CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Pembrolizumab +3 morebiological
Likely dose
Pembrolizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03382600
NCT03382600Phase 2Completed
CompareCT.gov

A Phase IIb, Clinical Trial to Study the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as a First Line Chemotherapy in Participants With Advanced or Recurrent Gastric Cancer (KEYNOTE-659)

Merck Sharp & Dohme LLC·interventional·Posted Dec 26, 2017·Updated Jun 11, 2024

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab, Oxaliplatin, and 2 other interventions for Gastric Cancer. Completed, enrolled 100 participants across 25 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 26, 2017
Enrollment StartMar 26, 2018
Primary CompletionMay 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8.5 years ago

Interventions

Pembrolizumabbiological

200 mg Q3W on Day 1 by IV infusion

Oxaliplatindrug

130 mg/m\^2 Q3W on Day 1 by IV infusion

TS-1drug

40 to 60 mg orally according to Body Surface Area (BSA) BID Q3W on Days 1-14

Cisplatindrug

60 mg/m\^2 Q3W on Day 1 by IV infusion