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?
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.
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.
What safety information is available for Cetuximab in colorectal cancer treatment?
What makes the drug combination of Amivantamab and Cetuximab with chemotherapy unique for colorectal cancer?
The combination of Amivantamab and Cetuximab with chemotherapy is unique because it involves two monoclonal antibodies targeting different pathways: Amivantamab targets the MET and EGFR pathways, while Cetuximab specifically targets the EGFR pathway. This dual targeting approach may offer a novel mechanism to enhance antitumor activity compared to standard treatments that typically focus on a single pathway.34678
What data supports the effectiveness of the drug Cetuximab when used with chemotherapy for colorectal cancer?
Cetuximab, when combined with chemotherapy, has shown promising results in treating metastatic colorectal cancer, improving progression-free survival and response rates. It has been effective in patients who have previously been treated with other chemotherapy drugs, restoring sensitivity to irinotecan and enhancing the overall treatment effect.236910
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:
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