Last updated on October 2018

Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as First Line Chemotherapy in Gastric Cancer (MK-3475-659/KEYNOTE-659)


Brief description of study

The purpose of this study is to estimate overall response rates (ORRs) of pembrolizumab + oxaliplatin + TS-1 and pembrolizumab + cisplatin + TS-1, as first-line treatment for gastric cancer in programmed death-ligand 1 (PD-L1) positive, human epidermal growth factor receptor 2 (HER2/neu)-negative participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Detailed Study Description

Approximately 45 participants will be assigned first to pembrolizumab + oxaliplatin + TS-1 combination therapy (Cohort 1), and then 45 participants will be assigned to pembrolizumab + cisplatin + TS-1 combination therapy (Cohort 2).

Clinical Study Identifier: NCT03382600

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Study Coordinator

Gunma Prefectural Cancer Center ( Site 0005)
Ohta, Japan
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Recruitment Status: Open


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