drugset / Trial / NCT03382600

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)

NCT03382600 ↗

Phase 2 Completed 100 enrolled Merck Sharp & Dohme LLC
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to estimate objective 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.

Timeline

Start
2018-03-26
Primary completion
2021-05-30
Completion
2021-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 60 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject TS-1 Small molecule 40 mg Oral
Subject TS-1 Small molecule 60 mg Oral

Indications