Summary
The main goal of this study is to test the safety and benefits of the study drug Ivonescimab when it is given with drug called FOLFOX, a mix a platinum-based chemo drug used to treat certain cancers, most notably colorectal cancer. This treatment will be compared to another drug, Avastin, which is also given with FOLFOX, for people receiving their first treatment for cancer. This drug AK-112 is a new drug and has not been approved for use or sale by the U.S. Food and Drug Administration or local health authorities. Avastin is an approved drug.
Description
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.
Principal Investigator
Study Coordinator
Faculty Contact
Lisa Luikart - lisa.luikart@vandaliahealth.org