RecruitingPHASE3INTERVENTIONAL

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

This research is investigating new treatment options for patients with advanced bowel (colorectal) cancer that has started on the left side of the body and cannot be removed by surgery or has spread. Specifically, it's for people whose cancer cells don't have certain genetic changes (known as KRAS/NRAS and BRAF wild-type). The study aims to see if a new experimental drug, amivantamab, when given with standard chemotherapy (either mFOLFOX6 or FOLFIRI), is better at keeping the disease from getting worse compared to a standard drug, cetuximab, also given with the same chemotherapy combinations. The main goal is to compare how long patients remain free from their disease progressing.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

1,000

Start

18 Oct 2024

Estimated completion

20 Jan 2032

Colorectal Neoplasms

What is this study about?

This study is looking into new potential treatments for a specific type of bowel cancer that has spread or cannot be removed by surgery. This form of cancer is often called advanced colorectal cancer. The doctors running this research want to find out if a new drug called amivantamab, when given alongside standard chemotherapy, can help patients more than the current treatment approach, which involves another drug called cetuximab and chemotherapy.

The researchers are particularly interested in patients whose cancer started on the left side of their bowel and who have specific characteristics in their cancer cells. These characteristics are related to certain genes (KRAS, NRAS, and BRAF) that are 'wild-type,' meaning they don't have particular genetic changes that are sometimes found in cancer cells. This detail is important because different cancer treatments work better for different genetic make-ups of cancer.

The main aim of this study is to compare how long patients stay free from their cancer progressing or getting worse. This is a common way to measure how effective a new cancer treatment is. By participating, patients could help researchers understand if amivantamab offers a better way to manage this type of advanced bowel cancer.

Key takeaways

This study is for advanced bowel cancer that started on the left side.
It's for people whose cancer has specific 'wild-type' genetic features.
It compares a new drug (amivantamab) with a standard drug (cetuximab).
Both drugs are given alongside standard chemotherapy.
The main goal is to see which treatment keeps the cancer from progressing for longer.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

This study is specifically for adults with bowel cancer that started on the left side of their body, and which has either spread to other parts of the body or cannot be removed by surgery. An important factor is that tests on your cancer cells must show that certain genes (KRAS, NRAS, and BRAF) are 'wild-type' – meaning they don't have specific changes.

To be considered, you should not have had any previous drug treatments for your advanced bowel cancer. You also need to be generally well enough to take part, as assessed by your doctor. You'll need to provide a fresh sample of your tumour tissue for analysis.

There are also some reasons why you might not be able to join. For example, if you have certain lung conditions, specific allergies to the study drugs, or a history of other cancers that could interfere with the study. Also, if your cancer has certain other genetic features (like dMMR/MSI-H or HER2-positive) or you've previously had drugs that target specific cancer pathways (like EGFR, MET, or VEGF), you wouldn't 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 bowel cancer that has spread or can't be removed by surgery?
Did your cancer start on the left side of your bowel?
Have tests shown your cancer has specific 'wild-type' KRAS, NRAS, and BRAF genes?
Have you not had previous drug treatment for your advanced bowel cancer?
Are you generally well enough for treatment, as assessed by your doctor?
Do you not have certain lung conditions or specific allergies to the study drugs?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular hospital visits for treatments, check-ups, and tests. You would receive either the investigational drug amivantamab or the standard drug cetuximab, both given with chemotherapy. The chemotherapy would be one of two standard combinations: mFOLFOX6 or FOLFIRI. These treatments are given through a drip.

During your participation, you would have blood tests, scans (like CT scans), and physical examinations to monitor your health and how the treatment is working. The exact schedule of visits and tests would be provided by the study team. You would be followed up regularly for as long as you are on the treatment and potentially for a period afterwards. The total duration of your participation would depend on how your cancer responds to the treatment and your overall health, but it could last for many months.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment (amivantamab) before it's widely available, which may be more effective than existing options. However, there are also potential risks, including side effects from the study drugs, which can be significant and vary from person to person. The research drugs or combinations might not work for you, or they could prove less effective than standard care. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (235)

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

Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States· Recruiting
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
Rocky Mountain Cancer Centers
Verified postcode
Denver, United States· Recruiting
Yale University School Of Medicine
Verified postcode
New Haven, United States· Recruiting

Common questions

What is 'wild-type' cancer?

It means your cancer cells don't have specific genetic changes in certain genes (KRAS, NRAS, and BRAF) that doctors look for.

What is advanced bowel cancer?

This refers to bowel cancer that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable).

What are mFOLFOX6 and FOLFIRI?

These are common combinations of chemotherapy drugs used to treat bowel cancer.

Will I know if I'm getting the new drug or the standard drug?

This is a 'blinded' study, meaning you won't know which drug you are receiving, but your doctor will have this information if medically necessary.

What are the main comparisons in this study?

The study compares how long people live without their disease getting worse when treated with amivantamab plus chemotherapy versus cetuximab plus chemotherapy.

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.