At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Drug: Ivonescimab Injection (drug), Drug: Bevacizumab Injection (drug)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Drug: Ivonescimab Injection — drug: Subjects will receive Ivonescimab Plus mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) via intravenous infusion (IV) Q2W, up to 8 cycles. · Drug: Bevacizumab Injection — drug: Subjects will receive bevacizumab Plus mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) via intravenous infusion (IV) Q2W, up to 8 cycles in treatment periods per the randomization schedule.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 600
- Started
- 2025-11-18
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic colorectal cancer (crc)
- • Phase3 - 600 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic colorectal cancer (crc)
Where?
- • Canterbury - Clinical Study Site
- • London - Clinical Study Site
- • Aberdeen - Clinical Study Site
- • Edinburgh - Clinical Study Site
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
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)
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓ECOG performance status score of 0 or 1
- ✓Expected life expectancy ≥ 6 months
- ✓Patients with confirmed by testing a sample that has spread CRC
- ✓No prior treatment that goes through your whole body for that has spread CRC
- ✓At least 1 measurable noncerebral lesion
Who cannot take part
- ✗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 treatment that helps your immune system fight cancer or anti-angiogenic therapy for colorectal cancer
See the full criteria
Where Is This Study? (6 UK sites)
Clinical Study Site
Canterbury CT13NS, United Kingdom
Clinical Study Site
London EC1M 6BQ, United Kingdom
Clinical Study Site
Aberdeen AB25 2ZN, United Kingdom
Clinical Study Site
Edinburgh EH4 2XU, United Kingdom
Clinical Study Site
Liverpool L7 8YA, United Kingdom
Clinical Study Site
Manchester M20 4BX, United Kingdom
How to Get in Touch
Ning Chang, MD
Sponsor contactCONTACT