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A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and 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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Trial Profile

A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and 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 II

Latest Information Update: 01 Aug 2024

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At a glance

  • Drugs ONO 4578 (Primary) ; Gimeracil/oteracil/tegafur; Nivolumab; Oxaliplatin
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Therapeutic Use
  • Sponsors Ono Pharmaceutical

Most Recent Events

  • 29 Jul 2024 Planned End Date changed from 31 Dec 2027 to 31 Jul 2027.
  • 29 Jul 2024 Status changed from recruiting to active, no longer recruiting.
  • 16 Feb 2024 New trial record

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