RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

This study is investigating new treatment options for people with advanced bowel (colorectal) cancer that has not spread extensively and cannot be removed by surgery. It aims to see if adding two new medications, ONO-4578 and Opdivo®, to a common treatment plan (mFOLFOX6 and bevacizumab) works better and is safe, compared to the standard treatment alone. This research is for individuals whose cancer has a specific marker known as PD-L1. The study is in its 'Phase 2' stage, meaning it's still in the earlier steps of testing effectiveness and safety in a larger group of people. Participants will receive treatment in cycles and be monitored closely.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Ono Pharmaceutical Co., Ltd.

Enrolment target

144

Start

18 Nov 2025

Estimated completion

01 Oct 2028

Colorectal Cancer

What is this study about?

This research study is looking into a new way to treat advanced bowel cancer which hasn't spread widely and can't be cured by surgery. We know that bowel cancer can be a challenging condition, and doctors are always searching for better treatments.

The main aim of this study is to see if adding two specific drugs, ONO-4578 and Opdivo®, to a standard treatment plan (which includes medicines like Oxaliplatin, 5-Fluorouracil, Bevacizumab, and Leucovorin) is more effective and safer than the standard treatment by itself. It's a 'Phase 2' study, which means it's testing these new combinations in a group of people to gather more information about how well they work and their possible side effects.

The researchers are particularly interested in people whose cancer cells show a specific protein called PD-L1. This study is important because it could lead to new and improved treatment options for people living with this type of advanced bowel cancer.

Key takeaways

This study is for advanced bowel cancer where surgery is not an option.
It tests new drug combinations alongside standard treatment.
Only for people whose cancer has a specific marker called PD-L1.
Treatment involves cycles and regular monitoring.
Participation is voluntary, and you can leave at any time.

Who may be eligible?

To be part of this study, you must have advanced bowel cancer that can't be removed by surgery and hasn't had previous treatment for its advanced stage. Your cancer cells must also have a specific marker called PD-L1. It's important that you are generally well enough to take part, as assessed by your doctor.

There are also some reasons why you might not be able to join. For example, if your cancer has certain genetic features called MSI-High, dMMR, or a BRAF V600E mutation. You also can't have certain other health conditions, like serious lung disease or an active autoimmune disease. Because the trial is testing new drugs, you can't have had similar immune-focused treatments in the past. You also need to be able to swallow tablets.

Your study doctor will carefully go through all the requirements with you to see if this study is a good fit for your situation.

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.

Do I have advanced bowel cancer that cannot be removed by surgery?
Has my bowel cancer started in a new place or spread, and I haven't had treatment for this stage yet?
Has my doctor confirmed my cancer cells have the PD-L1 marker?
Am I generally well and able to get around, as assessed by my doctor?
Do I have any serious lung conditions or active autoimmune diseases?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have some health checks to make sure the study is right for you. If you qualify, you'll be randomly placed into one of three treatment groups. This is like flipping a coin to decide, making sure the study is fair. You will receive treatment every 28 days, which is called a treatment cycle.

These treatment cycles will continue for as long as the treatment is helping, or until you experience side effects that are too uncomfortable, or if you decide you no longer wish to participate. Your study doctor might also decide to stop the treatment for medical reasons, or the study itself could end. Throughout your time in the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to new treatments that aren't yet widely available. However, there are also potential risks involved, including side effects from the study medications. These side effects can vary from mild to more serious, and the study team will discuss all known and potential risks with you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (33)

Mayo Clinic Arizona
Verified postcode
Phoenix, United States· Recruiting
USC Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Recruiting
Rocky Mountain Cancer Centers, LLP
Verified postcode
Lone Tree, United States· Recruiting
Mayo Clinic Florida
Verified postcode
Jacksonville, United States· Recruiting
Advent Health
Verified postcode
Orlando, United States· Recruiting
May Clinic Rochester
Verified postcode
Rochester, United States· Recruiting
The Ohio State University Comprehensive Cancer Center
Verified postcode
Columbus, United States· Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center
Verified postcode
Philadelphia, United States· Recruiting
Baylor Scott & White Medical Center
Verified postcode
Temple, United States· Recruiting
Virginia Oncology Associates
Verified postcode
Norfolk, United States· Recruiting
Blue Ridge Cancer Care
Verified postcode
Salem, United States· Recruiting
Princess Margaret Cancer Centre- University Health Network
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'Phase 2' in a clinical study?

Phase 2 means the study is looking at whether the new treatment is effective and safe in a larger group of people, after earlier tests have shown it to be safe.

What does 'PD-L1 positive' mean for my cancer?

Some cancers have a specific protein called PD-L1 on their surface. This study is specifically for people whose bowel cancer has this protein.

Will I know which treatment group I'm in?

In this study, participants are randomly assigned to one of three groups. This is to ensure fair comparison, and often you won't know which specific combination you are receiving upfront.

What happens if the treatment causes bad side effects?

The study team will monitor you very closely. If you experience significant side effects, your treatment may be adjusted or stopped, and you will receive care to manage your symptoms.

How long will I be in the study?

You will receive treatment in 28-day cycles for as long as it is helping you, or until other reasons, like uncomfortable side effects, mean you need to stop.

How to find out more

North America Clinical Trial Support Desk

clinical_trial@ono-pharma.com +18665877745(Toll-Free) Official trial record

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