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 mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)
Inclusion Criteria
- 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 Criteria
- 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07228832.
Locations matching your search criteria
United States
California
Arcadia
Corona
Duarte
Huntington Beach
Irvine
Los Angeles
Torrance
Upland
Connecticut
Derby
New Haven
North Haven
Torrington
Trumbull
Waterbury
Waterford
Georgia
Atlanta
Michigan
Detroit
New Jersey
New Brunswick
New York
New York
Pennsylvania
Philadelphia
Texas
Houston
Virginia
Charlottesville
Wisconsin
Madison
This trial will be performed as a phase 3, randomized, active-controlled, double-blind,
multiregional study comparing Ivonescimab in combination with mFOLFOX6 (Oxaliplatin,
Leucovorin and 5-Fluorouracil) versus Bevacizumab in combination with mFOLFOX6 in
patients with metastatic colorectal cancer who have not previously received systemic
therapy for metastatic disease. Approximately 600 patients will be randomly assigned to
the 2 treatment groups in a 1:1 ratio. Each enrolled subject will receive an intravenous
infusion of the Ivonescimab/Bevacizumab Plus mFOLFOX6 (Q2W, up to 8 cycles) in treatment
periods per the randomization schedule. Afterward, Ivonescimab/ Bevacizumab Plus
5-Fluorouracil and Leucovorin will be used for maintenance treatment (administered on Day
1 of each cycle, Q2W) for up to 2 years.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationSummit Therapeutics
- Primary IDSMT112-3005
- Secondary IDsNCI-2025-09154
- ClinicalTrials.gov IDNCT07228832