CheckMate 141 — Nivolumab Versus Investigator's Choice in Recurrent or Metastatic Platinum-Refractory Head and Neck Squamous Cell Carcinoma

Phase 3 · 2016 · Head and Neck Cancer

Design

Randomized 2:1 to nivolumab vs investigator's choice of single-agent therapy (methotrexate, docetaxel, or cetuximab).

Population

Recurrent or metastatic head and neck squamous cell carcinoma that progressed within 6 months of platinum-based therapy.

Primary Endpoint

overall survival (OS)

Key Result

2-year update: OS 7.5 vs 5.1 mo (HR 0.70, P=0.0101); 2-yr OS 16.9% vs 6.0%, a durable survival plateau with fewer grade 3/4 toxicities.

Guideline Impact

NCCN category 1 second-line nivolumab for recurrent/metastatic HNSCC