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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Recruiting
        • Clinical Study Site
      • Ghent, Belgium, 9000
        • Recruiting
        • Clinical Study Site
      • Haine-Saint-Paul, Belgium, 7100
        • Recruiting
        • Clinical Study Site
      • Kortrijk, Belgium, 8500
        • Recruiting
        • Clinical Study Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Clinical Study Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Clinical Study Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T7T1
        • Recruiting
        • Clinical Study Site
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Recruiting
        • Clinical Study Site
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Clinical Study Site
      • Guangzhou, Fujian, China, 350004
        • Recruiting
        • Clinical Study Site
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • Clinical Study Site
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Clinical Study Site
      • Shenzhen, Guangdong, China, 518101
        • Recruiting
        • Clinical Study Site
    • Hainan
      • Haikou, Hainan, China, 570145
        • Recruiting
        • Clinical Study Site
    • Hebei
      • Shijiazhuang, Hebei, China, 50011
        • Recruiting
        • Clinical Study Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Clinical Study Site
    • Henan
      • Fuzhou, Henan, China, 455000
        • Recruiting
        • Clinical Study Site
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Clinical Study Site
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Clinical Study Site
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Clinical Study Site
      • Yueyang, Hunan, China, 414020
        • Recruiting
        • Clinical Study Site
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 24000
        • Recruiting
        • Clinical Study Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Clinical Study Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Clinical Study Site
    • Jilin
      • Ch’ang-ch’un, Jilin, China, 130012
        • Recruiting
        • Clinical Study Site
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • Clinical Study Site
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Clinical Study Site
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Clinical Study Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Clinical Study Site
      • Luzhou, Sichuan, China, 646000
        • Recruiting
        • Clinical Study Site
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Recruiting
        • Clinical Study Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Clinical Study Site
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Clinical Study Site
      • Ningbo, Zhejiang, China, 315040
        • Recruiting
        • Clinical Study Site
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • Clinical Study Site
  • Czechia
      • Hradec Králové, Czechia, 50005
        • Recruiting
        • Clinical Study Site
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Clinical Study Site
      • Prague, Czechia, 14059
        • Recruiting
        • Clinical Study Site
      • Prague, Czechia, 128 00
        • Recruiting
        • Clinical Study Site
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Clinical Study Site
      • Lille, France, 59000
        • Recruiting
        • Clinical Study Site
      • Lyon, France, 69374
        • Recruiting
        • Clinical Study Site
      • Montpellier, France, 34298
        • Recruiting
        • Clinical Study Site
      • Nantes, France, 44000
        • Recruiting
        • Clinical Study Site
      • Nice, France, 06189
        • Recruiting
        • Clinical Study Site
      • Paris, France, 75020
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        • Clinical Study Site
      • Paris, France, 75015
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        • Clinical Study Site
      • Pierre-Bénite, France, 69495
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        • Clinical Study Site
      • Poitiers, France, 86000
        • Recruiting
        • Clinical Study Site
      • Strasbourg, France, 67033
        • Recruiting
        • Clinical Study Site
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Clinical Study Site
      • Bonn, Germany, 53113
        • Recruiting
        • Clinical Study Site
      • Hamburg, Germany, 22763
        • Recruiting
        • Clinical Study Site
      • Hamburg, Germany, 20249
        • Recruiting
        • Clinical Study Site
  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Clinical Study Site
      • Debrecen, Hungary, 4032
        • Recruiting
        • Clinical Study Site
      • Kecskemét, Hungary, H-6000
        • Recruiting
        • Clinical Study Site
  • Italy
      • Brescia, Italy, 25124
        • Recruiting
        • Clinical Study Site
      • Florence, Italy, 50134
        • Recruiting
        • Clinical Study Site
      • Genova, Italy, 16132
        • Recruiting
        • Clinical Study Site
      • Meldola, Italy, 47014
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        • Clinical Study Site
      • Pisa, Italy, 56126
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        • Clinical Study Site
      • Verona, Italy, 37134
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  • Japan
      • Aichi, Japan, 464-8681
        • Recruiting
        • Clinical Study Site
      • Chiba, Japan, 260-8717
        • Recruiting
        • Clinical Study Site
      • Ehime, Japan, 791-0280
        • Recruiting
        • Clinical Study Site
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Clinical Study Site
      • Gifu, Japan, 501-1194
        • Recruiting
        • Clinical Study Site
      • Hiroshima, Japan, 734-8551
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        • Clinical Study Site
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • Clinical Study Site
      • Kawasaki, Japan, 216-8511
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        • Clinical Study Site
      • Osaka, Japan, 541-8567
        • Recruiting
        • Clinical Study Site
      • Saitama, Japan, 362-0806
        • Recruiting
        • Clinical Study Site
      • Sendai, Japan, 980-0872
        • Recruiting
        • Clinical Study Site
      • Shizuoka, Japan, 411-8777
        • Recruiting
        • Clinical Study Site
      • Tokyo, Japan, 104-0045
        • Recruiting
        • Clinical Study Site
      • Tokyo, Japan, 135-8550
        • Recruiting
        • Clinical Study Site
      • Tokyo, Japan, 113-8677
        • Recruiting
        • Clinical Study Site
      • Toyama, Japan, 930-0194
        • Recruiting
        • Clinical Study Site
      • Yokohama, Japan, 241-8515
        • Recruiting
        • Clinical Study Site
    • Ontario
      • Osaka, Ontario, Japan, 565-0871
        • Recruiting
        • Clinical Study Site
  • Poland
      • Gdansk, Poland, 80-219
        • Recruiting
        • Clinical Study Site
      • Olsztyn, Poland, 10-228
        • Recruiting
        • Clinical Study Site
      • Otwock, Poland, 05-400
        • Recruiting
        • Clinical Study Site
      • Warsaw, Poland, 04-141
        • Recruiting
        • Clinical Study Site
      • Warsaw, Poland, 02-781
        • Recruiting
        • Clinical Study Site
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-021
        • Recruiting
        • Clinical Study Site
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Clinical Study Site
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Clinical Study Site
      • Barcelona, Spain, 08035
        • Recruiting
        • Clinical Study Site
      • Barcelona, Spain, 08916
        • Recruiting
        • Clinical Study Site
      • Barcelona, Spain, 08908
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        • Clinical Study Site
      • Barcelona, Spain, 08036
        • Recruiting
        • Clinical Study Site
      • Granada, Spain, 18014
        • Recruiting
        • Clinical Study Site
      • Madrid, Spain, 28222
        • Recruiting
        • Clinical Study Site
      • Madrid, Spain, 28046
        • Recruiting
        • Clinical Study Site
      • Madrid, Spain, 28009
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        • Clinical Study Site
      • Madrid, Spain, 28050
        • Recruiting
        • Clinical Study Site
      • Málaga, Spain, 29010
        • Recruiting
        • Clinical Study Site
      • Palma de Mallorca, Spain, 07198
        • Recruiting
        • Clinical Study Site
      • Santander, Spain, 39008
        • Recruiting
        • Clinical Study Site
      • Seville, Spain, 41013
        • Recruiting
        • Clinical Study Site
      • Valencia, Spain, 46014
        • Recruiting
        • Clinical Study Site
      • Valencia, Spain, 46026
        • Recruiting
        • Clinical Study Site
      • Valencia, Spain, 46010
        • Recruiting
        • Clinical Study Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • Clinical Study Site
      • Liverpool, United Kingdom, L7 8YA
        • Recruiting
        • Clinical Study Site
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Clinical Study Site
    • England
      • Canterbury, England, United Kingdom, CT13NS
        • Recruiting
        • Clinical Study Site
      • London, England, United Kingdom, EC1M 6BQ
        • Recruiting
        • Clinical Study Site
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Recruiting
        • Clinical Study Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • Clinical Study Site
      • Tuscaloosa, Alabama, United States, 35487
        • Recruiting
        • Clinical Study Site
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Recruiting
        • Clinical Study Site
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Clinical Study Site
      • Beverly Hills, California, United States, 90212
        • Recruiting
        • Clinical Study Site
      • Cerritos, California, United States, 90703
        • Recruiting
        • Clinical Study Site
      • Corona, California, United States, 92882
        • Recruiting
        • Clinical Study Site
      • Duarte, California, United States, 91010
        • Recruiting
        • Clinical Study Site
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Clinical Study Site
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Clinical Study Site
      • Irvine, California, United States, 92612
        • Recruiting
        • Clinical Study Site
      • Irvine, California, United States, 92618
        • Recruiting
        • Clinical Study Site
      • Los Angeles, California, United States, 90027
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        • Clinical Study Site
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Clinical Study Site
      • Los Angeles, California, United States, 90404
        • Recruiting
        • Clinical Study Site
      • Murrieta, California, United States, 92562
        • Recruiting
        • Clinical Study Site
      • Oakland, California, United States, 94611
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        • Clinical Study Site
      • Orange, California, United States, 92868
        • Recruiting
        • Clinical Study Site
      • Pasadena, California, United States, 91030
        • Recruiting
        • Clinical Study Site
      • Roseville, California, United States, 95661
        • Recruiting
        • Clinical Study Site
      • San Francisco, California, United States, 94115
        • Recruiting
        • Clinical Study Site
      • Santa Clara, California, United States, 94115
        • Recruiting
        • Clinical Study Site
      • Stanford, California, United States, 94305
        • Recruiting
        • Clinical Study Site
      • Torrance, California, United States, 90503
        • Recruiting
        • Clinical Study Site
      • Upland, California, United States, 91786
        • Recruiting
        • Clinical Study Site
      • Vallejo, California, United States, 94589
        • Recruiting
        • Clinical Study Site
      • West Hollywood, California, United States, 90048
        • Recruiting
        • Clinical Study Site
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Clinical Study Site
      • New Haven, Connecticut, United States, 06520-8028
        • Recruiting
        • Clinical Study Site
      • Norwich, Connecticut, United States, 06360
        • Recruiting
        • Clinical Study Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Clinical Study Site
    • Florida
      • Hialeah, Florida, United States, 33013
        • Recruiting
        • Clinical Study Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Clinical Study Site
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Clinical Study Site
      • Ocala, Florida, United States, 34474
        • Recruiting
        • Clinical Study Site
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Clinical Study Site
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Clinical Study Site
      • Plantation, Florida, United States, 33322
        • Recruiting
        • Clinical Study Site
      • Port Saint Lucie, Florida, United States, 34952
        • Recruiting
        • Clinical Study Site
      • St. Petersburg, Florida, United States, 33705
        • Recruiting
        • Clinical Study Site
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Clinical Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Clinical Study Site
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Clinical Study Site
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • Clinical Study Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Clinical Study Site
      • Elmhurst, Illinois, United States, 60540
        • Recruiting
        • Clinical Study Site
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Clinical Study Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Clinical Study Site
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Clinical Study Site
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • Clinical Study Site
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • Clinical Study Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Clinical Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Clinical Study Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Clinical Study Site
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Recruiting
        • Clinical Study Site
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Clinical Study Site
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • Clinical Study Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • Clinical Study Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Recruiting
        • Clinical Study Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Clinical Study Site
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Clinical Study Site
      • New York, New York, United States, 10016
        • Recruiting
        • Clinical Study Site
      • Rochester, New York, United States, 14642
        • Recruiting
        • Clinical Study Site
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Clinical Study Site
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Clinical Study Site
      • White Plains, New York, United States, 10601-5000
        • Recruiting
        • Clinical Study Site
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • Clinical Study Site
    • Ohio
      • Akron, Ohio, United States, 44032
        • Recruiting
        • Clinical Study Site
      • Canton, Ohio, United States, 44703
        • Recruiting
        • Clinical Study Site
      • Cincinnati, Ohio, United States, 45219
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        • Clinical Study Site
      • Cincinnati, Ohio, United States, 45220
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        • Clinical Study Site
      • Cleveland, Ohio, United States, 44195
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        • Clinical Study Site
      • Cleveland, Ohio, United States, 44111
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        • Clinical Study Site
      • Mayfield Heights, Ohio, United States, 44124
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        • Clinical Study Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Clinical Study Site
    • Pennsylvania
      • Lebanon, Pennsylvania, United States, 17042
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        • Clinical Study Site
      • Philadelphia, Pennsylvania, United States, 19107
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        • Clinical Study Site
      • Philadelphia, Pennsylvania, United States, 19111
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        • Clinical Study Site
      • Philadelphia, Pennsylvania, United States, 19140
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        • Clinical Study Site
      • Pittsburgh, Pennsylvania, United States, 15232
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        • Clinical Study Site
      • Pittsburgh, Pennsylvania, United States, 15212
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        • Clinical Study Site
      • Sellersville, Pennsylvania, United States, 18960
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        • Clinical Study Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Clinical Study Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
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        • Clinical Study Site
      • Spartanburg, South Carolina, United States, 29303
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    • Tennessee
      • Germantown, Tennessee, United States, 38138
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        • Clinical Study Site
      • Hermitage, Tennessee, United States, 37129
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    • Texas
      • Dallas, Texas, United States, 75235
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        • Clinical Study Site
      • Dallas, Texas, United States, 75390
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        • Clinical Study Site
      • Fort Worth, Texas, United States, 76104
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        • Clinical Study Site
      • Houston, Texas, United States, 77030
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        • Clinical Study Site
      • Houston, Texas, United States, 77026
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        • Clinical Study Site
      • Tyler, Texas, United States, 75701
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    • Utah
      • Salt Lake City, Utah, United States, 84106
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        • Clinical Study Site
      • Salt Lake City, Utah, United States, 84112
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    • Vermont
      • Burlington, Vermont, United States, 05401
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    • Virginia
      • Charlottesville, Virginia, United States, 22908
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        • Clinical Study Site
      • Fairfax, Virginia, United States, 22031
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    • Washington
      • Spokane, Washington, United States, 99208
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        • Clinical Study Site
      • Tacoma, Washington, United States, 98405
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    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
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    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • Clinical Study Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ECOG performance status score of 0 or 1
  2. Expected life expectancy ≥ 6 months
  3. Patients with histologically or cytologically confirmed metastatic CRC
  4. No prior systemic therapy for metastatic CRC
  5. At least 1 measurable noncerebral lesion

Exclusion Criteria:

  1. Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
  2. Known BRAF V600E mutant status
  3. Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction
  4. Ascites requiring paracentesis within last 30 days
  5. Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer
  6. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  7. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: 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.
Other Names:
  • Leucovorin
  • 5-Fluorouracil
  • Oxaliplatin
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.
Drug: 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.
Other Names:
  • Leucovorin
  • 5-Fluorouracil
  • Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PFS by IRRC based on RECIST v1.1
Time Frame: Up to approximately 2.5 years
Progression-free survival (PFS) assessed by IRRC per RECIST v1.1
Up to approximately 2.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in the population
Time Frame: Up to approximately 4 years
Overall Survival (OS) in the mCRC population
Up to approximately 4 years
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]
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Summit Therapeutics

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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