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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
Sponsor: Janssen Research & Development, LLC
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.
Official title: A Randomized, Open-label Phase 3 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2024-10-18
Completion Date
2032-01-20
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (239)
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
Cancer And Hematology Centers of Western Michigan PC
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 Buffalo Kaleida Health Cancer Care
Williamsville, 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
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology West Texas
Abilene, Texas, United States
Texas Oncology DFW
Dallas, Texas, United States
UT Southwestern
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Baylor Scott and White Health 1
Round Rock, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Baylor Scott and White Health
Temple, Texas, United States
Virginia Cancer Specialists
Arlington, Virginia, United States
Inova Schar Cancer Institute Dept of Fairfax Hospital
Fairfax, Virginia, United States
Richmond VA Medical Center
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Swedish Cancer Institute Edmonds
Edmonds, Washington, United States
Swedish Cancer Institute Issaquah
Issaquah, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
William S. Middleton Memorial VA
Madison, Wisconsin, United States
Institut Jules Bordet
Anderlecht, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
AZ Maria Middelares
Ghent, Belgium
Hopital de Jolimont
Haine Saint Paul La Louviere, Belgium
Az Groeninge
Kortrijk, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, Belgium
Fundacao Pio XII
Barretos, Brazil
Fundacao Universidade de Caxias do Sul
Caxias do Sul, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, Brazil
Hospital Nossa Senhora da Conceicao S A
Porto Alegre, Brazil
Hospital Santa Izabel Santa Casa de Misericordia da Bahia
Salvador, Brazil
Clinica de Hematologia e Oncologia Viver Ltda
Santa Maria, Brazil
Funfarme Sjrp
São José do Rio Preto, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada