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A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

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A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Sep 2024

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At a glance

  • Drugs Capecitabine (Primary) ; Gimeracil/oteracil/tegafur (Primary) ; Ipilimumab (Primary) ; Nivolumab (Primary) ; Oxaliplatin (Primary)
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Ono Pharmaceutical

    • Most Recent Events

    • 05 Sep 2024 Planned primary completion date changed from 1 Dec 2024 to 1 May 2026.
    • 31 Jul 2024 Planned primary completion date changed from 1 Feb 2027 to 1 Dec 2024.
    • 01 Sep 2023 Status changed from not yet recruiting to active, no longer recruiting.

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