviation: 0.19).
- Level of Immune Stimulatory Cytokines in Peripheral Blood: Mean of 36.7 percentage of cytokines (Standard Deviation: 0.48).
- Expression of IFN-gamma in CD4+ Cells: Mean of 20 percentage of CD4 positive cells (Standard Deviation: 12.6).
- Expression of IFN-gamma in CD4+ Cells: Mean of 23.9 percentage of CD4 positive cells (Standard Deviation: 13.5).
- Expression of Granzyme-B in CD8+ Cells From Peripheral Blood: Mean of 46.7 percentage of CD8 positive cells (Standard Deviation: 15.8).
- Expression of Granzyme-B in CD8+ Cells From Peripheral Blood: Mean of 55.5 percentage of CD8 positive cells (Standard Deviation: 15.7).
- Expression of CD8+ Cells Expressing Granzyme B (Cytolytic Response) From Peripheral Blood: Mean of 34.7 percentage of CD8+cells expressing granz (Standard Deviation: 0.48).
What this means
The results from this Phase 2 trial provide initial data on the use of nivolumab as a neoadjuvant therapy for locally advanced oral cavity cancer. The observation of 4 participants achieving an objective pathological response suggests potential activity in this setting. The reported biomarker levels, including Treg cells, activated T-cells, immune stimulatory cytokines, IFN-gamma, and Granzyme-B expression, offer insights into the immunological changes associated with nivolumab treatment in this patient population. Further research would be needed to fully understand the clinical significance of these findings.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03021993, titled "Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer," were posted on 2025-11-12 on clinicaltrials.gov.