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

Active:	Yes
Cancer Type:	Colon/Rectal Cancer	NCT ID:	NCT07228832
Trial Phases:	Phase III	Protocol IDs:	SMT112-3005 (primary) NCI-2025-09154
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Summit Therapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT07228832

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)

Objectives

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.

Treatment Sites in Georgia

Emory Johns Creek Hospital
6325 Hospital Parkway
Johns Creek, GA 30097
www.emoryjohnscreek.com

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.