A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
NCT ID: NCT06750094
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
700 participants
INTERVENTIONAL
2024-12-12
2029-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Amivantamab
Amivantamab 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.
Irinotecan
Irinotecan will be administered as chemotherapy regimen.
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.
Cetuximab
Cetuximab will be administered.
Bevacizumab
Bevacizumab 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.
Irinotecan
Irinotecan will be administered as chemotherapy regimen.
Interventions
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Amivantamab
Amivantamab will be administered.
Cetuximab
Cetuximab will be administered.
Bevacizumab
Bevacizumab 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.
Irinotecan
Irinotecan will be administered as chemotherapy regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or 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 who has not received immunotherapy treatments
* Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
* Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Ironwood Cancer and Research Center
Chandler, Arizona, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Arizona Oncology Associates PC NAHOA
Prescott, Arizona, United States
St. Bernard's Medical Center
Jonesboro, 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
University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Eastern Connecticut Hematology & Oncology Assoc.
Norwich, Connecticut, United States
Florida Cancer Specialists South
Fort Myers, Florida, United States
Mount Sinai Medical Center Campus
Miami Beach, Florida, United States
AdventHealth Cancer Institute
Orlando, Florida, United States
Florida Cancer Specialists North Region
St. Petersburg, Florida, United States
Florida Cancer Specialists East
West Palm Beach, Florida, United States
University Cancer And Blood Center LLC
Athens, Georgia, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Piedmont Cancer Institute
Atlanta, Georgia, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, United States
Illinois CancerCare
Peoria, Illinois, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
MedStar Franklin Square Medical Center
Baltimore, Maryland, United States
University of Michigan Rogel Cancer Center
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
Omaha, Nebraska, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Perlmutter Cancer Center at NYU Long Island
Mineola, New York, United States
NYU Langone Medical Center NYU Hematology Associates
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 Hospital of Cleveland
Cleveland, Ohio, United States
Oregon Health And Science University
Portland, Oregon, United States
Alliance Cancer Specialists at Main Line
Penn Wynne, Pennsylvania, 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
Tennessee Oncology
Chattanooga, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology West Texas
Abilene, Texas, United States
Texas Oncology DFW
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Scott And White Memorial Hospital
Temple, Texas, United States
UT Health East Texas HOPE Cancer Center
Tyler, Texas, United States
Virginia Cancer Specialists
Arlington, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Providence Regional Cancer System
Lacey, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
Concord Hospital
Concord, , Australia
Warringal Private Hospital
Heidelberg, , Australia
Queen Elizabeth Hospital
South Woodville, , Australia
Western Health Sunshine Hospital
St Albans, , Australia
Institut Jules Bordet
Anderlecht, , Belgium
UZ Antwerpen
Edegem, , Belgium
AZ Maria Middelares
Ghent, , Belgium
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
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
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
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, , Brazil
Peking University First Hospital
Beijing, , China
Beijing Friendship Hospital Capital Medical University
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
The First Bethune Hospital of Jilin University
Changchun, , China
Hunan Cancer hospital
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
Ganzhou Cancer Hospital
Ganzhou, , China
Sun Yat Sen University Cancer Center
Guangzhou, , China
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin medical university cancer hospital
Harbin, , China
Huizhou Central People's Hospital
Huizhou, , China
Gansu Provincial Cancer Hospital
Lanzhou, , China
The First Affiliated Hospital of NanChang University
Nanchang, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Liaoning Cancer Hospital and Institute
Shenyang, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Hubei Cancer Hospital
Wuhan, , China
Institut Sainte Catherine
Avignon, , France
Hopital Haut Leveque
Pessac, , France
CHU De Poitiers
Poitiers, , France
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
Berlin, , Germany
Krankenhaus NorthWest
Frankfurt am Main, , Germany
National Center for Tumor Diseases NCT
Heidelberg, , Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, , Germany
Klinikum der Universitaet Muenchen
Munich, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Prince Of Wales Hospital
Shatin, , Hong Kong
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, , Hungary
Pecsi Tudomanyegyetem
Pécs, , Hungary
Szegedi Tudomanyegyetem
Szeged, , Hungary
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, , India
Asian Institute Of Gastroenterology
Hyderabad, , India
B P Poddar Hospital and Medical research Limited
Kolkata, , India
Tata Memorial Hospital
Mumbai, , India
Safdarjung Hospital
New Delhi, , India
Deenanath Mangeshkar Hospital and Research Centre
Pune, , India
Mahamana Pandit Madan Mohan Malviya Cancer Centre
Varanasi, , India
Christian medical
Vellore, , India
Yitzhak Shamir Medical Center
Beer Yaakov, , Israel
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Assuta MC
Tel Aviv, , Israel
Istituto Dei Tumori Di Milano
Milan, , Italy
Istituto Oncologico Veneto - IRCCS
Padua, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Azienda Sanitaria Universitaria Friuli Centrale ASU FC
Udine, , Italy
Chiba Cancer Center
Chiba, , Japan
National Cancer Center Hospital
Chūōku, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
Aichi Cancer Center
Nagoya, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Kindai University Hospital
Sakai, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
The University of Osaka Hospital
Suita, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Hospital Pulau Pinang
George Town, , Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Umum Sarawak
Kuching, , Malaysia
Institut Kanser Negara Clinical Research Center
Putrajaya, , Malaysia
Centro Oncologico de Chihuahua
Chihuahua City, , Mexico
Actualidad Basada En La Investigacion Del Cancer
Guadalajara, , Mexico
Centro Oncologico Personalizado Cope S De R L De C V
Mexico City, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, , Mexico
Oncocenter
Puebla City, , Mexico
Cuidados Oncologicos
Querétaro, , Mexico
Health Pharma Queretaro SA de CV
Querétaro, , Mexico
COI Centro Oncologico Internacional Tijuana
Tijuana, , Mexico
Meander Medisch Centrum
Amersfoort, , Netherlands
Antoni van Leeuwenhoek
Amsterdam, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
ETZ TweeSteden
Tilburg, , Netherlands
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
Bialystok, , Poland
Wojewodzki Szpital Specjalistyczny
Biała Podlaska, , Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
Gliwice, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, , Poland
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
Opole, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, , Poland
Pan American Center for Oncology Trials LLC
San Juan, , Puerto Rico
Centrul Medical Unirea SRL
Brasov, , Romania
Spitalul Memorial Baneasa
Bucharest, , Romania
Ponderas Academic Hospital
Bucharest, , Romania
Neolife Medical Center Bucharest
Bucharest, , Romania
Clinica de Oncologie Sf Nectarie
Craiova, , Romania
Pelican Impex SRL
Oradea, , Romania
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, , South Korea
Hosp. de La Santa Creu I Sant Pau
Barcelona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp. Virgen Del Rocio
Seville, , Spain
Hosp. Clinico Univ. de Valencia
Valencia, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Skanes universitetssjukhus
Lund, , Sweden
Sodersjukhuset
Stockholm, , Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
Uppsala University
Uppsala, , Sweden
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Ramathibodi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Chiang Mai University
Chiang Mai, , Thailand
Songklanagarind hospital
Songkhla, , Thailand
Adana City Hospital
Adana, , Turkey (Türkiye)
Gulhane Egitim ve Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, , Turkey (Türkiye)
Gazi University Hospital
Ankara, , Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Bakirkoy Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Marmara University Pendik Training Hospital
Istanbul, , Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty
Konya, , Turkey (Türkiye)
Sakarya University Training and Research Hospital
Sakarya, , Turkey (Türkiye)
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Castle Hill Hospital
Hull, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Mount Vernon Cancer Centre
Northwood, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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61186372COR3002
Identifier Type: OTHER
Identifier Source: secondary_id
2024-513853-66-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
61186372COR3002
Identifier Type: -
Identifier Source: org_study_id