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KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma

Despite curative-intent treatment, most patients with locally advanced esophageal cancer will experience disease recurrence or locoregional progression, highlighting the need for new therapies. Current guidelines recommend definitive chemoradiotherapy in patients ineligible for surgical resection, b...

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Autores principales: Shah, Manish A, Bennouna, Jaafar, Doi, Toshihiko, Shen, Lin, Kato, Ken, Adenis, Antoine, Mamon, Harvey J, Moehler, Markus, Fu, Xiaolong, Cho, Byoung Chul, Bordia, Sonal, Bhagia, Pooja, Shih, Chie-Schin, Desai, Anjali, Enzinger, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Future Medicine Ltd 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927908/
https://www.ncbi.nlm.nih.gov/pubmed/33533655
http://dx.doi.org/10.2217/fon-2020-0969
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author Shah, Manish A
Bennouna, Jaafar
Doi, Toshihiko
Shen, Lin
Kato, Ken
Adenis, Antoine
Mamon, Harvey J
Moehler, Markus
Fu, Xiaolong
Cho, Byoung Chul
Bordia, Sonal
Bhagia, Pooja
Shih, Chie-Schin
Desai, Anjali
Enzinger, Peter
author_facet Shah, Manish A
Bennouna, Jaafar
Doi, Toshihiko
Shen, Lin
Kato, Ken
Adenis, Antoine
Mamon, Harvey J
Moehler, Markus
Fu, Xiaolong
Cho, Byoung Chul
Bordia, Sonal
Bhagia, Pooja
Shih, Chie-Schin
Desai, Anjali
Enzinger, Peter
author_sort Shah, Manish A
collection PubMed
description Despite curative-intent treatment, most patients with locally advanced esophageal cancer will experience disease recurrence or locoregional progression, highlighting the need for new therapies. Current guidelines recommend definitive chemoradiotherapy in patients ineligible for surgical resection, but survival outcomes are poor. Pembrolizumab is well tolerated and provides promising antitumor activity in patients with previously treated, advanced, unresectable esophageal/esophagogastric junction cancer. Combining pembrolizumab with chemoradiotherapy may further improve outcomes in the first-line setting. Here, we describe the design and rationale for the double-blind, Phase III, placebo-controlled, randomized KEYNOTE-975 trial investigating pembrolizumab in combination with definitive chemoradiotherapy as first-line treatment in patients with locally advanced, unresectable esophageal/gastroesophageal junction cancer. Overall survival and event-free survival are the dual primary end points. Clinical trial registration: NCT04210115 (ClinicalTrials.gov)
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spelling pubmed-79279082021-03-10 KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma Shah, Manish A Bennouna, Jaafar Doi, Toshihiko Shen, Lin Kato, Ken Adenis, Antoine Mamon, Harvey J Moehler, Markus Fu, Xiaolong Cho, Byoung Chul Bordia, Sonal Bhagia, Pooja Shih, Chie-Schin Desai, Anjali Enzinger, Peter Future Oncol Clinical Trial Protocol Despite curative-intent treatment, most patients with locally advanced esophageal cancer will experience disease recurrence or locoregional progression, highlighting the need for new therapies. Current guidelines recommend definitive chemoradiotherapy in patients ineligible for surgical resection, but survival outcomes are poor. Pembrolizumab is well tolerated and provides promising antitumor activity in patients with previously treated, advanced, unresectable esophageal/esophagogastric junction cancer. Combining pembrolizumab with chemoradiotherapy may further improve outcomes in the first-line setting. Here, we describe the design and rationale for the double-blind, Phase III, placebo-controlled, randomized KEYNOTE-975 trial investigating pembrolizumab in combination with definitive chemoradiotherapy as first-line treatment in patients with locally advanced, unresectable esophageal/gastroesophageal junction cancer. Overall survival and event-free survival are the dual primary end points. Clinical trial registration: NCT04210115 (ClinicalTrials.gov) Future Medicine Ltd 2021-02-03 2021-04 /pmc/articles/PMC7927908/ /pubmed/33533655 http://dx.doi.org/10.2217/fon-2020-0969 Text en © 2021 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License (http://creativecommons.org/licenses/by-nc-nd/4.0/)
spellingShingle Clinical Trial Protocol
Shah, Manish A
Bennouna, Jaafar
Doi, Toshihiko
Shen, Lin
Kato, Ken
Adenis, Antoine
Mamon, Harvey J
Moehler, Markus
Fu, Xiaolong
Cho, Byoung Chul
Bordia, Sonal
Bhagia, Pooja
Shih, Chie-Schin
Desai, Anjali
Enzinger, Peter
KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma
title KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma
title_full KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma
title_fullStr KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma
title_full_unstemmed KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma
title_short KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma
title_sort keynote-975 study design: a phase iii study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma
topic Clinical Trial Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927908/
https://www.ncbi.nlm.nih.gov/pubmed/33533655
http://dx.doi.org/10.2217/fon-2020-0969
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