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
Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Clinical Study Site
RECRUITING
Goodyear
California
Clinical Study Site
RECRUITING
Beverly Hills
Clinical Study Site
RECRUITING
Cerritos
Clinical Study Site
RECRUITING
Corona
Clinical Study Site
RECRUITING
Duarte
Clinical Study Site
RECRUITING
Huntington Beach
Clinical Study Site
RECRUITING
Irvine
Clinical Study Site
RECRUITING
Irvine
Clinical Study Site
RECRUITING
Los Angeles
Clinical Study Site
RECRUITING
Los Angeles
Clinical Study Site
RECRUITING
Murrieta
Clinical Study Site
RECRUITING
Orange
Clinical Study Site
RECRUITING
Pasadena
Clinical Study Site
RECRUITING
Torrance
Clinical Study Site
RECRUITING
Upland
Clinical Study Site
RECRUITING
West Hollywood
Connecticut
Clinical Study Site
RECRUITING
New Haven
Clinical Study Site
RECRUITING
Norwich
Florida
Clinical Study Site
RECRUITING
Hialeah
Clinical Study Site
RECRUITING
Orlando
Clinical Study Site
RECRUITING
Port Saint Lucie
Georgia
Clinical Study Site
RECRUITING
Newnan
Illinois
Clinical Study Site
RECRUITING
Chicago
Clinical Study Site
RECRUITING
Elmhurst
Clinical Study Site
RECRUITING
O'fallon
Indiana
Clinical Study Site
RECRUITING
Fort Wayne
Kentucky
Clinical Study Site
RECRUITING
Edgewood
Minnesota
Clinical Study Site
RECRUITING
Saint Louis Park
Montana
Clinical Study Site
RECRUITING
Billings
Nebraska
Clinical Study Site
RECRUITING
Lincoln
New Jersey
Clinical Study Site
RECRUITING
New Brunswick
New York
Clinical Study Site
RECRUITING
Mineola
Clinical Study Site
RECRUITING
New York
Clinical Study Site
RECRUITING
The Bronx
Ohio
Clinical Study Site
RECRUITING
Cincinnati
Pennsylvania
Clinical Study Site
RECRUITING
Philadelphia
Clinical Study Site
RECRUITING
Philadelphia
Tennessee
Clinical Study Site
RECRUITING
Hermitage
Texas
Clinical Study Site
RECRUITING
Fort Worth
Utah
Clinical Study Site
RECRUITING
Salt Lake City
Virginia
Clinical Study Site
RECRUITING
Charlottesville
Washington
Clinical Study Site
RECRUITING
Spokane
Clinical Study Site
RECRUITING
Tacoma
West Virginia
Clinical Study Site
RECRUITING
Charleston
Other Locations
Canada
Clinical Study Site
RECRUITING
Montreal
Japan
Clinical Study Site
RECRUITING
Aichi
Clinical Study Site
RECRUITING
Chiba
Clinical Study Site
RECRUITING
Fukuoka
Clinical Study Site
RECRUITING
Gifu
Clinical Study Site
RECRUITING
Hokkaido
Clinical Study Site
RECRUITING
Osaka
Clinical Study Site
RECRUITING
Tokyo
Puerto Rico
Clinical Study Site
RECRUITING
Rio Piedras
United Kingdom
Clinical Study Site
RECRUITING
London
Contact Information
Primary
Nindhana Paranthaman, MD
medicalaffairs@summitplc.com
1-833-256-0522
Time Frame
Start Date: 2025-11-18
Estimated Completion Date: 2029-11-30
Participants
Target number of participants: 600
Treatments
Experimental: Arm A: Ivonescimab in combination with mFOLFOX6
Subjects will receive Ivonescimab Plus mFOLFOX6 via intravenous infusion (IV) Q2W, up to 8 cycles. Afterward, Ivonescimab plus Leucovorin and 5-FU will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) up to 2 years.
Active_comparator: Arm B: Bevacizumab in combination with mFOLFOX6
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.
Related Therapeutic Areas
Sponsors
Leads: Summit Therapeutics