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 (209) 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
Alabama
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Mobile
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Tuscaloosa
Arizona
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Goodyear
California
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Beverly Hills
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Beverly Hills
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Cerritos
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Corona
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Duarte
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Fountain Valley
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Huntington Beach
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Irvine
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Irvine
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Los Angeles
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Los Angeles
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Los Angeles
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Murrieta
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Oakland
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Orange
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Pasadena
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Roseville
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San Francisco
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Santa Clara
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Stanford
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Torrance
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Upland
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Vallejo
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West Hollywood
Connecticut
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Hartford
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New Haven
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Norwich
Delaware
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Newark
Florida
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Hialeah
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Miami
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Miami Beach
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Ocala
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Orlando
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Orlando
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Plantation
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Port Saint Lucie
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St. Petersburg
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Tamarac
Georgia
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Atlanta
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Atlanta
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Newnan
Illinois
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Chicago
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Elmhurst
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O'fallon
Indiana
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Fort Wayne
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Indianapolis
Kansas
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Westwood
Kentucky
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Edgewood
Louisiana
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New Orleans
Maryland
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Baltimore
Michigan
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Detroit
Minnesota
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Saint Louis Park
Missouri
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Springfield
Montana
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Billings
North Carolina
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Pinehurst
Nebraska
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Lincoln
New Hampshire
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Lebanon
New Jersey
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New Brunswick
New York
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Mineola
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New York
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Rochester
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Syracuse
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The Bronx
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White Plains
Ohio
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Akron
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Canton
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Cincinnati
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Cincinnati
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Cleveland
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Cleveland
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Mayfield Heights
Oklahoma
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Oklahoma City
Pennsylvania
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Lebanon
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Philadelphia
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Philadelphia
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Philadelphia
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Pittsburgh
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Pittsburgh
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Sellersville
Rhode Island
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Providence
South Carolina
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Greenville
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Spartanburg
Tennessee
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Germantown
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Hermitage
Texas
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Dallas
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Dallas
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Fort Worth
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Houston
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Houston
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Tyler
Utah
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Salt Lake City
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Salt Lake City
Virginia
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Charlottesville
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Fairfax
Vermont
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Burlington
Washington
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Spokane
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Tacoma
Wisconsin
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Madison
West Virginia
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Charleston
Other Locations
Belgium
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Brussels
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Ghent
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Haine-saint-paul
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Kortrijk
Canada
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Montreal
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Regina
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Toronto
China
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Beijing
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Ch’ang-ch’un
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Changsha
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Chengdu
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Chifeng
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Foshan
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Fuzhou
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Fuzhou
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Guangzhou
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Guangzhou
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Haikou
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Hangzhou
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Hangzhou
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Harbin
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Jinan
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Kunming
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Luzhou
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Nanchang
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Nanjing
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Ningbo
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Shanghai
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Shenyang
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Shenzhen
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Shijiazhuang
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Wenzhou
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Wuhan
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Yueyang
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Zhengzhou
France
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Bordeaux
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Lille
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Lyon
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Montpellier
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Nantes
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Nice
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Paris
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Paris
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Pierre-bénite
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Poitiers
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Strasbourg
Germany
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Berlin
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Bonn
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Hamburg
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Hamburg
Hungary
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Budapest
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Debrecen
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Kecskemét
Italy
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Brescia
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Florence
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Genova
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Meldola
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Pisa
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Verona
Japan
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Aichi
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Chiba
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Ehime
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Fukuoka
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Gifu
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Hiroshima
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Hokkaido
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Kawasaki
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Osaka
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Osaka
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Saitama
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Sendai
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Shizuoka
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Tokyo
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Tokyo
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Tokyo
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Toyama
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Yokohama
Poland
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Gdansk
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Olsztyn
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Otwock
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Rzeszów
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Warsaw
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Warsaw
Puerto Rico
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Rio Piedras
Spain
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A Coruña
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Barcelona
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Barcelona
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Barcelona
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Barcelona
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Granada
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Madrid
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Madrid
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Madrid
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Madrid
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Málaga
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Palma De Mallorca
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Santander
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Seville
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Valencia
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Valencia
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Valencia
United Kingdom
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Aberdeen
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Canterbury
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Edinburgh
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Liverpool
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London
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Manchester
Contact Information
Primary
Ning Chang, 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