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Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
Sponsor: Summit Therapeutics
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)
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-11-18
Completion Date
2029-11-30
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
Drug: Ivonescimab Injection
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.
Drug: Bevacizumab Injection
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 (236)
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Mobile, Alabama, United States
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Tuscaloosa, Alabama, United States
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Goodyear, Arizona, United States
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Beverly Hills, California, United States
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Beverly Hills, California, United States
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Cerritos, California, United States
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Corona, California, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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Huntington Beach, California, United States
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Irvine, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Murrieta, California, United States
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Oakland, California, United States
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Orange, California, United States
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Pasadena, California, United States
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Roseville, California, United States
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San Francisco, California, United States
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Santa Clara, California, United States
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Stanford, California, United States
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Torrance, California, United States
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Upland, California, United States
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Vallejo, California, United States
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West Hollywood, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Highlands Ranch, Colorado, United States
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Lone Tree, Colorado, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Norwich, Connecticut, United States
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Newark, Delaware, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Port Saint Lucie, Florida, United States
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St. Petersburg, Florida, United States
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Tamarac, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Newnan, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Elmhurst, Illinois, United States
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O'Fallon, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Westwood, Kansas, United States
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Edgewood, Kentucky, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Danvers, Massachusetts, United States
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Newton, Massachusetts, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Springfield, Missouri, United States
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Billings, Montana, United States
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Lincoln, Nebraska, United States
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Lebanon, New Hampshire, United States
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Camden, New Jersey, United States
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New Brunswick, New Jersey, United States
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Mineola, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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White Plains, New York, United States
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Pinehurst, North Carolina, United States
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Akron, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Mayfield Heights, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Lebanon, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Providence, Rhode Island, United States
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Greenville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Germantown, Tennessee, United States
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Hermitage, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States