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

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.

Timeline

Start

2020-07-29

Primary completion

2024-02-16

Completion

2025-04-23

Outcome

Missed primary endpoint

registry p = 0.39528; Hazard Ratio (HR) 0.92 (95% CI 0.50 to 1.70) NCT04882241 ↗

registry p = 0.33244; Difference in Percentage 1.9 (95% CI -7.7 to 12.0) NCT04882241 ↗

registry p = 0.52903; Hazard Ratio (HR) 1.03 (95% CI 0.48 to 2.22) NCT04882241 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Background	Capecitabine	Small molecule	1000 mg/m2	Oral
Background	Cisplatin	Other / unclassified	80 mg/m2	Intravenous
Background	Docetaxel	Small molecule	50 mg/m2	Intravenous
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2600 mg/m2	Intravenous

Indications