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

About

Brief 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)

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

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

Exclusion Criteria:

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