At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 120 enrolled
Drug / intervention
Pembrolizumab +7 morebiological
Likely dose
Not stated in 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.
A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Placebo, and 6 other interventions for Gastric Cancer and Gastroesophageal Junction Cancer. Completed, enrolled 120 participants across 20 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated Chinese adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. No formal hypothesis testing will be done.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Gastroesophageal Junction Cancer
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartJul 2020
First PostedMay 2021
Primary CompletionFeb 2024
Study CompletionApr 2025
TodayJul 2026
First PostedMay 11, 2021
Enrollment StartJul 29, 2020
Primary CompletionFeb 16, 2024
Study CompletionApr 23, 2025
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 5.1 years ago
Interventions
Pembrolizumabbiological
IV infusion
Placebodrug
IV infusion
Cisplatindrug
IV infusion
Capecitabinedrug
Oral tablets
5-fluorouracildrug
IV infusion
Docetaxeldrug
IV infusion
Oxaliplatindrug
IV infusion
Leucovorindrug
IV infusion