Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412
Jean-Pascal Machiels, Yungan Tao, Barbara Burtness, Makoto Tahara, Lisa Licitra, Danny Rischin, John Waldron, Christian Simon, Vincent Gregoire, Kevin Harrington, Gustavo Vasconcelos Alves, Iane Pinto Figueiredo Lima, Yoann Pointreau, Brett G M Hughes, Sercan Aksoy, Marcin Hetnal, Joy Y Ge, Holly Brown, Jonathan Cheng, Behzad Bidadi, Lillian L Siu, Jean-Pascal Machiels, Yungan Tao, Barbara Burtness, Makoto Tahara, Lisa Licitra, Danny Rischin, John Waldron, Christian Simon, Vincent Gregoire, Kevin Harrington, Gustavo Vasconcelos Alves, Iane Pinto Figueiredo Lima, Yoann Pointreau, Brett G M Hughes, Sercan Aksoy, Marcin Hetnal, Joy Y Ge, Holly Brown, Jonathan Cheng, Behzad Bidadi, Lillian L Siu
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).
Keywords: PD-1; PD-L1; chemoradiation; head and neck cancer; immune checkpoint blockade; pembrolizumab.
Source: PubMed