drugset / Trial / NCT07228832

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

NCT07228832

Phase 3 Recruiting 600 enrolled Summit Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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)

Timeline

Start
2025-11-18
Primary completion
2028-05-31
Completion
2029-11-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody Intravenous
Subject Ivonescimab Monoclonal antibody Intravenous
Background Leucovorin Small molecule Intravenous
Background Oxaliplatin Small molecule Intravenous
Background fluorouracil Small molecule Intravenous

Indications