18 and older, any sex, with Oral Cavity Carcinoma or Oral Intraepithelial Neoplasia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Oral Cancer-free SurvivalPrimary· 51.2 months
To determine oral cancer-free survival and overall survival of patients with high risk oral IEN treated with Pembrolizumab versus observation
Group
Value
95% CI
Arm A (Control)
NA
NA – NA
Arm B (Pembrolizumab )
6.7
3.6 – 40.2
Overall SurvivalSecondary· Overall survival was defined as from the randomization to death of all causes, whichever occurred first or last follow up.
To determine overall survival of patients with high risk oral IEN treated with pembrolizumab versus observation. The distribtuion of overall survival was estimated using Kaplan-Meier method.
Group
Value
95% CI
Arm A (Control)
NA
NA – NA
Arm B (Pembrolizumab).
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Approximately 4 years, 4 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This randomized phase II trial studies how well pembrolizumab works in treating patients with high risk oral intraepithelial neoplasia. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 23 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02882282.