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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...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Future Medicine Ltd
2021
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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) |
format | Online Article Text |
id | pubmed-7927908 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Future Medicine Ltd |
record_format | MEDLINE/PubMed |
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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