Amivantamab + Chemotherapy vs Cetuximab + Chemotherapy for Colorectal Cancer
(OrigAMI-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how long individuals with a specific type of colorectal cancer can remain disease-free when treated with different drug combinations. One group will receive amivantamab (a monoclonal antibody) with chemotherapy, while another group will receive cetuximab (another monoclonal antibody) with chemotherapy. The trial focuses on individuals with left-sided colorectal cancer that cannot be surgically removed or has metastasized, and who have specific genetic profiles (KRAS, NRAS, and BRAF wild-type). Participants must have a confirmed diagnosis of this cancer type that impacts their daily life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that amivantamab, when combined with chemotherapy, has helped about 49% of people with metastatic colorectal cancer experience some tumor shrinkage. Nearly half of the patients saw their tumors get smaller. Testing has confirmed its safety both on its own and with standard chemotherapy. Results suggest it is generally well-tolerated, though, like any treatment, it can have side effects.
Cetuximab is an approved treatment for certain colorectal cancers. Studies have found it is usually well-tolerated, but serious side effects, such as infusion reactions, occurred in about 3% of patients. These reactions can be severe, so discussing them with a healthcare provider is important.
Both treatments have undergone safety studies. Those considering joining a trial should discuss the possible risks and benefits with a doctor.12345Why are researchers excited about this trial's treatments?
Researchers are excited about amivantamab for colorectal cancer because it offers a novel approach by targeting both the EGFR and MET pathways, which are often involved in cancer growth and resistance to treatment. This dual targeting could potentially overcome some of the limitations of current therapies, such as cetuximab, which primarily focuses on the EGFR pathway alone. Additionally, amivantamab is an antibody treatment, providing a new active ingredient that could enhance treatment effectiveness compared to existing options. This combination of mechanisms gives hope for improved outcomes for patients facing this challenging condition.
What evidence suggests that this trial's treatments could be effective for colorectal cancer?
This trial will compare two treatment options for colorectal cancer. Studies have shown that amivantamab, which participants in this trial may receive with chemotherapy, helps nearly half of the patients with metastatic colorectal cancer by reducing their cancer. In another study, patients taking amivantamab with chemotherapy had stable cancer for about 5.7 months on average, meaning the cancer did not worsen during this time. Meanwhile, cetuximab, another treatment option in this trial used with chemotherapy, has been shown to help patients with advanced colorectal cancer live longer. However, about 30% of patients with cancer on the left side of the colon do not respond to cetuximab, meaning their cancer does not shrink or slow down. Both treatments offer hope, but their effectiveness can vary from person to person.12678
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for adults with left-sided colorectal cancer that's spread and can't be removed by surgery. They must have a type of tumor without certain mutations (KRAS/NRAS/BRAF wild-type), be able to provide a fresh tissue sample, have measurable disease, and be in good physical condition (ECOG 0 or 1).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive amivantamab or cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-day treatment cycles until disease progression or other discontinuation criteria are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Cetuximab
Amivantamab is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University