Early access
Sign in
Taking people in United KingdomPhase 3

Tests ivonescimab with chemotherapy against bevacizumab for colorectal cancer

Compares ivonescimab plus chemotherapy with bevacizumab plus chemotherapy in adults with metastatic colorectal cancer.

Key facts

Who runs it
Summit Therapeutics
Where
Aberdeen, Canterbury, Edinburgh, Liverpool, London, Manchester, and Northwood, United KingdomSee the 7 sitesAlso in 14 other countries, 200 sites
Trial code
Registry title
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
Status
Recruiting
Phase
Phase 3
People taking part
900 people, planned
Started
18 Nov 2025
Expected to end
30 Nov 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Drug: Ivonescimab Injection
  • Drug: Bevacizumab Injection
Record updated
5 November 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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'?

Where in United Kingdom

Also in 14 other countries, 200 sites

  • Aberdeen, ScotlandHospital not named in the registryContact: Ning Chang, MDTaking people
  • Canterbury, EnglandHospital not named in the registryContact: Ning Chang, MDTaking people
  • EdinburghHospital not named in the registryContact: Ning Chang, MDTaking people
  • LiverpoolHospital not named in the registryContact: Ning Chang, MDTaking people
  • London, EnglandHospital not named in the registryContact: Ning Chang, MDTaking people
  • ManchesterHospital not named in the registryContact: Ning Chang, MDTaking people
  • Northwood, MiddlesexHospital not named in the registryContact: Ning Chang, MDTaking people

About the trial

What the trial wants to find out

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)

The 2 groups in the trial

  • Arm A: Ivonescimab in combination with mFOLFOX6Treatment being tested

    Subjects will receive Ivonescimab Plus mFOLFOX6 via intravenous infusion (IV) Q2W, up to 8 cycles. Afterward, Ivonescimab plus Leucovorin and 5-FU will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) up to 2 years.

    Treatment: Drug: Ivonescimab Injection

  • Arm B: Bevacizumab in combination with mFOLFOX6Existing treatment, for comparison

    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. Afterward, bevacizumab Plus 5-FU and Leucovorin will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) up to 2 years.

    Treatment: Drug: Bevacizumab Injection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests ivonescimab with chemotherapy against bevacizumab for colorectal cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07228832, who can take part
Record updated
5 November 2026