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
Status: Recruiting
Location: See all (226) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
• Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
Locations
United States
Arkansas
St. Bernard's Medical Center
RECRUITING
Jonesboro
Arizona
Banner MD Anderson Cancer Center
RECRUITING
Gilbert
California
CBCC Global Research
RECRUITING
Bakersfield
Los Angeles Cancer Network
RECRUITING
Glendale
Cancer and Blood Specialty Clinic
RECRUITING
Los Alamitos
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
UCLA
RECRUITING
Santa Monica
Providence Medical Foundation
RECRUITING
Santa Rosa
Torrance Memorial Physicians Network
RECRUITING
Torrance
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Denver
Connecticut
Yale University School Of Medicine
RECRUITING
New Haven
Washington, D.c.
Georgetown Univ Medical Center Lombardi Cancer Center
SUSPENDED
Washington D.c.
Florida
Florida Cancer Specialists South
RECRUITING
Fort Myers
AdventHealth Medical Group Oncology and Hematology at Orlando
RECRUITING
Orlando
Florida Cancer Specialists North Region
RECRUITING
St. Petersburg
Florida Cancer Specialists East
RECRUITING
West Palm Beach
Georgia
Grady Memorial Hospital
RECRUITING
Atlanta
Winship Cancer Institute Emory University
RECRUITING
Atlanta
Indiana
Fort Wayne Medical Oncology & Hematology
SUSPENDED
Fort Wayne
Louisiana
Ochsner Clinic Foundation
RECRUITING
New Orleans
Maryland
MedStar Franklin Square Medical Center
SUSPENDED
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
VA Ann Arbor Healthcare System
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Start Midwest
RECRUITING
Grand Rapids
Missouri
Washington University School Of Medicine
RECRUITING
St Louis
Mississippi
Hattiesburg Clinic
RECRUITING
Hattiesburg
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Nebraska
Nebraska Cancer Specialists Midwest Cancer Center
RECRUITING
Omaha
New Jersey
Astera Cancer Care
RECRUITING
East Brunswick
Rutgers Cancer Institute
RECRUITING
New Brunswick
New Mexico
University of New Mexico Cancer Center
RECRUITING
Albuquerque
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
New York
Perlmutter Cancer Center at NYU Long Island
RECRUITING
Mineola
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
RECRUITING
New York
Mount Sinai
RECRUITING
New York
Mount Sinai West
RECRUITING
New York
NYU Langone Medical Center NYU Hematology Associates
RECRUITING
New York
New York Cancer and Blood Specialists
RECRUITING
Shirley
Montefiore Einstein Comprehensive Cancer Center
RECRUITING
The Bronx
Ohio
Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
RECRUITING
Cleveland
Taussig Cancer Insititute Cleveland Clinic
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Cleveland Clinic Cancer Center Independence Family Health Center
RECRUITING
Independence
Cleveland Clinic Cancer Center Mansfield
RECRUITING
Mansfield
Cleveland Clinic Cancer Center Hillcrest Hospital
RECRUITING
Mayfield Heights
Cleveland Clinic Cancer Centers Sandusky
RECRUITING
Sandusky
Cleveland Clinic Cancer Center Strongsville
RECRUITING
Strongsville
Cleveland Clinic Cancer Center South Pointe Hospital
RECRUITING
Warrensville Heights
Wooster Milltown Specialty and Surgery Center
RECRUITING
Wooster
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Thomas Jefferson University
RECRUITING
Philadelphia
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology West Texas
RECRUITING
Abilene
Texas Oncology DFW
RECRUITING
Dallas
UT Southwestern
RECRUITING
Dallas
MD Anderson Cancer Center
RECRUITING
Houston
Texas Oncology - San Antonio
RECRUITING
San Antonio
Baylor Scott and White Health
RECRUITING
Temple
Virginia
Virginia Cancer Specialists
RECRUITING
Arlington
Inova Schar Cancer Institute Dept of Fairfax Hospital
RECRUITING
Fairfax
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Washington
Swedish Cancer Institute
RECRUITING
Edmonds
Swedish Cancer Institute
RECRUITING
Issaquah
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Swedish Cancer Institute
RECRUITING
Seattle
Wisconsin
William S. Middleton Memorial VA
RECRUITING
Madison
Other Locations
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
AZ Maria Middelares
RECRUITING
Ghent
Hopital de Jolimont
RECRUITING
Haine Saint Paul La Louviere
Az Groeninge
RECRUITING
Kortrijk
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
RECRUITING
Liège
Brazil
Fundacao Pio XII
RECRUITING
Barretos
Fundacao Universidade de Caxias do Sul
RECRUITING
Caxias Do Sul
Fundacao Doutor Amaral Carvalho
RECRUITING
Jaú
Hospital Nossa Senhora da Conceicao S A
RECRUITING
Porto Alegre
Hospital Santa Izabel Santa Casa de Misericordia da Bahia
RECRUITING
Salvador
Clinica de Hematologia e Oncologia Viver Ltda
RECRUITING
Santa Maria
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
RECRUITING
São José Do Rio Preto
Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
São Paulo
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
RECRUITING
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING
São Paulo
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
RECRUITING
Vitória
Canada
Arthur J E Child Comprehensive Cancer Centre
RECRUITING
Calgary
Centre de Recherche du CHUM
RECRUITING
Montreal
Ottawa Hospital
RECRUITING
Ottawa
Princess Margaret Cancer Centre
RECRUITING
Toronto
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing Friendship Hospital Capital Medical University
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer hospital
RECRUITING
Changsha
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Sun Yat Sen University Cancer Center
RECRUITING
Guangzhou
The Sixth Affiliated Hospital Sun Yat sen University
RECRUITING
Guangzhou
The First Affiliated Hospital Zhejiang University College of Medicine
RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University College of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Harbin medical university cancer hospital
RECRUITING
Harbin
Huizhou Central People's Hospital
RECRUITING
Huizhou
The First Affiliated Hospital of NanChang University
RECRUITING
Nanchang
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
West China Hospital of Sichuan University
RECRUITING
Sichuan
First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Hubei Cancer Hospital
RECRUITING
Wuhan
France
Institut Sainte Catherine
RECRUITING
Avignon
Hopital Claude Huriez
RECRUITING
Lille
Hopital Prive Jean Mermoz
RECRUITING
Lyon
Institut du Cancer de Montpellier
RECRUITING
Montpellier
CHU Nantes
RECRUITING
Nantes
Hopital Saint Antoine
RECRUITING
Paris
Hopital Haut Leveque
RECRUITING
Pessac
CHU De Poitiers
RECRUITING
Poitiers
Gustave Roussy
RECRUITING
Villejuif
Germany
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
RECRUITING
Berlin
Universitaetsklinikum Carl Gustav Carus TU Dresden
RECRUITING
Dresden
Essen University Hospital
RECRUITING
Essen
Krankenhaus NorthWest
RECRUITING
Frankfurt Am Main
Praxis fur interdisziplinare Onkologie & Hamatologie GbR
RECRUITING
Freiburg Im Breisgau
Asklepios Klinik Altona
RECRUITING
Hamburg
National Center for Tumor Diseases NCT
RECRUITING
Heidelberg
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
RECRUITING
Mainz
Klinikum der Universitaet Muenchen
RECRUITING
Munich
Universitatsklinikum Ulm
RECRUITING
Ulm
Hungary
Semmelweis Egyetem
RECRUITING
Budapest
Markhot Ferenc Oktatokorhaz es Rendelointezet
RECRUITING
Eger
Pecsi Tudomanyegyetem
RECRUITING
Pécs
Szegedi Tudomanyegyetem
RECRUITING
Szeged
India
Rajiv Gandhi Cancer Institute and Research Centre
RECRUITING
Delhi
B P Poddar Hospital and Medical research Limited
RECRUITING
Kolkata
Tata Memorial Hospital
RECRUITING
Mumbai
Deenanath Mangeshkar Hospital and Research Centre
RECRUITING
Pune
Mahamana Pandit Madan Mohan Malviya Cancer Centre
RECRUITING
Varanasi
Israel
Yitzhak Shamir Medical Center
RECRUITING
Beer Yaakov
Rambam Medical Center
RECRUITING
Haifa
Hadassah University Hospita Ein Kerem
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Assuta MC
RECRUITING
Tel Aviv
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
RECRUITING
Meldola
Istituto Dei Tumori Di Milano
RECRUITING
Milan
Istituto Oncologico Veneto - IRCCS
RECRUITING
Padua
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Istituto Clinico Humanitas
RECRUITING
Rozzano
Japan
Chiba Cancer Center
RECRUITING
Chiba
National Cancer Center Hospital
RECRUITING
Chūōku
National Cancer Center Hospital East
RECRUITING
Kashiwa
Aichi Cancer Center
RECRUITING
Nagoya
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Osaka International Cancer Institute
RECRUITING
Osaka
Shizuoka Cancer Center
RECRUITING
Shizuoka
The University of Osaka Hospital
RECRUITING
Suita
The Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
Malaysia
Hospital Canselor Tuanku Muhriz UKM
RECRUITING
Cheras
Hospital Pulau Pinang
RECRUITING
George Town
Hospital Raja Permaisuri Bainun
RECRUITING
Ipoh
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Umum Sarawak
RECRUITING
Kuching
National Cancer Institute
RECRUITING
Putrajaya
Netherlands
Meander Medisch Centrum
RECRUITING
Amersfoort
Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Radboud University Medical Center
RECRUITING
Nijmegen
Erasmus MC
RECRUITING
Rotterdam
Elisabeth-TweeSteden Ziekenhuis
RECRUITING
Tilburg
UMC Utrecht
RECRUITING
Utrecht
Poland
Wojewodzki Szpital Specjalistyczny
RECRUITING
Biała Podlaska
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
RECRUITING
Bialystok
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
RECRUITING
Brzozów
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
RECRUITING
Gliwice
Instytut Centrum Zdrowia Matki Polki
RECRUITING
Lodz
SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie
RECRUITING
Olsztyn
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
RECRUITING
Opole
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
RECRUITING
Warsaw
Puerto Rico
Pan American Center for Oncology Trials LLC
RECRUITING
Barrio Monacillos
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
Seoul
Spain
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Madrid
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Univ. Ramon Y Cajal
RECRUITING
Madrid
Clinica Univ. de Navarra
RECRUITING
Pamplona
Hosp. Virgen Del Rocio
RECRUITING
Seville
Hosp. Clinico Univ. de Valencia
RECRUITING
Valencia
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Skanes universitetssjukhus
RECRUITING
Lund
Karolinska Universitetssjukhuset
RECRUITING
Stockholm
Sodersjukhuset
RECRUITING
Stockholm
Uppsala University
RECRUITING
Uppsala
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung Ho Memorial Hospital
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Turkey
Adana City Hospital
RECRUITING
Adana
Ankara Bilkent Sehir Hastanesi
RECRUITING
Ankara
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING
Ankara
Gazi University Hospital
RECRUITING
Ankara
Gulhane Egitim ve Arastirma Hastanesi
RECRUITING
Ankara
Bakirkoy Training and Research Hospital
RECRUITING
Istanbul
Marmara University Pendik Training Hospital
RECRUITING
Istanbul
Necmettin Erbakan University Meram Medical Faculty
RECRUITING
Konya
Sakarya University Training and Research Hospital
RECRUITING
Sakarya
United Kingdom
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Addenbrooke's Hospital
RECRUITING
Cambridge
Western General Hospital
RECRUITING
Edinburgh
Castle Hill Hospital
RECRUITING
Hull
St James University Hospital
RECRUITING
Leeds
St Bartholomew's Hospital
RECRUITING
London
University College Hospital
RECRUITING
London
Mount Vernon Cancer Centre
RECRUITING
Northwood
Royal Marsden Hospital (Sutton)
RECRUITING
Sutton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2032-12-15
Participants
Target number of participants: 1000
Treatments
Experimental: Arm A: Amivantamab in Combination With Chemotherapy
Participants will receive amivantamab in combination with chemotherapy (mFOLFOX6 \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin\] or FOLFIRI \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride\]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
Active_comparator: Arm B: Cetuximab in Combination With Chemotherapy
Participants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC