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

Recruiting now · Phase 3

Conditions studied: Metastatic Colorectal Cancer (CRC)

In brief

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)

Key facts

Study ID

NCT07228832

Run by

Summit Therapeutics

People needed

600

Starts

2025-11-18

Expected to finish

2029-11-30

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Study Site — Tuscaloosa, Alabama, United States (enrolling)
• Clinical Study Site — Goodyear, Arizona, United States (enrolling)
• Clinical Study Site — Beverly Hills, California, United States (enrolling)
• Clinical Study Site — Beverly Hills, California, United States (enrolling)
• Clinical Study Site — Cerritos, California, United States (enrolling)
• Clinical Study Site — Corona, California, United States (enrolling)
• Clinical Study Site — Duarte, California, United States (enrolling)
• Clinical Study Site — Fountain Valley, California, United States (enrolling)
• Clinical Study Site — Huntington Beach, California, United States (enrolling)
• Clinical Study Site — Irvine, California, United States (enrolling)
• Clinical Study Site — Irvine, California, United States (enrolling)
• Clinical Study Site — Los Angeles, California, United States (enrolling)
• Clinical Study Site — Los Angeles, California, United States (enrolling)
• Clinical Study Site — Los Angeles, California, United States (enrolling)
• Clinical Study Site — Murrieta, California, United States (enrolling)
• Clinical Study Site — Oakland, California, United States (enrolling)
• Clinical Study Site — Orange, California, United States (enrolling)
• Clinical Study Site — Pasadena, California, United States (enrolling)
• Clinical Study Site — Roseville, California, United States (enrolling)
• Clinical Study Site — San Francisco, California, United States (enrolling)
• Clinical Study Site — Santa Clara, California, United States (enrolling)
• Clinical Study Site — Stanford, California, United States (enrolling)
• Clinical Study Site — Torrance, California, United States (enrolling)
• Clinical Study Site — Upland, California, United States (enrolling)
• Clinical Study Site — Mobile, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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