Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

Official Title

A Randomized, Multicentre, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Summary:

The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

Trial Description

Primary Outcome:

  • Overall survival (OS) of nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in programmed cell death ligand 1 (PD-L1) positive participants
  • Progression-free survival (PFS), as assessed by Blinded Independent Central Review (BICR), of nivolumab in combination with oxaliplatin plus fluoropyrimidine versus oxaliplatin plus fluoropyrimidine in PD-L1 positive participants
Secondary Outcome:
  • OS in all randomized participants
  • PFS, as assessed by BICR, in all randomized participants
  • Objective Response Rate (ORR), as assessed by BICR, in all randomized participants
  • Time to symptom deterioration (TTSD) of nivolumab + ipilimumab vs oxaliplatin + fluoropyrimidine in all randomized participants

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