KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer.
Adult
Antibodies, Monoclonal, Humanized
/ therapeutic use
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Chemotherapy, Adjuvant
/ methods
Clinical Trials, Phase III as Topic
Disease-Free Survival
Double-Blind Method
Female
Gastrectomy
Humans
Male
Multicenter Studies as Topic
Neoadjuvant Therapy
/ methods
Perioperative Care
/ methods
Randomized Controlled Trials as Topic
Stomach Neoplasms
/ mortality
Survival Analysis
Young Adult
adjuvant therapy
chemotherapy
gastric cancer
gastroesophageal junction cancer
immunotherapy
neoadjuvant therapy
pembrolizumab
surgery
Journal
Future oncology (London, England)
ISSN: 1744-8301
Titre abrégé: Future Oncol
Pays: England
ID NLM: 101256629
Informations de publication
Date de publication:
Mar 2019
Mar 2019
Historique:
pubmed:
20
2
2019
medline:
2
7
2019
entrez:
20
2
2019
Statut:
ppublish
Résumé
Surgical resection is the only curative treatment option for gastric cancer. Despite widespread adoption of multimodality perioperative treatment strategies, 5-year overall survival rates remain low. In patients with advanced gastric or gastroesophageal junction adenocarcinoma, pembrolizumab has demonstrated promising efficacy and manageable safety as monotherapy in previously treated patients and as first-line therapy in combination with cisplatin and 5-fluorouracil. Combining chemotherapy with pembrolizumab in the neoadjuvant/adjuvant setting may benefit patients with locally advanced, resectable disease. To describe the design and rationale for the global, multicenter, randomized, double-blind, Phase III KEYNOTE-585 study to evaluate the efficacy and safety of pembrolizumab plus chemotherapy compared with placebo plus chemotherapy as neoadjuvant/adjuvant treatment for localized gastric or gastroesophageal junction adenocarcinoma. ClinicalTrials.gov : NCT03221426.
Sections du résumé
BACKGROUND
BACKGROUND
Surgical resection is the only curative treatment option for gastric cancer. Despite widespread adoption of multimodality perioperative treatment strategies, 5-year overall survival rates remain low. In patients with advanced gastric or gastroesophageal junction adenocarcinoma, pembrolizumab has demonstrated promising efficacy and manageable safety as monotherapy in previously treated patients and as first-line therapy in combination with cisplatin and 5-fluorouracil. Combining chemotherapy with pembrolizumab in the neoadjuvant/adjuvant setting may benefit patients with locally advanced, resectable disease.
AIM
OBJECTIVE
To describe the design and rationale for the global, multicenter, randomized, double-blind, Phase III KEYNOTE-585 study to evaluate the efficacy and safety of pembrolizumab plus chemotherapy compared with placebo plus chemotherapy as neoadjuvant/adjuvant treatment for localized gastric or gastroesophageal junction adenocarcinoma. ClinicalTrials.gov : NCT03221426.
Identifiants
pubmed: 30777447
doi: 10.2217/fon-2018-0581
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
pembrolizumab
DPT0O3T46P
Banques de données
ClinicalTrials.gov
['NCT03221426']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM