Esophageal Neoplasms Clinical Trial
Official title:
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 Chinese extension study is to evaluate efficacy and safety of
pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) chemotherapy versus placebo plus
cisplatin and 5-FU chemotherapy as first-line treatment in a Chinese cohort of participants
with locally advanced or metastatic esophageal carcinoma.
The primary efficacy hypotheses are that both progression-free survival (PFS), according to
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and determined by blinded
independent central review, and overall survival (OS) are superior with pembrolizumab plus
chemotherapy compared with placebo plus chemotherapy in all Chinese participants as well as
Chinese participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive.
The Chinese extension to MK-3475-590 (NCT03189719) will enroll a total of approximately 90 participants. ;
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