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

NCT07228832 · Summit Therapeutics
In plain English

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Official title
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
About this study
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.
Eligibility criteria
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
Enrollment target: 600 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-11-18
Estimated completion: 2029-11-30
Last updated: 2026-05-05
Interventions
Drug: Drug: Ivonescimab InjectionDrug: Drug: Bevacizumab Injection
Primary outcomes
  • PFS by IRRC based on RECIST v1.1 (Up to approximately 2.5 years)
Sponsor
Summit Therapeutics · industry
Contacts & investigators
ContactNindhana Paranthaman, MD · contact · medicalaffairs@summitplc.com · 1-833-256-0522
All locations (76)
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Goodyear, Arizona, United States
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Beverly Hills, California, United States
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Beverly Hills, California, United States
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Cerritos, California, United States
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Corona, California, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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Huntington Beach, California, United States
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Irvine, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Murrieta, California, United States
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Orange, California, United States
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Pasadena, California, United States
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Torrance, California, United States
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Upland, California, United States
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West Hollywood, California, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, United States
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Norwich, Connecticut, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Port Saint Lucie, Florida, United States
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Tamarac, Florida, United States
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Newnan, Georgia, United States
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Chicago, Illinois, United States
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Elmhurst, Illinois, United States
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O'Fallon, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Edgewood, Kentucky, United States
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Saint Louis Park, Minnesota, United States
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Billings, Montana, United States
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Lincoln, Nebraska, United States
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New Brunswick, New Jersey, United States
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Mineola, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Akron, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Mayfield Heights, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Hermitage, Tennessee, United States
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Fort Worth, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Charleston, West Virginia, United States
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Montreal, Quebec, Canada
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Aichi, Japan
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Chiba, Japan
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Fukuoka, Japan
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Gifu, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Kawasaki, Japan
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Osaka, Japan
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Sendai, Japan
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Shizuoka, Japan
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Tokyo, Japan
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Tokyo, Japan
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Toyama, Japan
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Rio Piedras, Puerto Rico
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Canterbury, England, United Kingdom
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London, England, United Kingdom
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Aberdeen, Scotland, United Kingdom
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer · TrialPath