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)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07228832.
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.
Lead OrganizationSummit Therapeutics
