NCT04882241

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Extension

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The China extension study will include participants previously enrolled in China in the global study for MK-3475-585 (NCT03221426) plus those enrolled during the China extension enrollment period. A total of approximately 120 Chinese participants will be enrolled.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV infusion
DRUG	Placebo	IV infusion
DRUG	Cisplatin	IV infusion
DRUG	Capecitabine	Oral tablets
DRUG	5-fluorouracil	IV infusion
DRUG	Docetaxel	IV infusion
DRUG	Oxaliplatin	IV infusion
DRUG	Leucovorin	IV infusion

Timeline

• Start date: 2020-07-29
• Primary completion: 2024-02-16
• Completion: 2025-04-23
• First posted: 2021-05-11
• Last updated: 2026-03-06
• Results posted: 2025-02-20

Locations

20 sites across 1 country: China

Regulatory

• FDA-regulated drug study