| Literature DB >> 32490686 |
Jean-Pascal Machiels1, Yungan Tao2, Barbara Burtness3, Makoto Tahara4, Lisa Licitra5, Danny Rischin6, John Waldron7, Christian Simon8, Vincent Gregoire9, Kevin Harrington10, Gustavo Vasconcelos Alves11, Iane Pinto Figueiredo Lima12, Yoann Pointreau13, Brett G M Hughes14, Sercan Aksoy15, Marcin Hetnal16, Joy Y Ge17, Holly Brown17, Jonathan Cheng17, Behzad Bidadi17, Lillian L Siu18.
Abstract
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).Entities:
Keywords: PD-1; PD-L1; chemoradiation; head and neck cancer; immune checkpoint blockade; pembrolizumab
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Year: 2020 PMID： 32490686 DOI： 10.2217/fon-2020-0184
Source DB: PubMed Journal: Future Oncol ISSN： 1479-6694 Impact factor: 3.404