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
Condition(s) studied
Investigational drug(s) / intervention(s)
Amivantamab: Amivantamab will be administered.
Cetuximab: Cetuximab will be administered.
Bevacizumab: Bevacizumab 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.
Irinotecan: Irinotecan 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) 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 (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) — 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) — 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.
Trial sites (251)
| Facility | City | Region | Status |
|---|---|---|---|
| Ironwood Cancer and Research Center | Chandler | Arizona | Recruiting |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | Recruiting |
| Arizona Oncology Associates PC NAHOA | Prescott | Arizona | Completed |
| 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 |
| University of Colorado Denver Anschultz Medical Campus | Aurora | Colorado | Recruiting |
| Rocky Mountain Cancer Centers | Denver | Colorado | Recruiting |
| Eastern Connecticut Hematology & Oncology Assoc. | Norwich | Connecticut | Completed |
| Florida Cancer Specialists South | Fort Myers | Florida | Recruiting |
| Mount Sinai Medical Center Campus | Miami Beach | Florida | Completed |
| AdventHealth Cancer Institute | Orlando | Florida | Recruiting |
| Florida Cancer Specialists North Region | St. Petersburg | Florida | Recruiting |
| Florida Cancer Specialists East | West Palm Beach | Florida | Recruiting |
| University Cancer And Blood Center LLC | Athens | Georgia | Recruiting |
| Grady Memorial Hospital | Atlanta | Georgia | Recruiting |
| Piedmont Cancer Institute | Atlanta | Georgia | Recruiting |
| Winship Cancer Institute Emory University | Atlanta | Georgia | Recruiting |
| Illinois Cancer Specialists | Arlington Heights | Illinois | Recruiting |
| Illinois CancerCare | Peoria | Illinois | Recruiting |
| Franciscan Health | Indianapolis | Indiana | Recruiting |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | Recruiting |
| Mission Cancer Blood | Waukee | Iowa | Recruiting |
| Cancer Center of Kansas | Wichita | Kansas | Recruiting |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | Recruiting |
| MedStar Franklin Square Medical Center | Baltimore | Maryland | Recruiting |
| Frederick Health Hospital - James M Stockman Cancer Institute | Frederick | Maryland | Recruiting |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | Recruiting |
| Cancer And Hematology Centers of Western Michigan PC | Grand Rapids | Michigan | Recruiting |
| Hattiesburg Clinic | Hattiesburg | Mississippi | Recruiting |
| Washington University School Of Medicine | St Louis | Missouri | Recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | Recruiting |
| Astera Cancer Care | East Brunswick | New Jersey | Recruiting |
+ 211 more sites — see the full list on the official registry below.
On this site
📄 Avastin (bevacizumab) drug profile →More Janssen Research & Development, LLC trials in Poland
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 NCT06750094 on ClinicalTrials.gov ↗ ← All trials in Poland