Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07228832

Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

Led by Summit Therapeutics · Updated on 2026-05-05

600

Participants Needed

76

Research Sites

210 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ECOG performance status score of 0 or 1
  • Expected life expectancy 65 6 months
  • Histologically or cytologically confirmed metastatic colorectal cancer
  • No prior systemic therapy for metastatic colorectal cancer
  • At least 1 measurable noncerebral lesion
Not Eligible

You will not qualify if you...

  • Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease
  • Known BRAF V600E mutant status
  • Significant radiographic or clinical gastrointestinal obstruction
  • Ascites requiring paracentesis within last 30 days
  • Prior immunotherapy or anti-angiogenic therapy for colorectal cancer
  • Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
  • Resectable disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 76 locations

1

Clinical Study Site

Goodyear, Arizona, United States, 85338

Actively Recruiting

2

Clinical Study Site

Beverly Hills, California, United States, 90211

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3

Clinical Study Site

Beverly Hills, California, United States, 90212

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4

Clinical Study Site

Cerritos, California, United States, 90703

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5

Clinical Study Site

Corona, California, United States, 92882

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6

Clinical Study Site

Duarte, California, United States, 91010

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7

Clinical Study Site

Fountain Valley, California, United States, 92708

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8

Clinical Study Site

Huntington Beach, California, United States, 92648

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9

Clinical Study Site

Irvine, California, United States, 92612

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10

Clinical Study Site

Irvine, California, United States, 92618

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11

Clinical Study Site

Los Angeles, California, United States, 90027

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12

Clinical Study Site

Los Angeles, California, United States, 90067

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13

Clinical Study Site

Los Angeles, California, United States, 90404

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14

Clinical Study Site

Murrieta, California, United States, 92562

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15

Clinical Study Site

Orange, California, United States, 92868

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16

Clinical Study Site

Pasadena, California, United States, 91030

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17

Clinical Study Site

Torrance, California, United States, 90503

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18

Clinical Study Site

Upland, California, United States, 91786

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19

Clinical Study Site

West Hollywood, California, United States, 90048

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20

Clinical Study Site

Hartford, Connecticut, United States, 06106

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21

Clinical Study Site

New Haven, Connecticut, United States, 06520-8028

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22

Clinical Study Site

Norwich, Connecticut, United States, 06360

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23

Clinical Study Site

Hialeah, Florida, United States, 33013

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24

Clinical Study Site

Miami, Florida, United States, 33176

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25

Clinical Study Site

Orlando, Florida, United States, 32806

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26

Clinical Study Site

Plantation, Florida, United States, 33322

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27

Clinical Study Site

Port Saint Lucie, Florida, United States, 34952

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28

Clinical Study Site

Tamarac, Florida, United States, 33321

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29

Clinical Study Site

Newnan, Georgia, United States, 30265

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30

Clinical Study Site

Chicago, Illinois, United States, 60611

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31

Clinical Study Site

Elmhurst, Illinois, United States, 60540

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32

Clinical Study Site

O'Fallon, Illinois, United States, 62269

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33

Clinical Study Site

Fort Wayne, Indiana, United States, 46804

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34

Clinical Study Site

Indianapolis, Indiana, United States, 46202

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35

Clinical Study Site

Edgewood, Kentucky, United States, 41017

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36

Clinical Study Site

Saint Louis Park, Minnesota, United States, 55426

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37

Clinical Study Site

Billings, Montana, United States, 59102

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38

Clinical Study Site

Lincoln, Nebraska, United States, 68506

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39

Clinical Study Site

New Brunswick, New Jersey, United States, 08901

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40

Clinical Study Site

Mineola, New York, United States, 11501

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41

Clinical Study Site

New York, New York, United States, 10016

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42

Clinical Study Site

The Bronx, New York, United States, 10461

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43

Clinical Study Site

Akron, Ohio, United States, 44032

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44

Clinical Study Site

Canton, Ohio, United States, 44703

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45

Clinical Study Site

Cincinnati, Ohio, United States, 45219

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46

Clinical Study Site

Cincinnati, Ohio, United States, 45220

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47

Clinical Study Site

Cleveland, Ohio, United States, 44111

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48

Clinical Study Site

Cleveland, Ohio, United States, 44195

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49

Clinical Study Site

Mayfield Heights, Ohio, United States, 44124

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50

Clinical Study Site

Philadelphia, Pennsylvania, United States, 19111

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51

Clinical Study Site

Philadelphia, Pennsylvania, United States, 19140

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52

Clinical Study Site

Hermitage, Tennessee, United States, 37129

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53

Clinical Study Site

Fort Worth, Texas, United States, 76104

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54

Clinical Study Site

Salt Lake City, Utah, United States, 84106

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55

Clinical Study Site

Charlottesville, Virginia, United States, 22908

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56

Clinical Study Site

Spokane, Washington, United States, 99208

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57

Clinical Study Site

Tacoma, Washington, United States, 98405

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58

Clinical Study Site

Charleston, West Virginia, United States, 25304

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59

Clinical Study Site

Montreal, Quebec, Canada, H4A 3J1

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60

Clinical Study Site

Aichi, Japan, 464-8681

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61

Clinical Study Site

Chiba, Japan, 260-8717

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62

Clinical Study Site

Fukuoka, Japan, 812-8582

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63

Clinical Study Site

Gifu, Japan, 501-1194

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64

Clinical Study Site

Hiroshima, Japan, 734-8551

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65

Clinical Study Site

Hokkaido, Japan, 060-8648

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66

Clinical Study Site

Kawasaki, Japan, 216-8511

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67

Clinical Study Site

Osaka, Japan, 541-8567

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68

Clinical Study Site

Sendai, Japan, 980-0872

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69

Clinical Study Site

Shizuoka, Japan, 411-8777

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70

Clinical Study Site

Tokyo, Japan, 104-0045

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71

Clinical Study Site

Tokyo, Japan, 135-8550

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72

Clinical Study Site

Toyama, Japan, 930-0194

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73

Clinical Study Site

Rio Piedras, Puerto Rico, 00935

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74

Clinical Study Site

Canterbury, England, United Kingdom, CT13NS

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75

Clinical Study Site

London, England, United Kingdom, EC1M 6BQ

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76

Clinical Study Site

Aberdeen, Scotland, United Kingdom, AB25 2ZN

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Research Team

N

Nindhana Paranthaman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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