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 + ipilimumab versus oxaliplatin + fluoropyrimidine in patients with programmed cell death ligand 1 (PD-L1) expressing tumours
  • OS of nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in patients with PD-L1 expressing tumours
Secondary Outcome:
  • OS of nivolumab + ipilimumab or nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in all randomized patients
  • Progression-free Survival (PFS) of nivolumab + ipilimumab or nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in patients with PD-L1 expressing tumours and all randomized patients
  • Time to Symptom Deterioration of nivolumab + ipilimumab or nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in patients with PD-L1 expressing tumours and all randomized patients

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