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Clinical Trial Summary

The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).


Clinical Trial Description

This study is a prospective, multi-institutional, open-label, randomized phase II trial that will evaluate the efficacy of concurrent and adjuvant pembrolizumab with radiation therapy (RT) versus RT plus cisplatin in intermediate/high-riskp16-positive locoregionally advanced head and neck squamous cell carcinoma (HNSCC). The primary endpoint is progression-free survival (PFS). ;


Study Design


Related Conditions & MeSH terms

  • Cancer
  • Cancer of Head and Neck
  • Cancer, Advanced
  • Cancer, Metastatic
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Head and Neck Squamous Cell Carcinoma
  • Mouth Neoplasms
  • Neoplasm Metastasis
  • Oral Cancer
  • Oropharyngeal Cancer
  • Oropharyngeal Neoplasms
  • Oropharynx Cancer
  • Oropharynx Cancer, Metastatic
  • Oropharynx Cancer, Recurrent
  • Oropharynx Cancer, Stage III
  • Recurrence
  • Squamous Cell Carcinoma of Head and Neck
  • Tumor
  • Tumor Metastasis
  • Tumor Neck
  • Tumor Recurrence

NCT number NCT03383094
Study type Interventional
Source University of California, San Diego
Contact Loren Mell, MD
Phone (858) 246-0471
Email lmell@ucsd.edu
Status Recruiting
Phase Phase 2
Start date March 15, 2018
Completion date June 2025

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