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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSummit Therapeutics

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Drug: Ivonescimab Injection
  • Drug: Bevacizumab Injection

Treatment groups

600 Participants
are divided into 2 treatment groups

Sponsors and collaborators