RecruitingPHASE3INTERVENTIONAL

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

This research study is looking at new ways to treat advanced bowel cancer (colorectal cancer) that has spread or come back, and where standard chemotherapy hasn't been effective. We are comparing a new medication called amivantamab, given along with a common chemotherapy combination called FOLFIRI, against two existing treatments, cetuximab or bevacizumab, also given with FOLFIRI. The main goal is to see if the new combination can help people live longer or keep their cancer under control for a longer time. This study is for people whose cancer has specific genetic features (KRAS/NRAS and BRAF wild-type) that are important for how the treatments work. Participants will be aged 18 or over and will have already received one line of chemotherapy for their advanced cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

700

Start

12 Dec 2024

Estimated completion

13 Apr 2029

Colorectal Neoplasms

What is this study about?

If you or someone you know has advanced bowel cancer that has either spread or come back, and previous chemotherapy hasn't worked, this study might be of interest. Researchers are always looking for better ways to treat cancer, and this study aims to compare a newer drug combination with current standard treatments.

The main idea is to see if adding a new drug called amivantamab to a common chemotherapy mix (named FOLFIRI) works better than adding other established drugs (cetuximab or bevacizumab) to the same FOLFIRI chemotherapy. 'Better' in this case means helping people live longer or stopping their cancer from growing for a longer period. All treatments in this study are given to people whose cancer has specific genetic markers (called KRAS/NRAS and BRAF wild-type status) which help doctors understand how the cancer might respond to certain medicines.

This is a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available. Doctors need to confirm that the new treatment is safe and more effective than existing options. By taking part, you could contribute to important medical knowledge that might help people with bowel cancer in the future.

Key takeaways

Compares a new drug (amivantamab) with existing treatments for advanced bowel cancer.
For people whose cancer has specific genetic features and has progressed after prior chemotherapy.
A 'Phase 3' study, aiming to see if the new combination is more effective.
Involves regular hospital visits for treatment and monitoring.
Participation is voluntary; you can withdraw at any time.

Who may be eligible?

To join this study, you would need to have bowel cancer (adenocarcinoma of the colon or rectum) that has spread, come back, or cannot be removed by surgery. Your cancer must also have specific genetic features (called KRAS/NRAS and BRAF wild-type, without certain common mutations).

You must have already received one type of chemotherapy specifically for your advanced bowel cancer, and the cancer must have shown signs of growing again after that treatment. You also need to be generally well enough to take part in a clinical trial, as assessed by your doctor (an 'ECOG performance status' of 0 or 1).

There are also reasons why you might not be able to join. For example, if you have a history of certain lung conditions, or known severe allergies to the study medications. Also, if you have another serious cancer or a specific type of bowel cancer that might be treated differently (known as dMMR/MSI-H and haven't received immunotherapy), you might not be eligible.

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 you have advanced bowel cancer that has spread or come back?
Has your cancer been tested for specific genetic markers (KRAS/NRAS and BRAF wild-type)?
Have you already received one course of chemotherapy for your advanced cancer, and it's no longer working?
Are you generally well enough to participate in a clinical trial?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to receive one of the study treatments: either amivantamab plus FOLFIRI chemotherapy, or cetuximab/bevacizumab plus FOLFIRI chemotherapy. You wouldn't get to choose which one, as this is decided randomly, like flipping a coin. All treatments involve regular hospital visits for infusions (medication given through a drip).

You would have regular tests, including blood tests and scans (like CT scans), to monitor your cancer and check how you are responding to the treatment. This also helps doctors keep an eye on any side effects. You would continue treatment for as long as it is helping and you are tolerating it well. The study also involves collecting tissue samples, and potentially follow-up after your treatment ends to see how you are doing in the long term. The total duration of your involvement could vary depending on how long you receive treatment and what follow-up is needed.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new and potentially effective treatments not yet widely available, and close medical monitoring. However, there are also potential risks, as new treatments can have side effects that are not fully known or can be more severe than standard care. Some people may not respond to the treatment, or their condition could worsen. You would be fully informed of all known side effects before consenting. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (241)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ironwood Cancer and Research Center
Verified postcode
Chandler, United States· Recruiting
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States· Recruiting
Arizona Oncology Associates PC NAHOA
Verified postcode
Prescott, United States· Completed
St. Bernard's Medical Center
Verified postcode
Jonesboro, United States· Recruiting
Highlands Oncology Group
Verified postcode
Springdale, United States· Recruiting
CBCC Global Research
Verified postcode
Bakersfield, United States· Recruiting
Los Angeles Cancer Network
Verified postcode
Glendale, United States· Recruiting
Cancer and Blood Specialty Clinic
Verified postcode
Los Alamitos, United States· Recruiting
USC Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Recruiting
UCLA
Verified postcode
Santa Monica, United States· Recruiting
Providence Medical Foundation
Verified postcode
Santa Rosa, United States· Recruiting
Torrance Memorial Physicians Network
Verified postcode
Torrance, United States· Recruiting

Common questions

What is FOLFIRI chemotherapy?

FOLFIRI is a standard combination of chemotherapy drugs (5-fluorouracil, leucovorin, and irinotecan) commonly used to treat bowel cancer.

What do KRAS/NRAS and BRAF wild-type mean?

These are specific genetic features found in some bowel cancers. 'Wild-type' means these genes don't have certain common changes, which is important because it means the cancer might respond better to particular targeted treatments.

What is a 'Phase 3' study?

A Phase 3 study is one of the final stages of clinical research. It compares a new treatment with existing standard treatments to confirm if it's safe and more effective before it can be approved for wider use.

Will I definitely receive the new drug, amivantamab?

Not necessarily. Participants will be randomly assigned to either receive amivantamab plus FOLFIRI, or cetuximab/bevacizumab plus FOLFIRI. It's like flipping a coin to decide which treatment you get.

What happens if the treatment doesn't work for me?

Your medical team will closely monitor your condition. If the treatment isn't working or if side effects are too severe, your doctors will discuss other treatment options with you, and you can withdraw from the study at any time.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com 844-434-4210 Official trial record

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