Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)

Official Title

A Phase III Open-label, Multicentre Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction


The purpose of this study is to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.

Trial Description

Primary Outcome:

  • Overall Survival (OS) Time
  • Progression-Free Survival (PFS) Time
Secondary Outcome:
  • Best Overall Response (BOR)
  • Change From Baseline in European Quality Of Life 5-dimensions-5 Levels (EQ-5D-5L) Health Outcome Questionnaire
  • Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)
  • Change From Baseline in European Organization for Research and Treatment of Cancer Gastric Cancer Module QLQ-STO22
  • Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society