Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412.
| Title: | Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. |
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| Authors: | Machiels JP; Department of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint-Luc & Institut de Recherche Clinique et Expérimentale, Université Catholique de Louvain (UCLouvain), Avenue Hippocrate 10, Brussels, Belgium.; Tao Y; Department of Radiation Oncology, Gustave Roussy Cancer Campus, 114 Rue Edouard Vaillant, 94800, Villejuif, France.; Burtness B; Department of Medicine, Yale University School of Medicine & Yale Cancer Center, 333 Cedar Street, New Haven, CT 06510, USA.; Tahara M; Department of Head & Neck Medical Oncology, National Cancer Center Hospital East, 6-Chome-5-1 Kashiwanoha, Kashiwa, Chiba, 27-8577, Japan.; Licitra L; Department of Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Via Giacomo Venezian 1, 20133, Milan, Italy.; Rischin D; Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia.; Waldron J; Department of Radiation Oncology University of Toronto, Princess Margaret Cancer Centre, 610 University Avenue, Toronto, ON, M5G 2M9, Canada.; Simon C; Department of Otorhinolaryngology, University Hospital CHUV, Rue du Bugnon 21, 1011, Lausanne, Switzerland.; Gregoire V; Department of Radiation Oncology, Centre Leon Berard, 28 Prom. Lea et Napoleon Bullukian, 69008, Lyon, France.; Harrington K; Division of Radiotherapy & Imaging, The Institute of Cancer Research, London, SW3 6JB, UK.; Alves GV; Centro Integardo de Pesquisa em Oncologia, Hospital Nossa Senhora da Conceição, Avenida Francisco Trein, 596 - Cristo Redentor Porto Alegre - RS, 91350-200, Brazil.; Figueiredo Lima IP; Crio Centro Regional Integrado de Oncologia, R. Francisco Calaca, 1300 - Alvaro Weyne, Fortaleza - CE, 60335-480, Brazil.; Pointreau Y; Department of Radiation Oncology, Institut Inter-Regional de Cancerologie-Centre Jean Bernard/Clinique Victor Hugo, 72000, Le Mans, France.; M Hughes BG; Cancer Care Services, Royal Brisbane & Women's Hospital, Butterfield Street, Herston QLD 4029, Australia & School of Medicine, University of Queensland, 20 Weightman Street, Herston, QLD, 4006, Australia.; Aksoy S; Hacettepe University, Cancer Institute, Department of Medical Oncology, 06100, Ankara, Turkey.; Hetnal M; Faculty of Medicine & Health Sciences, Andrzej Frycz Modrzewski Krakow University, Amethyst Radiotherapy Centre, Rydygier Hospital, Krakow, Poland, Złotej Jesieni 1, Krakow, Poland.; Ge JY; Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.; Brown H; Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.; Cheng J; Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.; Bidadi B; Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.; Siu LL; Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. |
| Source: | Future oncology (London, England) [Future Oncol] 2020 Jun; Vol. 16 (18), pp. 1235-1243. Date of Electronic Publication: 2020 Jun 03. |
| Publication Type: | Clinical Trial Protocol; Journal Article |
| Language: | English |
| Journal Info: | Publisher: Taylor & Francis Country of Publication: England NLM ID: 101256629 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1744-8301 (Electronic) Linking ISSN: 14796694 NLM ISO Abbreviation: Future Oncol Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2024- : [Milton Park, Oxfordshire] : Taylor & Francis; Original Publication: London : Future Medicine Ltd., c2005- |
| MeSH Terms: | Antibodies, Monoclonal, Humanized*/administration & dosage ; Antibodies, Monoclonal, Humanized*/adverse effects ; Antibodies, Monoclonal, Humanized*/therapeutic use ; Antineoplastic Agents, Immunological*/administration & dosage ; Antineoplastic Agents, Immunological*/adverse effects ; Antineoplastic Agents, Immunological*/therapeutic use ; Squamous Cell Carcinoma of Head and Neck*/pathology ; Squamous Cell Carcinoma of Head and Neck*/therapy; Combined Modality Therapy/adverse effects ; Combined Modality Therapy/methods ; Humans ; Chemoradiotherapy ; Maintenance Chemotherapy ; Neoplasm Metastasis ; Neoplasm Staging ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase III as Topic |
| 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). |
| Grant Information: | 28724 United Kingdom CRUK_ Cancer Research UK |
| Contributed Indexing: | Keywords: PD-1; PD-L1; chemoradiation; head and neck cancer; immune checkpoint blockade; pembrolizumab |
| Molecular Sequence: | ClinicalTrials.gov NCT03040999 |
| Substance Nomenclature: | 0 (Antibodies, Monoclonal, Humanized); 0 (Antineoplastic Agents, Immunological); DPT0O3T46P (pembrolizumab) |
| Entry Date(s): | Date Created: 20200604 Date Completed: 20210208 Latest Revision: 20250530 |
| Update Code: | 20260130 |
| DOI: | 10.2217/fon-2020-0184 |
| PMID: | 32490686 |
| Database: | MEDLINE |
Clinical Trial Protocol; Journal Article