Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer (HARMONi-GI3)
September 4, 2026 updated by: Summit Therapeutics
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
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
600
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ning Chang, MD
- Phone Number: 1-833-256-0522
- Email: medicalaffairs@summitplc.com
Study Locations
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Brussels, Belgium, 1000
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Ghent, Belgium, 9000
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Haine-Saint-Paul, Belgium, 7100
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Kortrijk, Belgium, 8500
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T7T1
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100020
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Fujian
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Fuzhou, Fujian, China, 350014
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Guangzhou, Fujian, China, 350004
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Guangdong
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Foshan, Guangdong, China, 528000
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Guangzhou, Guangdong, China, 510630
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Shenzhen, Guangdong, China, 518101
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Hainan
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Haikou, Hainan, China, 570145
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Hebei
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Shijiazhuang, Hebei, China, 50011
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Heilongjiang
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Harbin, Heilongjiang, China, 150081
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Henan
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Fuzhou, Henan, China, 455000
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Zhengzhou, Henan, China, 450052
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Hubei
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Wuhan, Hubei, China, 430022
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Hunan
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Changsha, Hunan, China, 410013
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Yueyang, Hunan, China, 414020
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Inner Mongolia
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Chifeng, Inner Mongolia, China, 24000
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Jiangsu
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Nanjing, Jiangsu, China, 210009
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Jiangxi
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Nanchang, Jiangxi, China, 330006
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Jilin
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Ch’ang-ch’un, Jilin, China, 130012
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Liaoning
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Shenyang, Liaoning, China, 110001
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Shandong
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Jinan, Shandong, China, 250021
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
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Sichuan
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Chengdu, Sichuan, China, 610041
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Luzhou, Sichuan, China, 646000
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Yunnan
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Kunming, Yunnan, China, 650118
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
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Hangzhou, Zhejiang, China, 310022
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Ningbo, Zhejiang, China, 315040
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Wenzhou, Zhejiang, China, 325000
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Hradec Králové, Czechia, 50005
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Olomouc, Czechia, 779 00
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Prague, Czechia, 14059
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Prague, Czechia, 128 00
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Bordeaux, France, 33076
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Lille, France, 59000
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Lyon, France, 69374
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Montpellier, France, 34298
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Nantes, France, 44000
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Nice, France, 06189
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Paris, France, 75020
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Paris, France, 75015
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Pierre-Bénite, France, 69495
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Poitiers, France, 86000
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Strasbourg, France, 67033
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Berlin, Germany, 13353
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Bonn, Germany, 53113
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Hamburg, Germany, 22763
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Hamburg, Germany, 20249
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Budapest, Hungary, 1122
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Debrecen, Hungary, 4032
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Kecskemét, Hungary, H-6000
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Brescia, Italy, 25124
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Florence, Italy, 50134
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Genova, Italy, 16132
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Meldola, Italy, 47014
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Pisa, Italy, 56126
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Verona, Italy, 37134
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Aichi, Japan, 464-8681
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Chiba, Japan, 260-8717
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Ehime, Japan, 791-0280
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Fukuoka, Japan, 812-8582
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Gifu, Japan, 501-1194
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Hiroshima, Japan, 734-8551
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Hokkaido, Japan, 060-8648
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Kawasaki, Japan, 216-8511
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Osaka, Japan, 541-8567
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Saitama, Japan, 362-0806
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Sendai, Japan, 980-0872
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Shizuoka, Japan, 411-8777
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Tokyo, Japan, 104-0045
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Tokyo, Japan, 135-8550
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Tokyo, Japan, 113-8677
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Toyama, Japan, 930-0194
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Yokohama, Japan, 241-8515
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Ontario
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Osaka, Ontario, Japan, 565-0871
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Gdansk, Poland, 80-219
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Olsztyn, Poland, 10-228
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Otwock, Poland, 05-400
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Warsaw, Poland, 04-141
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Warsaw, Poland, 02-781
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, Poland, 35-021
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Rio Piedras, Puerto Rico, 00935
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A Coruña, Spain, 15006
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Barcelona, Spain, 08035
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Barcelona, Spain, 08916
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Barcelona, Spain, 08908
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Barcelona, Spain, 08036
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Granada, Spain, 18014
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Madrid, Spain, 28222
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Madrid, Spain, 28046
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Madrid, Spain, 28009
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Madrid, Spain, 28050
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Málaga, Spain, 29010
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Palma de Mallorca, Spain, 07198
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Santander, Spain, 39008
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Seville, Spain, 41013
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Valencia, Spain, 46014
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Valencia, Spain, 46026
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Valencia, Spain, 46010
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Edinburgh, United Kingdom, EH4 2XU
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Liverpool, United Kingdom, L7 8YA
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Manchester, United Kingdom, M20 4BX
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England
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Canterbury, England, United Kingdom, CT13NS
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London, England, United Kingdom, EC1M 6BQ
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Scotland
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Aberdeen, Scotland, United Kingdom, AB25 2ZN
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Alabama
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Mobile, Alabama, United States, 36604
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Tuscaloosa, Alabama, United States, 35487
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Arizona
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Goodyear, Arizona, United States, 85338
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California
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Beverly Hills, California, United States, 90211
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Beverly Hills, California, United States, 90212
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Cerritos, California, United States, 90703
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Corona, California, United States, 92882
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Duarte, California, United States, 91010
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Fountain Valley, California, United States, 92708
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Huntington Beach, California, United States, 92648
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Irvine, California, United States, 92612
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Irvine, California, United States, 92618
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- Clinical Study Site
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Los Angeles, California, United States, 90027
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Los Angeles, California, United States, 90067
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Los Angeles, California, United States, 90404
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Murrieta, California, United States, 92562
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Oakland, California, United States, 94611
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Orange, California, United States, 92868
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Pasadena, California, United States, 91030
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Roseville, California, United States, 95661
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San Francisco, California, United States, 94115
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Santa Clara, California, United States, 94115
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Stanford, California, United States, 94305
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Torrance, California, United States, 90503
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Upland, California, United States, 91786
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Vallejo, California, United States, 94589
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West Hollywood, California, United States, 90048
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Connecticut
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Hartford, Connecticut, United States, 06106
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New Haven, Connecticut, United States, 06520-8028
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Norwich, Connecticut, United States, 06360
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Delaware
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Newark, Delaware, United States, 19713
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Florida
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Hialeah, Florida, United States, 33013
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- Clinical Study Site
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Miami, Florida, United States, 33176
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Miami Beach, Florida, United States, 33140
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Ocala, Florida, United States, 34474
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- Clinical Study Site
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Orlando, Florida, United States, 32806
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Orlando, Florida, United States, 32804
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Plantation, Florida, United States, 33322
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Port Saint Lucie, Florida, United States, 34952
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- Clinical Study Site
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St. Petersburg, Florida, United States, 33705
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Tamarac, Florida, United States, 33321
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Georgia
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Atlanta, Georgia, United States, 30322
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Atlanta, Georgia, United States, 30303
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Newnan, Georgia, United States, 30265
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Illinois
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Chicago, Illinois, United States, 60611
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- Clinical Study Site
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Elmhurst, Illinois, United States, 60540
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O'Fallon, Illinois, United States, 62269
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Indiana
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Fort Wayne, Indiana, United States, 46804
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- Clinical Study Site
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Indianapolis, Indiana, United States, 46202
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Kansas
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Westwood, Kansas, United States, 66205
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- Clinical Study Site
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Kentucky
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Edgewood, Kentucky, United States, 41017
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- Clinical Study Site
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Louisiana
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New Orleans, Louisiana, United States, 70121
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- Clinical Study Site
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Maryland
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Baltimore, Maryland, United States, 21201
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Michigan
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Detroit, Michigan, United States, 48201
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Minnesota
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Saint Louis Park, Minnesota, United States, 55426
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- Clinical Study Site
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Missouri
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Springfield, Missouri, United States, 65804
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Montana
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Billings, Montana, United States, 59102
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- Clinical Study Site
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Nebraska
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Lincoln, Nebraska, United States, 68506
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- Clinical Study Site
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
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New Jersey
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New Brunswick, New Jersey, United States, 08901
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New York
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Mineola, New York, United States, 11501
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- Clinical Study Site
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New York, New York, United States, 10016
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- Clinical Study Site
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Rochester, New York, United States, 14642
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- Clinical Study Site
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Syracuse, New York, United States, 13210
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- Clinical Study Site
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The Bronx, New York, United States, 10461
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- Clinical Study Site
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White Plains, New York, United States, 10601-5000
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North Carolina
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Pinehurst, North Carolina, United States, 28374
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- Clinical Study Site
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Ohio
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Akron, Ohio, United States, 44032
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- Clinical Study Site
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Canton, Ohio, United States, 44703
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- Clinical Study Site
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Cincinnati, Ohio, United States, 45219
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- Clinical Study Site
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Cincinnati, Ohio, United States, 45220
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- Clinical Study Site
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Cleveland, Ohio, United States, 44195
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- Clinical Study Site
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Cleveland, Ohio, United States, 44111
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- Clinical Study Site
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Mayfield Heights, Ohio, United States, 44124
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
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Pennsylvania
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Lebanon, Pennsylvania, United States, 17042
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Philadelphia, Pennsylvania, United States, 19107
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- Clinical Study Site
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Philadelphia, Pennsylvania, United States, 19111
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Philadelphia, Pennsylvania, United States, 19140
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Pittsburgh, Pennsylvania, United States, 15232
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Pittsburgh, Pennsylvania, United States, 15212
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Sellersville, Pennsylvania, United States, 18960
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Rhode Island
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Providence, Rhode Island, United States, 02903
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South Carolina
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Greenville, South Carolina, United States, 29605
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Spartanburg, South Carolina, United States, 29303
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Tennessee
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Germantown, Tennessee, United States, 38138
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Hermitage, Tennessee, United States, 37129
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Texas
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Dallas, Texas, United States, 75235
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Dallas, Texas, United States, 75390
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77026
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Tyler, Texas, United States, 75701
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Utah
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Salt Lake City, Utah, United States, 84106
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- Clinical Study Site
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Salt Lake City, Utah, United States, 84112
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Vermont
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Burlington, Vermont, United States, 05401
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Virginia
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Charlottesville, Virginia, United States, 22908
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- Clinical Study Site
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Fairfax, Virginia, United States, 22031
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Washington
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Spokane, Washington, United States, 99208
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Tacoma, Washington, United States, 98405
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West Virginia
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Charleston, West Virginia, United States, 25304
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Wisconsin
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Madison, Wisconsin, United States, 53792
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
- Known BRAF V600E mutant status
- Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction
- Ascites requiring paracentesis within last 30 days
- Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer
- Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Resectable disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
|
|
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.
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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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PFS by IRRC based on RECIST v1.1
Time Frame: Up to approximately 2.5 years
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Progression-free survival (PFS) assessed by IRRC per RECIST v1.1
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Up to approximately 2.5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall Survival (OS) in the population
Time Frame: Up to approximately 4 years
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Overall Survival (OS) in the mCRC population
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Up to approximately 4 years
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|
ORR
Time Frame: Up to approximately 2.5 years
|
Efficacy measures such as overall response rate (ORR), which is the proportion of subjects with CR or PR by IRRC based on RECIST v1.1
|
Up to approximately 2.5 years
|
|
Adverse Events (AE)
Time Frame: Up to approximately 4 years
|
incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results [From the time subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/bevacizumab) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first]
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Up to approximately 4 years
|
|
DoR
Time Frame: up to approximately 2.5 years
|
Efficacy measures such as duration of response (DoR), which is the proportion of subjects with CR or PR by IRRC based on RECIST v1.1
|
up to approximately 2.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2025
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
November 30, 2029
Study Registration Dates
First Submitted
November 10, 2025
First Submitted That Met QC Criteria
November 13, 2025
First Posted (Actual)
November 14, 2025
Study Record Updates
Last Update Posted (Actual)
September 8, 2026
Last Update Submitted That Met QC Criteria
September 4, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Colorectal Neoplasms
- Amino Acids, Peptides, and Proteins
- Proteins
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Enzymes and Coenzymes
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Coordination Complexes
- Pyrimidines
- Formyltetrahydrofolates
- Tetrahydrofolates
- Folic Acid
- Pterins
- Pteridines
- Uracil
- Pyrimidinones
- Coenzymes
- Oxaliplatin
- Bevacizumab
- Fluorouracil
- Leucovorin
Other Study ID Numbers
- SMT112-3005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.