NCT06750094 · Janssen Research & Development, LLC
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
(OrigAMI-3)
What this study is about
The purpose of this study is to compare how long the participants are disease-free (time without the disease getting worse) and and the length of time until a participant dies (how long patients live), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (K
View original scientific description
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (K
Interventions
BIOLOGICAL
Amivantamab
Amivantamab will be administered.
BIOLOGICAL
Cetuximab
Cetuximab will be administered.
BIOLOGICAL
Bevacizumab
Bevacizumab will be administered.
DRUG
5-fluorouracil
5-fluorouracil will be administered as chemotherapy regimen.
DRUG
Leucovorin calcium/Levoleucovorin
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
DRUG
Irinotecan
Irinotecan will be administered as chemotherapy regimen.
Primary outcome measures
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Time frame: Up to 2 years 1 month
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v)1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date.
Overall Survival (OS)
Time frame: Up to 4 years 4 months
OS is defined as the time from the date of randomization to the date of participant's death due to any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
- Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
- Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
- Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
- Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
- Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with do
Where
- Chandler, Arizona
- Gilbert, Arizona
- Prescott, Arizona
- Jonesboro, Arkansas
- Springdale, Arkansas
- Bakersfield, California
- Glendale, California
- Los Alamitos, California
- Los Angeles, California
- Santa Monica, California
- Santa Rosa, California
- Torrance, California
And 50 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations