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Phase IIIInterventional

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

Protocol: 2025P013723NCT: NCT07228832

Overview

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)

Eligibility

Ages18 Years and older
SexAll
Healthy VolunteersNo
Age GroupsAdult, Older Adult

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
Investigators
Oluwadunni Emiloju Dr
Locations
Emory University Hospital Midtown
Emory Saint Joseph's Hospital
Emory Johns Creek Hospital
Winship Cancer Institute
View on ClinicalTrials.gov