A Phase 3 interventional study of Amivantamab and Cetuximab in Colorectal Neoplasms, sponsored by Janssen Research & Development, LLC. Recruiting at 239 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
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Among 2,338 studies in Colorectal Neoplasms with a site in United States — 419 open to participants now, 628 under way, 30 of them phase 3. Colorectal Neoplasms · United States.
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, this one is the 144th largest by planned enrollment of the 1,931 interventional ones that give a count, is one of 124 that started in 2024, is one of 117 in phase 3, reaches primary completion later than 488 of the 626 other live ones, and was the 2,084th registered.
6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.
Browse Colorectal Neoplasms studies →419 of the 2,338 studies in Colorectal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
Exelixis · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 40–80 · Men only
University of Pennsylvania · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,338 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 817 · Phase 2 790 · Phase 3 132 · Phase 4 19
First in 1981; this study’s year is marked. 124 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 76 across 4,802 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 64 across the 1,931 interventional studies, 221 across the 324 observational. Of the 1,563 that completed or were terminated, 549 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
885 of 2,338 have an industry lead sponsor. The 10 most frequent:
This study is registered under Janssen Research & Development, LLC, one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 137 (48%) have results posted.
Johnson & Johnson has 9 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
227 of the studies in Colorectal Neoplasms with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05141721Phase 3Seattle Project CorporationA Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer | 2027-03 |
| NCT04428905Phase 3City of Hope Medical CenterSelf-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer | 2027-03-31 |
| NCT02997228Phase 3National Cancer Institute (NCI)Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study | 2027-06-01 |
| NCT01349881Phase 3SWOG Cancer Research NetworkS0820, Adenoma and Second Primary Prevention Trial | 2027-09-15 |
| NCT03796884Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityLinaclotide in Treating Patients With Stages 0-3 Colorectal Cancer | 2026-11 |
Add all 227 to your calendar (.ics) → With an account.
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive amivantamab in combination with chemotherapy (mFOLFOX6 \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin\] or FOLFIRI \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride\]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
Biological: Amivantamab · Drug: 5-fluorouracil · Drug: Leucovorin calcium/Levoleucovorin · Drug: Oxaliplatin · Drug: Irinotecan Hydrochloride
Participants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
Biological: Cetuximab · Drug: 5-fluorouracil · Drug: Leucovorin calcium/Levoleucovorin · Drug: Oxaliplatin · Drug: Irinotecan Hydrochloride
Amivantamab will be administered.
Also known as: JNJ-61186372
Cetuximab will be administered.
Also known as: Erbitux
5-fluorouracil will be administered as chemotherapy regimen.
Drug pages: Leucovorin · Levoleucovorin
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Oxaliplatin will be administered as chemotherapy regimen.
Irinotecan hydrochloride will be administered as chemotherapy regimen.
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
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.
Time frame: Up to 4 years and 2 months
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of participant's death due to any cause. Any participant not known to have died at the time of analysis will be censored based on the last recorded date on which the participant was known to be alive.
Time frame: Up to 7 Years 3 Months
Objective Response Rate (ORR) as Assessed by BICR
ORR is defined as the proportion of randomized participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria. BOR is defined as best response recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent systemic anti cancer therapy or date of curative-intent procedure, whichever occurs first.
Time frame: Up to 7 Years 3 Months
Objective Response Rate (ORR) as Assessed by Investigator
ORR is defined as the percentage of randomized participants achieving complete CR or PR, as assessed by the investigator.
Time frame: Up to 7 Years 3 Months
Progression Free Survival (PFS) as Assessed by Investigator
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 the investigator. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable disease assessment date.
Time frame: Up to 7 Years 3 Months
Duration of Response (DOR) as Assessed by BICR
DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by BICR using RECIST v1.1 criteria.
Time frame: Up to 7 Years 3 Months
Duration of Response (DOR) as Assessed Investigator
DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by the investigator.
Time frame: Up to 7 Years 3 Months
Time to Response (TTR) as Assessed by BICR
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by BICR.
Time frame: Up to 7 Years 3 Months
Time to Response as Assessed by Investigator
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by investigator.
Time frame: Up to 7 Years 3 Months
Progression-free Survival After Subsequent Therapy (PFS2)
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first.
Time frame: Up to 7 Years 3 Months
Disease Control Rate (DCR) as Assessed by BICR
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by BICR using RECIST v1.1 criteria.
Time frame: Up to 7 Years 3 Months
Disease Control Rate (DCR) as Assessed by Investigator
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by the investigator.
Time frame: Up to 7 Years 3 Months
Time to Treatment Failure
Time to treatment failure is defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity, or initiation of new anticancer therapy.
Time frame: Up to 7 Years 3 Months
Curative Resection (R0) Rate
Curative resection (R0) rate is defined as the proportion of participants from the analysis set who underwent curative-intent surgery, where the residual tumor classification was R0.
Time frame: Up to 7 Years 3 Months
Number of Participants with Adverse Events (AEs) by Severity
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. AE severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) v5.0. by using the standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
Time frame: Up to 7 Years 3 Months
Number of Participants with Abnormalities in Laboratory Values
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
Time frame: Up to 7 Years 3 Months
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.
Time frame: From Baseline up to 7 Years 3 Months
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptom.
Time frame: Up to 7 Years 3 Months
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC-QLQ-C29) Score
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms.
Time frame: From Baseline up to 7 Years 3 Months
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms.
Time frame: Up to 7 Years 3 Months
Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score
The EORTC item 168 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "not at all" to 4 "very much." Higher scores indicate severe side effects.
Time frame: Up to 7 Years 3 Months
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Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2028, 49 months after the start.
Of 69 industry-sponsored phase 3 interventional studies under Colorectal Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 54. This study's planned 49 months is above that.
Counting every sponsor, half of 175 studies reached it within 50 months; a quarter within 35 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Amivantamab
Janssen Research & Development, LLC →