Trial results for pembrolizumab (Keytruda) in patients with high risk oral intraepithelial neoplasia were posted on ClinicalTrials.gov on 2025-10-23. The study, NCT02882282, reported a median oral cancer-free survival of 6.7 months for the pembrolizumab treatment arm.
Background
Pembrolizumab is an immunotherapy drug. The trial investigated its use in patients with high risk oral intraepithelial neoplasia, a condition that can precede oral cavity carcinoma. Immunotherapy with monoclonal antibodies like pembrolizumab is designed to help the body's immune system target and attack cancer cells, potentially inhibiting their growth and spread.
Trial design
The study, NCT02882282, was a Phase 2 randomized trial evaluating pembrolizumab in patients with high risk oral intraepithelial neoplasia and oral cavity carcinoma. The trial enrolled 15 participants. Interventions included pembrolizumab, with a control arm (Arm A) and a pembrolizumab treatment arm (Arm B).
Key results
The trial reported outcomes for oral cancer-free survival and overall survival. For the outcome of "Oral Cancer-free Survival":
- In the control arm (Arm A), the median oral cancer-free survival was NA months.
- In the pembrolizumab treatment arm (Arm B), the median oral cancer-free survival was 6.7 months.
For the outcome of "Overall Survival":
- In the control arm (Arm A), the median overall survival was NA months.
- In the pembrolizumab treatment arm (Arm B), the median overall survival was NA months.
What this means
These Phase 2 trial results provide initial data on the use of pembrolizumab in patients with high risk oral intraepithelial neoplasia. The finding of a median oral cancer-free survival of 6.7 months in the pembrolizumab arm offers an early indication of potential activity in this patient population. However, the absence of a reported median for the control arm and for overall survival in both arms limits direct comparative conclusions from this specific data set. Further research would be needed to fully understand the clinical benefit of pembrolizumab for this condition.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02882282, titled "Pembrolizumab in Treating Patients With High Risk Oral Intraepithelial Neoplasia," were posted on 2025-10-23 on clinicaltrials.gov.