A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Amivantamab: Amivantamab will be administered.
Cetuximab: Cetuximab will be administered.
5-fluorouracil: 5-fluorouracil will be administered as chemotherapy regimen.
Leucovorin calcium/Levoleucovorin: Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Oxaliplatin: Oxaliplatin will be administered as chemotherapy regimen.
Irinotecan Hydrochloride: Irinotecan hydrochloride will be administered as chemotherapy regimen.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) — Up to 4 years and 2 months
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.
Trial sites (239)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | Recruiting |
| St. Bernard's Medical Center | Jonesboro | Arkansas | Recruiting |
| Highlands Oncology Group | Springdale | Arkansas | Recruiting |
| CBCC Global Research | Bakersfield | California | Recruiting |
| Los Angeles Cancer Network | Glendale | California | Recruiting |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| UCLA | Santa Monica | California | Recruiting |
| Providence Medical Foundation | Santa Rosa | California | Recruiting |
| Torrance Memorial Physicians Network | Torrance | California | Recruiting |
| Rocky Mountain Cancer Centers | Denver | Colorado | Recruiting |
| Yale University School Of Medicine | New Haven | Connecticut | Recruiting |
| Georgetown Univ Medical Center Lombardi Cancer Center | Washington D.C. | District of Columbia | Recruiting |
| Florida Cancer Specialists South | Fort Myers | Florida | Recruiting |
| AdventHealth Medical Group Oncology and Hematology at Orlando | Orlando | Florida | Recruiting |
| Florida Cancer Specialists North Region | St. Petersburg | Florida | Recruiting |
| Florida Cancer Specialists East | West Palm Beach | Florida | Recruiting |
| Grady Memorial Hospital | Atlanta | Georgia | Recruiting |
| Winship Cancer Institute Emory University | Atlanta | Georgia | Recruiting |
| Illinois Cancer Specialists | Arlington Heights | Illinois | Recruiting |
| Illinois CancerCare | Peoria | Illinois | Recruiting |
| Fort Wayne Medical Oncology & Hematology | Fort Wayne | Indiana | Recruiting |
| University of Iowa Hospital | Iowa City | Iowa | Recruiting |
| Mission Cancer Blood | Waukee | Iowa | Recruiting |
| Cancer Center of Kansas | Wichita | Kansas | Recruiting |
| Ochsner Clinic Foundation | New Orleans | Louisiana | Recruiting |
| MedStar Franklin Square Medical Center | Baltimore | Maryland | Recruiting |
| Frederick Health Hospital - James M Stockman Cancer Institute | Frederick | Maryland | Recruiting |
| VA Ann Arbor Healthcare System | Ann Arbor | Michigan | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | Recruiting |
| Start Midwest | Grand Rapids | Michigan | Recruiting |
| Hattiesburg Clinic | Hattiesburg | Mississippi | Recruiting |
| Washington University School Of Medicine | St Louis | Missouri | Recruiting |
| Nebraska Cancer Specialists Midwest Cancer Center | Omaha | Nebraska | Recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | Recruiting |
| Astera Cancer Care | East Brunswick | New Jersey | Recruiting |
| Rutgers Cancer Institute | New Brunswick | New Jersey | Recruiting |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | Recruiting |
| Perlmutter Cancer Center at NYU Long Island | Mineola | New York | Recruiting |
+ 199 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06662786 on ClinicalTrials.gov ↗ ← All trials in Italy