Open AccessKEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma
Author(s) -
Manish A. Shah,
Jaafar Bennouna,
Toshihiko Doi,
Lin Shen,
Ken Kato,
Antoine Adenis,
Harvey J. Mamon,
Markus Moehler,
Xiao–Long Fu,
Byoung Chul Cho,
Sonal Bordia,
Pooja Bhagia,
Chie Schin Shih,
Anjali Desai,
Peter C. Enzinger
Publication year - 2021
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2020-0969
Subject(s) - medicine , pembrolizumab , chemoradiotherapy , esophageal cancer , oncology , placebo , phases of clinical research , clinical trial , cancer , surgery , immunotherapy , pathology , alternative medicine
Despite curative-intent treatment, most patients with locally advanced esophageal cancer will experience disease recurrence or locoregional progression, highlighting the need for new therapies. Current guidelines recommend definitive chemoradiotherapy in patients ineligible for surgical resection, but survival outcomes are poor. Pembrolizumab is well tolerated and provides promising antitumor activity in patients with previously treated, advanced, unresectable esophageal/esophagogastric junction cancer. Combining pembrolizumab with chemoradiotherapy may further improve outcomes in the first-line setting. Here, we describe the design and rationale for the double-blind, Phase III, placebo-controlled, randomized KEYNOTE-975 trial investigating pembrolizumab in combination with definitive chemoradiotherapy as first-line treatment in patients with locally advanced, unresectable esophageal/gastroesophageal junction cancer. Overall survival and event-free survival are the dual primary end points. Clinical trial registration: NCT04210115 (ClinicalTrials.gov)