A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)

Brief Summary:
Participants with recurrent or metastatic (R/M) squamous cell cancer of the head and neck (HNSCC) will be randomly assigned to receive pembrolizumab alone, or pembrolizumab + a platinum-based drug (cisplatin or carboplatin) + 5-Fluorouracil (5-FU), or cetuximab + a platinum-based drug (cisplatin or carboplatin) + 5-FU. The primary study hypothesis is that pembrolizumab or pembrolizumab in combination with chemotherapy prolongs progression free survival and overall survival compared to standard treatment.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Actual Study Start Date: March 19, 2015
Estimated Primary Completion Date: December 31, 2018
Estimated Study Completion Date: January 15, 2019

Arm:
- Experimental: Pembrolizumab
- Experimental: Pembrolizumab + Platinum + 5-FU
- Active Comparator: Cetuximab + Platinum + 5FU