KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer

Future Oncol. 2019 Mar;15(9):943-952. doi: 10.2217/fon-2018-0581. Epub 2019 Feb 19.


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: 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. : NCT03221426.

Keywords: adjuvant therapy; chemotherapy; gastric cancer; gastroesophageal junction cancer; immunotherapy; neoadjuvant therapy; pembrolizumab; surgery.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • 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
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / therapy*
  • Survival Analysis
  • Young Adult


  • Antibodies, Monoclonal, Humanized
  • pembrolizumab

Associated data