Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Estimated Enrollment: 360
Study Start Date: May 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Arm A: Nivolumab
- Active Comparator: Arm B: Cetuximab/Methotrexate/Docetaxel