HARMONi-GI3
Research type
Research Study
Full 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 (HARMONi-GI3)
IRAS ID
1012450
Contact name
David Johnson
Contact email
Sponsor organisation
Summit Therapeutics, Inc
Research summary
This study is looking at a new medicine called ivonescimab to see if it can help people with colorectal cancer which has spread. The people taking part have not yet had treatment for this advanced stage. Doctors want to find out if ivonescimab, when given with standard chemotherapy, works better or is safer than the current standard treatment, which uses a drug called bevacizumab with chemotherapy. If it turns out to be a better treatment, the study may pave the way for the drug to be provided publicly, if all necessary criteria is met.
Ivonescimab is a special kind of drug that blocks the blood supply that tumours need to grow and helps the immune system recognise and attack the cancer. About 600 adults with advanced colorectal cancer from different parts of the world will be in the study. If a patient meets the criteria to be entered into the study, they will randomly be assigned to one of two groups. One group will receive ivonescimab + chemotherapy and the other group will get bevacizumab + chemotherapy. Neither the participant, nor the study doctor will know which treatment group the patient is assigned. This is known as a double-blind clinical trial. Only the pharmacist who will get the medication ready and prepared for treatment will know which group the participant is in.
Participants will attend the hospital for treatment once every two-weeks. The medicine is taken intravenously (like a drip) and participants will be treated as long as the cancer doesn’t spread, side effects aren’t too strong, self-decision to stop the treatment or any other end of treatment criteria. Everyone will have regular scans to see if the cancer is changing. Doctors will continue to check in to see how long people live and what other treatments they receive post-end of study treatment, known as the follow-up period.REC name
London - South East Research Ethics Committee
REC reference
25/LO/0837
Date of REC Opinion
16 Dec 2025
REC opinion
Further Information Favourable Opinion