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A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Changed Sponsor changed: Ono Pharmaceutical Co. Ltd to Ono Pharmaceutical Co., Ltd.
  2. Enrollment target: estimated 210 to confirmed 226v5
  3. Start date: Dec 6, 2023 to Jan 10, 2024 Primary completion date changed from estimate of Nov 30, 2025 to Oct 9, 2025 · Site details revised at 1 of 63 sitesv4 Show 2 more changesShow less
    • Primary completion date changed from estimate of Nov 30, 2025 to Oct 9, 2025
    • Site details revised at 1 of 63 sites
  4. Trial status: Recruiting to Active, Not Recruiting Completion date: Dec 31, 2027 to Jul 31, 2027 · Site details revised at 63 of 63 sitesv3 Show 2 more changesShow less
    • Completion date: Dec 31, 2027 to Jul 31, 2027
    • Site details revised at 63 of 63 sites
  5. Study sites: 3 to 63v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
Trial Details
NCT Number NCT06256328
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Gastric Cancer
Enrollment 226 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov