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

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

Status
Active
Cancer Type
Colon/Rectal Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07228832
Protocol IDs
SMT112-3005 (primary)
NCI-2025-09154
Study Sponsor
Summit Therapeutics

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.

Eligibility

  1. ECOG performance status score of 0 or 1
  2. Expected life expectancy = 6 months
  3. Patients with histologically or cytologically confirmed metastatic CRC
  4. No prior systemic therapy for metastatic CRC
  5. At least 1 measurable noncerebral lesion

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.