First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811.
Adenocarcinoma
/ diagnosis
Adult
Aged
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Clinical Trials, Phase III as Topic
Double-Blind Method
Drug Administration Schedule
Esophagogastric Junction
/ pathology
Female
Humans
Male
Middle Aged
Neoplasm Staging
Placebos
/ administration & dosage
Progression-Free Survival
Randomized Controlled Trials as Topic
Receptor, ErbB-2
/ analysis
Stomach Neoplasms
/ diagnosis
Trastuzumab
/ administration & dosage
chemotherapy
first-line therapy
gastric cancer
gastroesophageal junction cancer
human epidermal growth factor receptor 2
pembrolizumab
trastuzumab
Journal
Future oncology (London, England)
ISSN: 1744-8301
Titre abrégé: Future Oncol
Pays: England
ID NLM: 101256629
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
pubmed:
11
11
2020
medline:
28
9
2021
entrez:
10
11
2020
Statut:
ppublish
Résumé
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).
Identifiants
pubmed: 33167735
doi: 10.2217/fon-2020-0737
pmc: PMC8411394
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Placebos
0
pembrolizumab
DPT0O3T46P
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
Trastuzumab
P188ANX8CK
Banques de données
ClinicalTrials.gov
['NCT03615326']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
491-501Subventions
Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Organisme : Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., NJ, USA
Organisme : Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
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