Pembrolizumab in Treating Patients With High Risk Oral Intraepithelial Neoplasia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02882282
Phase
PHASE2
Status
Completed

Conditions

  • Oral Cavity Carcinoma
  • Oral Intraepithelial Neoplasia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Patient Observation — OTHER
    Undergo observation
  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jun 14, 2017
Status verified
Aug 2025
Primary completion
Jul 14, 2025
Completion
Jul 14, 2025

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (observation)
    Patients undergo observation.
  • Experimental: Arm B (pembrolizumab)
    Patients receive pembrolizumab 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.

Primary Outcome Measure

Oral Cancer-free Survival [ Time Frame: 51.2 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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