Amivantamab + Chemotherapy for Colorectal Cancer
(OrigAMI-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new medicine called amivantamab on patients with advanced colorectal cancer. The medicine helps the immune system find and destroy cancer cells. Researchers want to see how well it works alone and with standard chemotherapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is the combination of Amivantamab and chemotherapy safe for treating colorectal cancer?
The safety of chemotherapy combinations like 5-fluorouracil (5-FU), leucovorin, irinotecan, and oxaliplatin has been studied in colorectal cancer, showing they are generally safe with manageable side effects. However, specific safety data for Amivantamab combined with these chemotherapies in colorectal cancer is not provided in the available research.12345
What makes the drug Amivantamab + Chemotherapy unique for colorectal cancer?
This treatment combines Amivantamab, a novel drug targeting specific cancer cell pathways, with established chemotherapy agents like Fluorouracil, Irinotecan, Leucovorin, and Oxaliplatin, which are standard in colorectal cancer treatment. The inclusion of Amivantamab, which is not typically used for colorectal cancer, may offer a new approach by potentially enhancing the effectiveness of the chemotherapy regimen.678910
What data supports the effectiveness of the drug combination Amivantamab + Chemotherapy for Colorectal Cancer?
Research shows that combinations of chemotherapy drugs like fluorouracil (5-FU), leucovorin, oxaliplatin, and irinotecan have improved survival rates in colorectal cancer patients. These combinations are standard treatments and have shown to be effective in both early and advanced stages of the disease.3791112
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 advanced colorectal cancer that can't be removed by surgery or has spread. They must have a specific performance status, agree to a tumor biopsy, and not be pregnant. People with certain genetic mutations or brain metastasis are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive amivantamab monotherapy or in combination with standard-of-care chemotherapy in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Fluorouracil
- Irinotecan
- Leucovorin
- Oxaliplatin
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