Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412.
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Date
2020-06-03ICR Author
Author
Machiels, J-P
Tao, Y
Burtness, B
Tahara, M
Licitra, L
Rischin, D
Waldron, J
Simon, C
Gregoire, V
Harrington, K
Alves, GV
Figueiredo Lima, IP
Pointreau, Y
M Hughes, BG
Aksoy, S
Hetnal, M
Ge, JY
Brown, H
Cheng, J
Bidadi, B
Siu, LL
Type
Journal Article
Metadata
Show full item recordAbstract
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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Subject
Humans
Neoplasm Metastasis
Neoplasm Staging
Combined Modality Therapy
Antibodies, Monoclonal, Humanized
Chemoradiotherapy
Maintenance Chemotherapy
Antineoplastic Agents, Immunological
Squamous Cell Carcinoma of Head and Neck
Research team
Targeted Therapy
Targeted Therapy
Language
eng
Date accepted
2020-04-17
License start date
2020-06-03
Citation
Future oncology (London, England), 2020, 16 (18), pp. 1235 - 1243
Publisher
FUTURE MEDICINE LTD