KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer
Yung-Jue Bang, Eric Van Cutsem, Charles S Fuchs, Atsushi Ohtsu, Josep Tabernero, David H Ilson, Woo Jin Hyung, Vivian E Strong, Thorsten Oliver Goetze, Takaki Yoshikawa, Laura H Tang, Peggy May Tan Hwang, Nancy Webb, David Adelberg, Kohei Shitara, Yung-Jue Bang, Eric Van Cutsem, Charles S Fuchs, Atsushi Ohtsu, Josep Tabernero, David H Ilson, Woo Jin Hyung, Vivian E Strong, Thorsten Oliver Goetze, Takaki Yoshikawa, Laura H Tang, Peggy May Tan Hwang, Nancy Webb, David Adelberg, Kohei Shitara
Abstract
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. ClinicalTrials.gov : NCT03221426.
Keywords: adjuvant therapy; chemotherapy; gastric cancer; gastroesophageal junction cancer; immunotherapy; neoadjuvant therapy; pembrolizumab; surgery.
Source: PubMed