Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer
Summit Therapeutics
600 participants
Nov 18, 2025
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Inclusion Criteria5
- ECOG performance status score of 0 or 1
- Expected life expectancy ≥ 6 months
- Patients with histologically or cytologically confirmed metastatic CRC
- No prior systemic therapy for metastatic CRC
- At least 1 measurable noncerebral lesion
Exclusion Criteria7
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
- Known BRAF V600E mutant status
- Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction
- Ascites requiring paracentesis within last 30 days
- Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer
- Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Resectable disease
Interventions
Subjects will receive Ivonescimab Plus mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) via intravenous infusion (IV) Q2W, up to 8 cycles. Afterward, Ivonescimab plus Leucovorin and 5-Fluorouracil will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) for up to 2 years.
Subjects will receive bevacizumab Plus mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) via intravenous infusion (IV) Q2W, up to 8 cycles in treatment periods per the randomization schedule. Afterward, bevacizumab Plus 5-FU and Leucovorin will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) up to 2 years.
Locations(40)
View Full Details on ClinicalTrials.gov
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NCT07228832