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A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of May 2026 to Oct 20, 2025 Secondary endpoints: details revised at 9 of 9 entriesv13 Show 1 more changeShow less
    • Secondary endpoints: details revised at 9 of 9 entries
  2. Primary completion date: Dec 2024 to May 2026v12
  3. Primary completion date: Feb 2027 to Dec 2024v11
  4. 2 versions Re-verified since Mar 14, 2024, no change to tracked fieldsv9-v10
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 600 to confirmed 626 · Site details revised at 57 of 57 sitesv8 Show 2 more changesShow less
    • Enrollment target: estimated 600 to confirmed 626
    • Site details revised at 57 of 57 sites
Show 6 earlier versionsHide 6 earlier versions
  1. Re-verified, no change to tracked fieldsv7
  2. Site details revised at 11 of 57 sitesv6
  3. Site details revised at 3 of 57 sitesv5
  4. Study sites: 54 to 57v4
  5. Site details revised at 9 of 54 sitesv3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 7 to 54 · Start date changed from estimate of Dec 2021 to Nov 5, 2021v2 Show 2 more changesShow less
    • Study sites: 7 to 54
    • Start date changed from estimate of Dec 2021 to Nov 5, 2021
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
Trial Details
NCT Number NCT05144854
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Gastric Cancer
Enrollment 626 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov