Randomized phase III study of 2 cisplatin-based chemoradiation regimens in locally advanced head and neck squamous cell carcinoma: Impact of changing disease epidemiology on contemporary trial design

Head & Neck ◽  
2014 ◽  
Vol 37 (11) ◽  
pp. 1583-1589 ◽  
Author(s):  
Cristina P. Rodriguez ◽  
David J. Adelstein ◽  
Lisa A. Rybicki ◽  
Panayiotis Savvides ◽  
Jerrold P. Saxton ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Trial Design ◽  
Locally Advanced ◽  
Phase Iii ◽  
Advanced Head ◽  
Disease Epidemiology ◽  
Phase Iii Study

scholarly journals Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412

2020 ◽  
Vol 16 (18) ◽  
pp. 1235-1243 ◽  
Author(s):  
Jean-Pascal Machiels ◽  
Yungan Tao ◽  
Barbara Burtness ◽  
Makoto Tahara ◽  
Lisa Licitra ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Treatment Guidelines ◽  
Locally Advanced ◽  
Neck Squamous Cell Carcinoma ◽  
Phase Iii ◽  
Advanced Head ◽  
Double Blind

Current treatment guidelines for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) recommend multimodal treatment, including chemoradiation therapy (CRT) or surgery followed by radiation, with or without chemotherapy. The immune checkpoint inhibitor pembrolizumab has previously demonstrated antitumor activity in recurrent and/or metastatic HNSCC in large Phase III trials. For patients with locally advanced disease, Phase Ib data on the use of pembrolizumab in combination with chemoradiation have shown the approach to be safe and feasible. We describe here the design and rationale for KEYNOTE-412, a randomized, double-blind, Phase III trial investigating pembrolizumab or placebo administered concurrently with CRT and as maintenance treatment in patients with locally advanced HNSCC. Clinical Trial Registration: NCT03040999 ( ClinicalTrials.gov ).

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