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RecruitingPHASE3INTERVENTIONAL

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

This important study, called HARMONi-GI3, is looking for a new treatment for bowel cancer that has spread to other parts of the body (metastatic colorectal cancer). Researchers want to find out if a new drug, ivonescimab, works better than a standard treatment, bevacizumab, when given with a common chemotherapy called FOLFOX. Patients in the study will be randomly assigned to receive either ivonescimab or bevacizumab, both with FOLFOX. This is a "Phase 3" study, meaning it's one of the final steps before a new drug might become widely available. The goal is to provide a new and potentially more effective first treatment option for people with this type of cancer.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Summit Therapeutics
Enrolment target
600
Start
18 Nov 2025
Estimated completion
30 Nov 2029

What is this study about?

This study is called HARMONi-GI3 and it's looking into a new way to treat bowel cancer (colorectal cancer) that has spread to other parts of the body, which doctors call 'metastatic'. When cancer spreads, it can be more challenging to treat, so doctors are always searching for new and better medicines.

In this study, researchers are testing a new drug called ivonescimab. They want to see how well it works compared to a treatment that's already commonly used, called bevacizumab. Both of these drugs will be given alongside a standard chemotherapy treatment called FOLFOX. The aim is to find out if ivonescimab, combined with FOLFOX, can be a better first treatment option for people who haven't had other treatments for their metastatic bowel cancer yet.

This is a 'Phase 3' study, which means it’s a large and important step in testing new medicines. It helps doctors understand if a new treatment is safe and effective before it might become more widely available to patients. The study will involve about 600 patients who will be randomly assigned to receive one of the two treatment combinations being compared.

Key takeaways

  • This study is testing a new drug, ivonescimab, for advanced bowel cancer.
  • It compares ivonescimab with a standard drug, bevacizumab, both with chemotherapy.
  • The study is for patients whose bowel cancer has spread and haven't had prior treatment for it.
  • Participation involves regular intravenous treatments and monitoring over a long period.
  • It's a 'Phase 3' study, aiming to find potentially better first-line treatments for metastatic colorectal cancer.

Who may be eligible?

To be able to join this study, your doctor will need to check a few things. You must have bowel cancer that has spread to other parts of your body, and this must be your first time receiving treatment for it. You should also be generally well enough to take part, meaning you can carry out most of your daily activities without much trouble, and doctors expect you to live for at least another six months. Your cancer also needs to have at least one area that can be measured on scans.

There are also some reasons why you might not be able to join. For example, if your bowel cancer has certain genetic markers (like MSI-High, dMMR, or BRAF V600E mutations), you won't be eligible. You also can't have serious bowel blockages or conditions like inflammatory bowel disease (Crohn's or ulcerative colitis). If you've already had certain types of cancer treatment, like immunotherapy or anti-angiogenic therapy, or if your cancer could be completely removed by surgery, you won't be able to join this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have bowel cancer that has spread to other parts of my body?
  2. Have I received other treatments specifically for my spread-out bowel cancer before?
  3. Do I feel well enough to do most of my daily activities?
  4. Do doctors expect me to live for at least another six months?
  5. Do I have certain genetic markers in my cancer, like MSI-High or BRAF V600E?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups, like flipping a coin. Neither you nor your doctor will know which treatment group you are in. Both groups will receive regular treatments given through a drip into your vein.

For the first part of the study, you'll receive your assigned drug (either ivonescimab or bevacizumab) along with a chemotherapy called mFOLFOX6. This will be given every two weeks for up to 8 cycles. After this, you'll continue with a maintenance treatment of your assigned drug plus two chemotherapy drugs (5-Fluorouracil and Leucovorin) every two weeks. This maintenance treatment could last for up to two years. Throughout the study, you'll have regular hospital visits for your treatments, check-ups, and tests to monitor your health and how the treatment is working.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than existing options, or you could contribute to medical knowledge that helps others in the future. However, there's a chance the new treatment might not work as well, or you could experience side effects, some of which might be serious. Your doctors will carefully explain all known side effects and help manage them. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (76)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Clinical Study Site
    Verified postcode
    Goodyear, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Beverly Hills, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Beverly Hills, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Cerritos, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Corona, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Duarte, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Fountain Valley, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Huntington Beach, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Irvine, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Irvine, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Los Angeles, United States· Recruiting
  • Clinical Study Site
    Verified postcode
    Los Angeles, United States· Recruiting

Common questions

What is metastatic colorectal cancer?

This is bowel cancer that has spread from where it started to other parts of the body, such as the liver or lungs.

What does a "Phase 3" study mean?

Phase 3 studies are large trials that compare a new treatment with a standard treatment to see if the new one is better or has fewer side effects. They are usually the final step before a treatment can be approved.

What is FOLFOX?

FOLFOX is a common combination of chemotherapy drugs (Oxaliplatin, Leucovorin, and 5-Fluorouracil) used to treat bowel cancer.

What is a 'double-blind' study?

In a double-blind study, neither you nor your doctor knows which specific treatment you are receiving. This helps make sure the results are fair and unbiased.

How long would I be on the study treatment?

The initial treatment phase lasts for up to 8 cycles (about 4 months), followed by a maintenance treatment that could last for up to two years.

How to find out more

Nindhana Paranthaman, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Phase III Study of Ivonescimab or Bevacizumab Combined With …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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