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Purpose

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)

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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:
    • Oxaliplatin
    • Leucovorin
    • 5-Fluorouracil
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:
    • Oxaliplatin
    • Leucovorin
    • 5-Fluorouracil

Recruiting Locations

Clinical Study Site
Goodyear, Arizona 85338

Clinical Study Site
Beverly Hills, California 90211

Clinical Study Site
Beverly Hills, California 90212

Clinical Study Site
Cerritos, California 90703

Clinical Study Site
Corona, California 92882

Clinical Study Site
Duarte, California 91010

Clinical Study Site
Fountain Valley, California 92708

Clinical Study Site
Huntington Beach, California 92648

Clinical Study Site
Irvine, California 92612

Clinical Study Site
Irvine, California 92618

Clinical Study Site
Los Angeles, California 90027

Clinical Study Site
Los Angeles, California 90067

Clinical Study Site
Los Angeles, California 90404

Clinical Study Site
Murrieta, California 92562

Clinical Study Site
Orange, California 92868

Clinical Study Site
Pasadena, California 91030

Clinical Study Site
Torrance, California 90503

Clinical Study Site
Upland, California 91786

Clinical Study Site
West Hollywood, California 90048

Clinical Study Site
Hartford, Connecticut 06106

Clinical Study Site
New Haven, Connecticut 06520-8028

Clinical Study Site
Norwich, Connecticut 06360

Clinical Study Site
Hialeah, Florida 33013

Clinical Study Site
Miami, Florida 33176

Clinical Study Site
Orlando, Florida 32806

Clinical Study Site
Plantation, Florida 33322

Clinical Study Site
Port Saint Lucie, Florida 34952

Clinical Study Site
Tamarac, Florida 33321

Clinical Study Site
Newnan, Georgia 30265

Clinical Study Site
Chicago, Illinois 60611

Clinical Study Site
Elmhurst, Illinois 60540

Clinical Study Site
O'Fallon, Illinois 62269

Clinical Study Site
Fort Wayne, Indiana 46804

Clinical Study Site
Indianapolis, Indiana 46202

Clinical Study Site
Edgewood, Kentucky 41017

Clinical Study Site
Saint Louis Park, Minnesota 55426

Clinical Study Site
Billings, Montana 59102

Clinical Study Site
Lincoln, Nebraska 68506

Clinical Study Site
New Brunswick, New Jersey 08901

Clinical Study Site
Mineola, New York 11501

Clinical Study Site
New York, New York 10016

Clinical Study Site
The Bronx, New York 10461

Clinical Study Site
Akron, Ohio 44032

Clinical Study Site
Canton, Ohio 44703

Clinical Study Site
Cincinnati, Ohio 45219

Clinical Study Site
Cincinnati, Ohio 45220

Clinical Study Site
Cleveland, Ohio 44111

Clinical Study Site
Cleveland, Ohio 44195

Clinical Study Site
Mayfield Heights, Ohio 44124

Clinical Study Site
Philadelphia, Pennsylvania 19111

Clinical Study Site
Philadelphia, Pennsylvania 19140

Clinical Study Site
Hermitage, Tennessee 37129

Clinical Study Site
Fort Worth, Texas 76104

Clinical Study Site
Salt Lake City, Utah 84106

Clinical Study Site
Charlottesville, Virginia 22908

Clinical Study Site
Spokane, Washington 99208

Clinical Study Site
Tacoma, Washington 98405

Clinical Study Site
Charleston, West Virginia 25304

Clinical Study Site
Rio Piedras, Puerto Rico 00935

More Details

NCT ID
NCT07228832
Status
Recruiting
Sponsor
Summit Therapeutics

Study Contact

Nindhana Paranthaman, MD
1-833-256-0522
medicalaffairs@summitplc.com

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.

Notice

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