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
Recruiting · NCT06662786 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
5-fluorouracilAmivantamabCetuximabIrinotecan HydrochlorideLeucovorin calcium/LevoleucovorinOxaliplatin
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
60 locations listed across 31 US states.
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- St. Bernard's Medical Center - Jonesboro, Arkansas, United States
- Highlands Oncology Group - Springdale, Arkansas, United States
- CBCC Global Research - Bakersfield, California, United States
- Los Angeles Cancer Network - Glendale, California, United States
- Cancer and Blood Specialty Clinic - Los Alamitos, California, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- UCLA - Santa Monica, California, United States
- Providence Medical Foundation - Santa Rosa, California, United States
- Torrance Memorial Physicians Network - Torrance, California, United States
- Rocky Mountain Cancer Centers - Denver, Colorado, United States
- Yale University School Of Medicine - New Haven, Connecticut, United States
- Georgetown Univ Medical Center Lombardi Cancer Center - Washington D.C., District of Columbia, United States
- Florida Cancer Specialists South - Fort Myers, Florida, United States
- AdventHealth Medical Group Oncology and Hematology at Orlando - Orlando, Florida, United States
- Florida Cancer Specialists North Region - St. Petersburg, Florida, United States
- Florida Cancer Specialists East - West Palm Beach, Florida, United States
- Grady Memorial Hospital - Atlanta, Georgia, United States
- Winship Cancer Institute Emory University - Atlanta, Georgia, United States
- Illinois Cancer Specialists - Arlington Heights, Illinois, United States
- Illinois CancerCare - Peoria, Illinois, United States
- Fort Wayne Medical Oncology & Hematology - Fort Wayne, Indiana, United States
- University of Iowa Hospital - Iowa City, Iowa, United States
- Mission Cancer Blood - Waukee, Iowa, United States
- Cancer Center of Kansas - Wichita, Kansas, United States
- Ochsner Clinic Foundation - New Orleans, Louisiana, United States
- MedStar Franklin Square Medical Center - Baltimore, Maryland, United States
- Frederick Health Hospital - James M Stockman Cancer Institute - Frederick, Maryland, United States
- VA Ann Arbor Healthcare System - Ann Arbor, Michigan, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Henry Ford Hospital - Detroit, Michigan, United States
- Start Midwest - Grand Rapids, Michigan, United States
- Hattiesburg Clinic - Hattiesburg, Mississippi, United States
- Washington University School Of Medicine - St Louis, Missouri, United States
- Nebraska Cancer Specialists Midwest Cancer Center - Omaha, Nebraska, United States
- Comprehensive Cancer Centers of Nevada - Las Vegas, Nevada, United States
- Astera Cancer Care - East Brunswick, New Jersey, United States
- Rutgers Cancer Institute - New Brunswick, New Jersey, United States
- University of New Mexico Cancer Center - Albuquerque, New Mexico, United States
- Perlmutter Cancer Center at NYU Long Island - Mineola, New York, United States
- Mount Sinai - New York, New York, United States
- Mount Sinai West - New York, New York, United States
- NYU Langone Medical Center NYU Hematology Associates - New York, New York, United States
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center - New York, New York, United States
- New York Cancer and Blood Specialists - Shirley, New York, United States
- Montefiore Einstein Comprehensive Cancer Center - The Bronx, New York, United States
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- Gabrail Cancer Center - Canton, Ohio, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion - Cleveland, Ohio, United States
- Taussig Cancer Insititute Cleveland Clinic - Cleveland, Ohio, United States
- Cleveland Clinic Cancer Center Independence Family Health Center - Independence, Ohio, United States
- Cleveland Clinic Cancer Center Mansfield - Mansfield, Ohio, United States
- Cleveland Clinic Cancer Center Hillcrest Hospital - Mayfield Heights, Ohio, United States
- Cleveland Clinic Cancer Centers Sandusky - Sandusky, Ohio, United States
- Cleveland Clinic Cancer Center Strongsville - Strongsville, Ohio, United States
- Cleveland Clinic Cancer Center South Pointe Hospital - Warrensville Heights, Ohio, United States
- Wooster Milltown Specialty and Surgery Center - Wooster, Ohio, United States
- St Charles Medical Center - Bend, Oregon, United States
- Oregon Health And Science University - Portland, Oregon, United States
Showing 60 of 238 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →