Tests ivonescimab with chemotherapy against bevacizumab for colorectal cancer
Compares ivonescimab plus chemotherapy with bevacizumab plus chemotherapy in adults with metastatic colorectal cancer.
Plain-language title generated from the registry record
Registry title: Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
Key facts
- Where
- Budapest, Debrecen, and Kecskemét, HungarySee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colorectal cancer that has spread, who have not yet had drug treatment for the spread. It compares ivonescimab plus FOLFOX with bevacizumab plus FOLFOX.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Colorectal cancer confirmed by tissue or cell tests that has spread (metastatic). At least 1 measurable lesion outside the brain. The disease cannot be removable by surgery.
- Earlier treatment
- No earlier systemic (whole-body) drug therapy for metastatic colorectal cancer. No earlier immunotherapy or anti-angiogenic therapy for colorectal cancer.
- Biomarker or test result
- Tumours that are MSI-H or dMMR cannot join. Tumours with a known BRAF V600E mutation cannot join.
Main reasons for not taking part
- Tumour is MSI-H or dMMR
- Known BRAF V600E mutation
- Signs of a blocked bowel (gastrointestinal obstruction)
- Fluid in the belly that needed draining within the last 30 days
- Current or past inflammatory bowel disease, such as Crohn's disease, ulcerative colitis or chronic diarrhoea
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How many different drug treatment plans (such as chemotherapy) have you had for cancer that has spread?
- Has a test of your tumour shown a change (mutation) in the KRAS, NRAS or BRAF genes?
- Has a test shown that your tumour is 'MSI-high' or 'dMMR'?
Source: NCT07228832, who can take part
Where in Hungary
- BudapestHospital not named in the registryTaking people
- DebrecenHospital not named in the registryTaking people
- KecskemétHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Summit Therapeutics
- Trial code
- NCT07228832
- Record updated
- 5 November 2026
- Original description
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)Read full original descriptionShow less
A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer
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)
Inclusion: 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: 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); Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease; Resectable 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.