A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)
A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)
The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma.
The overall primary efficacy hypotheses are as follows:
Inclusion Criteria:
Exclusion Criteria:
Knoxville, Tennessee 37920, United States
Viedma, Río Negro Province R8500ACE, Argentina
Buenos Aires, C1264AAA, Argentina
Recife, Pernambuco 50070-550, Brazil
Rio de Janeiro, Rio de Janeiro 20231-050, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Santa Maria, Rio Grande do Sul 97015-513, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Concepción, 4070038, Chile
Harbin, Heilongjiang 150081, China
Wuhan, Hubei 430030, China
Hamburg, 20249, Germany
Mönchengladbach, 41063, Germany
Kita-gun, Kagawa-ken 761-0793, Japan
Kitaadachi-gun, Saitama 362-0806, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Comuna Floresti, Cluj 407280, Romania
Port Elizabeth, Eastern Cape 6045, South Africa
Hwasun Gun, Jeollanam-do 58128, South Korea
Oviedo, Principality of Asturias 33011, Spain
Istanbul, 34899, Turkey (Türkiye)