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Clinical Trials in the UK / NCT06662786
Recruiting Phase 3

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

NCT06662786 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2024-10-18
Last updated
2026-08-28

Condition(s) studied

Colorectal Neoplasms

Investigational drug(s) / intervention(s)

AmivantamabCetuximab5-fluorouracilLeucovorin calcium/LevoleucovorinOxaliplatinIrinotecan Hydrochloride

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease * Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available) * Must agree to the submission of fresh tumor tissue * Have measurable disease according to RECIST v1.1 * Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (\>) 12 months prior to CRC recurrence/metastases * Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1 Exclusion Criteria: * Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening * Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI * Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor * Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)

Primary outcome measure(s)

Trial sites (239)

FacilityCityRegionStatus
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 the UK

Other trials for the same condition

Official registry record

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 the UK