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A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 35 → 39 locationsv7
  2. Study sites: 33 to 35v6
  3. Trial sites expanded: 28 → 33 locationsv5
  4. Sponsor changed: Ono Pharmaceutical Co. Ltd to Ono Pharmaceutical Co., Ltd. Study sites: 17 to 28v4 Show 1 more changeShow less
    • Study sites: 17 to 28

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 12 to 17v3
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 31, 2025 to Nov 18, 2025 · Study sites: 0 to 12v2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 31, 2025 to Nov 18, 2025
    • Study sites: 0 to 12
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.
Trial Details
NCT Number NCT06948448
Lead Sponsor Ono Pharmaceutical Co., Ltd.
Conditions Colorectal Cancer
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov