A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy
Status: Recruiting
Location: See all (217) locations...
Intervention Type: Biological, Drug
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) 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
• Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
• Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
• Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
• Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
• Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy
Locations
United States
Arkansas
St. Bernard's Medical Center
RECRUITING
Jonesboro
Arizona
Ironwood Cancer and Research Center
RECRUITING
Chandler
Banner MD Anderson Cancer Center
RECRUITING
Gilbert
Arizona Oncology Associates PC NAHOA
RECRUITING
Prescott
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
University of Colorado Denver Anschultz Medical Campus
RECRUITING
Aurora
Rocky Mountain Cancer Centers
RECRUITING
Denver
Connecticut
Eastern Connecticut Hematology & Oncology Assoc.
RECRUITING
Norwich
Florida
Florida Cancer Specialists South
RECRUITING
Fort Myers
Mount Sinai Medical Center Campus
RECRUITING
Miami Beach
AdventHealth Cancer Institute
RECRUITING
Orlando
Florida Cancer Specialists North Region
RECRUITING
St. Petersburg
Florida Cancer Specialists East
RECRUITING
West Palm Beach
Georgia
University Cancer And Blood Center LLC
RECRUITING
Athens
Grady Memorial Hospital
RECRUITING
Atlanta
Piedmont Cancer Institute
RECRUITING
Atlanta
Winship Cancer Institute Emory University
RECRUITING
Atlanta
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Maryland
MedStar Franklin Square Medical Center
SUSPENDED
Baltimore
Michigan
University of Michigan Rogel Cancer Center
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Cancer And Hematology Centers of Western Michigan PC
RECRUITING
Grand Rapids
Missouri
Washington University School Of Medicine
RECRUITING
St Louis
Mississippi
Hattiesburg Clinic
RECRUITING
Hattiesburg
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
New Jersey
Astera Cancer Care
RECRUITING
East Brunswick
New York
Perlmutter Cancer Center at NYU Long Island
RECRUITING
Mineola
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
University Hospital of Cleveland
RECRUITING
Cleveland
Pennsylvania
Alliance Cancer Specialists at Main Line
RECRUITING
Penn Wynne
Fox Chase Cancer Center
RECRUITING
Philadelphia
Thomas Jefferson University
RECRUITING
Philadelphia
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
Tennessee Oncology
RECRUITING
Chattanooga
SCRI Oncology Partners
RECRUITING
Nashville
Tennessee Oncology
RECRUITING
Nashville
Texas
Texas Oncology West Texas
RECRUITING
Abilene
Texas Oncology DFW
RECRUITING
Dallas
MD Anderson Cancer Center
RECRUITING
Houston
Texas Oncology - San Antonio
RECRUITING
San Antonio
Scott And White Memorial Hospital
RECRUITING
Temple
UT Health East Texas HOPE Cancer Center
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists
RECRUITING
Arlington
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Washington
Providence Regional Cancer System
RECRUITING
Lacey
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Other Locations
Australia
Concord Hospital
RECRUITING
Concord
Warringal Private Hospital
RECRUITING
Heidelberg
Queen Elizabeth Hospital
RECRUITING
South Woodville
Western Health Sunshine Hospital
RECRUITING
St Albans
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
UZ Antwerpen
RECRUITING
Edegem
AZ Maria Middelares
RECRUITING
Ghent
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
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
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
RECRUITING
Vitória
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing Friendship Hospital Capital Medical University
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer hospital
RECRUITING
Changsha
West China Hospital of Sichuan University
RECRUITING
Chengdu
Ganzhou Cancer Hospital
RECRUITING
Ganzhou
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 Second Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Harbin medical university cancer hospital
RECRUITING
Harbin
Huizhou Central People's Hospital
RECRUITING
Huizhou
Gansu Provincial Cancer Hospital
RECRUITING
Lanzhou
The First Affiliated Hospital of NanChang University
RECRUITING
Nanchang
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Hubei Cancer Hospital
RECRUITING
Wuhan
France
Institut Sainte Catherine
RECRUITING
Avignon
Hopital Haut Leveque
RECRUITING
Pessac
CHU De Poitiers
RECRUITING
Poitiers
Germany
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
RECRUITING
Berlin
Krankenhaus NorthWest
RECRUITING
Frankfurt Am Main
National Center for Tumor Diseases NCT
RECRUITING
Heidelberg
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
RECRUITING
Mainz
Klinikum der Universitaet Muenchen
RECRUITING
Munich
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Prince Of Wales Hospital
RECRUITING
Shatin
Hungary
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
Asian Institute Of Gastroenterology
RECRUITING
Hyderabad
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
Christian medical
RECRUITING
Vellore
Israel
Yitzhak Shamir Medical Center
RECRUITING
Beer Yaakov
Rambam Medical Center
RECRUITING
Haifa
Hadassah Medical Center
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 Dei Tumori Di Milano
RECRUITING
Milan
Istituto Oncologico Veneto - IRCCS
RECRUITING
Padua
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Istituto Clinico Humanitas
RECRUITING
Rozzano
Azienda Sanitaria Universitaria Friuli Centrale ASU FC
RECRUITING
Udine
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
Kindai University Hospital
RECRUITING
Osaka Sayama Shi
Shizuoka Cancer Center
RECRUITING
Shizuoka
The University of Osaka Hospital
RECRUITING
Suita
The Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
Malaysia
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
Institut Kanser Negara Clinical Research Center
RECRUITING
Putrajaya
Mexico
Centro Oncologico de Chihuahua
RECRUITING
Chihuahua City
Actualidad Basada En La Investigacion Del Cancer
RECRUITING
Guadalajara
Centro Oncologico Personalizado Cope S De R L De C V
RECRUITING
Mexico City
Hospital Universitario Dr Jose Eleuterio Gonzalez
RECRUITING
Monterrey
Oncocenter
RECRUITING
Puebla City
Cuidados Oncologicos
RECRUITING
Querétaro
Health Pharma Queretaro SA de CV
RECRUITING
Querétaro
COI Centro Oncologico Internacional Tijuana
RECRUITING
Tijuana
Netherlands
Meander Medisch Centrum
RECRUITING
Amersfoort
Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Radboud University Medical Center
RECRUITING
Nijmegen
Erasmus MC
RECRUITING
Rotterdam
ETZ TweeSteden
RECRUITING
Tilburg
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
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Puerto Rico
Pan American Center for Oncology Trials LLC
RECRUITING
San Juan
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Asan Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
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 Mary s Hospital
RECRUITING
Seoul
Romania
Centrul Medical Unirea SRL
RECRUITING
Brasov
Ponderas Academic Hospital
RECRUITING
Bucharest
Spitalul Memorial Baneasa
RECRUITING
Bucharest
Clinica de Oncologie Sf Nectarie
RECRUITING
Craiova
Pelican Impex SRL
RECRUITING
Oradea
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 Universitetssjukhuset
RECRUITING
Gothenburg
Skanes universitetssjukhus
RECRUITING
Lund
Karolinska Universitetssjukhuset
RECRUITING
Stockholm
Sodersjukhuset
RECRUITING
Stockholm
Uppsala University
RECRUITING
Uppsala
Taiwan
Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Thailand
Ramathibodi Hospital
RECRUITING
Bangkok
Siriraj Hospital
RECRUITING
Bangkok
Chiang Mai University
RECRUITING
Chiang Mai
Songklanagarind hospital
RECRUITING
Songkhla
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
Castle Hill Hospital
RECRUITING
Hull
St James University Hospital
RECRUITING
Leeds
Royal Marsden Hospital
RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
University College Hospital
RECRUITING
London
Mount Vernon Cancer Centre
RECRUITING
Northwood
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2029-04-13
Participants
Target number of participants: 700
Treatments
Experimental: Arm A: Amivantamab + FOLFIRI
Participants will receive amivantamab along with FOLFIRI (consisting of 5-fluorouracil, leucovorin calcium \[folinic acid\] or levoleucovorin, and irinotecan) as a chemotherapy regimen 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 or Bevacizumab + FOLFIRI
Participants will receive either cetuximab or bevacizumab along with FOLFIRI as a chemotherapy regimen 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