First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811

Treatment options for patients with HER2-positive advanced gastric cancer are limited, and the prognosis for these patients is poor. Pembrolizumab has demonstrated promising antitumor activity in patients with advanced gastric or gastroesophageal junction adenocarcinoma as monotherapy, in combinatio...

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Autores principales: Chung, Hyun Cheol, Bang, Yung-Jue, S Fuchs, Charles, Qin, Shu-Kui, Satoh, Taroh, Shitara, Kohei, Tabernero, Josep, van Cutsem, Eric, Alsina, Maria, Cao, Zhu Alexander, Lu, Jia, Bhagia, Pooja, Shih, Chie-Schin, Janjigian, Yelena Y
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Future Medicine Ltd 2020
Materias:
Clinical Trial Protocol
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411394/
https://www.ncbi.nlm.nih.gov/pubmed/33167735
http://dx.doi.org/10.2217/fon-2020-0737
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author Chung, Hyun Cheol
Bang, Yung-Jue
S Fuchs, Charles
Qin, Shu-Kui
Satoh, Taroh
Shitara, Kohei
Tabernero, Josep
van Cutsem, Eric
Alsina, Maria
Cao, Zhu Alexander
Lu, Jia
Bhagia, Pooja
Shih, Chie-Schin
Janjigian, Yelena Y
author_facet Chung, Hyun Cheol
Bang, Yung-Jue
S Fuchs, Charles
Qin, Shu-Kui
Satoh, Taroh
Shitara, Kohei
Tabernero, Josep
van Cutsem, Eric
Alsina, Maria
Cao, Zhu Alexander
Lu, Jia
Bhagia, Pooja
Shih, Chie-Schin
Janjigian, Yelena Y
author_sort Chung, Hyun Cheol
collection PubMed
description Treatment options for patients with HER2-positive advanced gastric cancer are limited, and the prognosis for these patients is poor. Pembrolizumab has demonstrated promising antitumor activity in patients with advanced gastric or gastroesophageal junction adenocarcinoma as monotherapy, in combination with chemotherapy and in combination with trastuzumab. Combining pembrolizumab with trastuzumab and chemotherapy may therefore provide a benefit for patients with advanced HER2-positive gastric cancer. Here we aimed to describe the design of and rationale for the randomized, double-blind, placebo-controlled Phase III KEYNOTE-811 study, which will evaluate the efficacy and safety of pembrolizumab or placebo in combination with trastuzumab and chemotherapy as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. Clinical trial registration: NCT03615326 (ClinicalTrials.gov)
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spelling pubmed-84113942021-09-03 First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811 Chung, Hyun Cheol Bang, Yung-Jue S Fuchs, Charles Qin, Shu-Kui Satoh, Taroh Shitara, Kohei Tabernero, Josep van Cutsem, Eric Alsina, Maria Cao, Zhu Alexander Lu, Jia Bhagia, Pooja Shih, Chie-Schin Janjigian, Yelena Y Future Oncol Clinical Trial Protocol Treatment options for patients with HER2-positive advanced gastric cancer are limited, and the prognosis for these patients is poor. Pembrolizumab has demonstrated promising antitumor activity in patients with advanced gastric or gastroesophageal junction adenocarcinoma as monotherapy, in combination with chemotherapy and in combination with trastuzumab. Combining pembrolizumab with trastuzumab and chemotherapy may therefore provide a benefit for patients with advanced HER2-positive gastric cancer. Here we aimed to describe the design of and rationale for the randomized, double-blind, placebo-controlled Phase III KEYNOTE-811 study, which will evaluate the efficacy and safety of pembrolizumab or placebo in combination with trastuzumab and chemotherapy as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma. Clinical trial registration: NCT03615326 (ClinicalTrials.gov) Future Medicine Ltd 2020-11-10 2021-02 /pmc/articles/PMC8411394/ /pubmed/33167735 http://dx.doi.org/10.2217/fon-2020-0737 Text en © 2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., https://creativecommons.org/licenses/by-nc-nd/4.0/This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License (https://creativecommons.org/licenses/by-nc-nd/4.0/)
spellingShingle Clinical Trial Protocol
Chung, Hyun Cheol
Bang, Yung-Jue
S Fuchs, Charles
Qin, Shu-Kui
Satoh, Taroh
Shitara, Kohei
Tabernero, Josep
van Cutsem, Eric
Alsina, Maria
Cao, Zhu Alexander
Lu, Jia
Bhagia, Pooja
Shih, Chie-Schin
Janjigian, Yelena Y
First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811
title First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811
title_full First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811
title_fullStr First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811
title_full_unstemmed First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811
title_short First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811
title_sort first-line pembrolizumab/placebo plus trastuzumab and chemotherapy in her2-positive advanced gastric cancer: keynote-811
topic Clinical Trial Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411394/
https://www.ncbi.nlm.nih.gov/pubmed/33167735
http://dx.doi.org/10.2217/fon-2020-0737
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