Last updated 14 days ago

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

600 patients around the world
Available in Mexico, Puerto Rico, United States
This trial will be performed as a phase 3, randomized, active-controlled, double-blind, multiregional study comparing Ivonescimab in combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in combination with mFOLFOX6 in patients with metastatic colorectal cancer who have not previously received systemic therapy for metastatic disease. Approximately 600 patients will be randomly assigned to the 2 treatment groups in a 1:1 ratio. Each enrolled subject will receive an intravenous infusion of the Ivonescimab/Bevacizumab Plus mFOLFOX6 (Q2W, up to 8 cycles) in treatment periods per the randomization schedule. Afterward, Ivonescimab/ Bevacizumab Plus 5-Fluorouracil and Leucovorin will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) for up to 2 years.
Summit Therapeutics
600Patients around the world

This study is for people with

Colorectal cancer

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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.
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.
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