Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
122

Summary

Conditions
  • Cancer
  • Cancer of Head and Neck
  • Cancer, Advanced
  • Cancer Metastatic
  • Head and Neck Squamous Cell Carcinoma
  • Oral Cancer
  • Oropharyngeal Cancer
  • Tumor Recurrence
  • Oropharynx Cancer
  • Tumor
  • Oropharynx Cancer, Metastatic
  • Oropharynx Cancer, Recurrent
  • Oropharynx Cancer, Stage III
  • Tumor Neck
  • Tumor Metastasis
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 c...

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).

Tracking Information

NCT #
NCT03383094
Collaborators
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Loren Mell, MD University of California, San Diego