NCT02882282

Pembrolizumab in Treating Patients With High Risk Oral Intraepithelial Neoplasia

Personalized, Randomized, Phase 2 Study of Pembrolizumab (MK-3475) for High Risk Oral Intra-Epithelial Neoplasias

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine oral cancer-free survival of patients with high risk oral intra-epithelial neoplasias (IEN) treated with pembrolizumab versus observation. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of pembrolizumab for patients with oral IEN. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo observation. ARM B: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6, 9, 12, 18, 24, 30, and 36 months and then periodically thereafter.

Conditions

• Oral Cavity Carcinoma
• Oral Intraepithelial Neoplasia

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Patient Observation	Undergo observation
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2017-06-14
• Primary completion: 2025-07-14
• Completion: 2025-07-14
• First posted: 2016-08-29
• Last updated: 2025-10-23
• Results posted: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study