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

Autor: Bang, Yung-Jue, Van Cutsem, E., Fuchs, C.S., Ohtsu, A., Tabernero, Josep, Ilson, D.H., Hyung, W.J., Strong, V.E., Goetze, T.O., Yoshikawa, T., Tang, L.H., Hwang, P.M.T., Webb, N., Adelberg, D., Shitara, K., Universitat Autònoma de Barcelona
Rok vydání: 2019
Předmět:
Zdroj: Dipòsit Digital de Documents de la UAB
Universitat Autònoma de Barcelona
Popis: Medical writing and/or editorial assistance was provided by M Sweetlove, and SS Shaevitz, of the ApotheCom pembrolizumab team (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. 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: NCT0322142.
Databáze: OpenAIRE