Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

Study acronym: HARMONi-GI3
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 213 → 236 locations
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Trial sites expanded: 185 → 213 locationsv12
  3. Trial sites expanded: 166 → 185 locationsv11
  4. Trial sites expanded: 140 → 166 locationsv10
  5. Trial sites expanded: 130 → 140 locationsv9
  6. Trial sites expanded: 91 → 130 locations
    • Trial sites expanded: 76 → 91 locations
    v8
  7. Study sites: 76 to 91v7
  8. Re-verified, no change to tracked fieldsv6
  9. Trial sites expanded: 54 → 76 locationsv5
  10. Trial sites expanded: 40 → 54 locationsv4
  11. Study sites: 9 to 40v3
  12. Study sites: 4 to 9
    • Start date changed from estimate of Nov 15, 2025 to Nov 18, 2025
    v2
  13. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)
Trial Details
NCT Number NCT07228832
Lead Sponsor Summit Therapeutics
Conditions
(from sponsor)		 Metastatic Colorectal Cancer (CRC)
Related terms Colorectal Neoplasms
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov