Avelumab in First-Line 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

Summary:

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)
  • Progression free survival (PFS)
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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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society