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 (OrigAMI-3)

June 4, 2026 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Concord, Australia, 2139
        • Recruiting
        • Concord Hospital
      • Heidelberg, Australia, 3084
        • Recruiting
        • Warringal Private Hospital
      • South Woodville, Australia, 5011
        • Recruiting
        • Queen Elizabeth Hospital
      • St Albans, Australia, 3021
        • Recruiting
        • Western Health Sunshine Hospital
  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
      • Edegem, Belgium, 2650
        • Recruiting
        • UZ Antwerpen
      • Ghent, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares
      • Haine Saint Paul La Louviere, Belgium, 7100
        • Recruiting
        • Jolimont
      • Kortrijk, Belgium, 8500
        • Recruiting
        • Az Groeninge
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
  • Brazil
      • Barretos, Brazil, 14780 070
        • Recruiting
        • Fundacao Pio XII
      • Caxias do Sul, Brazil, 95070 560
        • Recruiting
        • Fundacao Universidade de Caxias do Sul
      • Jaú, Brazil, 17210 080
        • Recruiting
        • Fundacao Doutor Amaral Carvalho
      • Porto Alegre, Brazil, 91350 200
        • Recruiting
        • Hospital Nossa Senhora da Conceicao S A
      • Salvador, Brazil, 40050 410
        • Recruiting
        • Hospital Santa Izabel Santa Casa de Misericordia da Bahia
      • São José do Rio Preto, Brazil, 15090 000
        • Recruiting
        • Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
      • São Paulo, Brazil, 01246 000
        • Recruiting
        • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
      • São Paulo, Brazil, 01509 900
        • Recruiting
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo, Brazil, 05651 900
        • Recruiting
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
      • Vitória, Brazil, 29043 260
        • Recruiting
        • Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
  • China
      • Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
      • Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
      • Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital Capital Medical University
      • Changchun, China, 130021
        • Recruiting
        • The First Bethune Hospital of Jilin University
      • Changsha, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
      • Ganzhou, China, 341000
        • Recruiting
        • Ganzhou Cancer Hospital
      • Guangzhou, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital Sun Yat sen University
      • Guangzhou, China, 519041
        • Recruiting
        • Guangdong Provincial People's Hospital
      • Guangzhou, China, 100142
        • Recruiting
        • Sun Yat Sen University Cancer Center
      • Hangzhou, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
      • Hangzhou, China, 310009
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University
      • Harbin, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
      • Huizhou, China, 516001
        • Recruiting
        • Huizhou Central People's Hospital
      • Lanzhou, China, 730050
        • Recruiting
        • Gansu Provincial Cancer Hospital
      • Nanchang, China, 330006
        • Recruiting
        • The First Affiliated Hospital of NanChang University
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
      • Shenyang, China, 110042
        • Recruiting
        • Liaoning Cancer Hospital and Institute
      • Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
      • Wuhan, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
  • France
      • Avignon, France, 84918
        • Recruiting
        • Institut Sainte Catherine
      • Pessac, France, 33604
        • Recruiting
        • Hopital Haut Lévêque
      • Poitiers, France, 86000
        • Recruiting
        • CHU De Poitiers
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charite Universitatsmedizin Berlin Campus Virchow Klinikum
      • Frankfurt am Main, Germany, 60488
        • Recruiting
        • Krankenhaus NorthWest
      • Heidelberg, Germany, 69120
        • Recruiting
        • National Center for Tumor Diseases NCT
      • Mainz, Germany, 55131
        • Recruiting
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
      • Munich, Germany, 81377
        • Recruiting
        • Klinikum der Universitaet Muenchen
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
  • Hungary
      • Eger, Hungary, 3300
        • Completed
        • Markhot Ferenc Oktatokorhaz es Rendelointezet
      • Pécs, Hungary, 7624
        • Completed
        • Pecsi Tudomanyegyetem
      • Szeged, Hungary, 6720
        • Completed
        • Szegedi Tudomanyegyetem
  • India
      • Delhi, India, 110085
        • Recruiting
        • Rajiv Gandhi Cancer Institute and Research Centre
      • Hyderabad, India, 500032
        • Recruiting
        • Asian Institute Of Gastroenterology
      • Kolkata, India, 700053
        • Recruiting
        • B P Poddar Hospital and Medical research Limited
      • Mumbai, India, 400012
        • Recruiting
        • Tata Memorial Hospital
      • New Delhi, India, 110029
        • Recruiting
        • Safdarjung Hospital
      • Pune, India, 411004
        • Recruiting
        • Deenanath Mangeshkar Hospital and Research Centre
      • Varanasi, India, 221005
        • Recruiting
        • Mahamana Pandit Madan Mohan Malviya Cancer Centre
      • Vellore, India, 632004
        • Recruiting
        • Christian medical
  • Israel
      • Beer Yaakov, Israel, 70300
        • Recruiting
        • Yitzhak Shamir Medical Center
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Medical Center
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
      • Ramat Gan, Israel, 52621
        • Recruiting
        • Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
      • Tel Aviv, Israel, 69710
        • Recruiting
        • Assuta MC
  • Italy
      • Candiolo, Italy, 10060
        • Recruiting
        • Fondazione del Piemonte per I Oncologia IRCC Candiolo
      • Milan, Italy, 20133
        • Recruiting
        • Istituto Dei Tumori Di Milano
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto - IRCCS
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
      • Rozzano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
      • Udine, Italy, 33100
        • Recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale ASU FC
  • Japan
      • Chiba, Japan, 260 0801
        • Recruiting
        • Chiba Cancer Center
      • Chūōku, Japan, 104 0045
        • Recruiting
        • National Cancer Center Hospital
      • Kashiwa, Japan, 277 8577
        • Recruiting
        • National Cancer Center Hospital East
      • Nagoya, Japan, 464 8681
        • Recruiting
        • Aichi Cancer Center
      • Osaka, Japan, 541 8567
        • Recruiting
        • Osaka International Cancer Institute
      • Osaka, Japan, 540 0006
        • Recruiting
        • National Hospital Organization Osaka National Hospital
      • Sakai, Japan, 590 0197
        • Recruiting
        • Kindai University Hospital
      • Shizuoka, Japan, 411 8777
        • Recruiting
        • Shizuoka Cancer Center
      • Suita, Japan, 565 0871
        • Recruiting
        • The University of Osaka Hospital
      • Tokyo, Japan, 135 8550
        • Recruiting
        • The Cancer Institute Hospital of JFCR
  • Malaysia
      • George Town, Malaysia, 10450
        • Recruiting
        • Hospital Pulau Pinang
      • Ipoh, Malaysia, 30450
        • Recruiting
        • Hospital Raja Permaisuri Bainun
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre
      • Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Hospital Kuala Lumpur
      • Kuching, Malaysia, 93586
        • Recruiting
        • Hospital Umum Sarawak
      • Putrajaya, Malaysia, 62250
        • Recruiting
        • Institut Kanser Negara Clinical Research Center
  • Mexico
      • Chihuahua City, Mexico, 31217
        • Recruiting
        • Centro Oncologico de Chihuahua
      • Guadalajara, Mexico, 44680
        • Recruiting
        • Actualidad Basada en la Investigación del Cáncer
      • Mexico City, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cancerologia
      • Mexico City, Mexico, 06760
        • Recruiting
        • Centro Oncologico Personalizado Cope S De R L De C V
      • Monterrey, Mexico, 64460
        • Recruiting
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
      • Puebla City, Mexico, 72530
        • Recruiting
        • Oncocenter
      • Querétaro, Mexico, 76000
        • Recruiting
        • Cuidados Oncologicos
      • Querétaro, Mexico, 76230
        • Recruiting
        • Health Pharma Queretaro SA de CV
      • Tijuana, Mexico, 22010
        • Recruiting
        • COI Centro Oncologico Internacional Tijuana
  • Netherlands
      • Amersfoort, Netherlands, 3813 TZ
        • Recruiting
        • Meander Medisch Centrum
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • Antoni van Leeuwenhoek
      • Nijmegen, Netherlands, 6525 GA
        • Recruiting
        • Radboud University Medical Center
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • Erasmus MC
      • Tilburg, Netherlands, 5042 AD
        • Recruiting
        • ETZ TweeSteden
  • Poland
      • Bialystok, Poland, 15 027
        • Recruiting
        • Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
      • Biała Podlaska, Poland, 21 500
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny
      • Brzozów, Poland, 36 200
        • Recruiting
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
      • Gdansk, Poland, 80 214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
      • Gliwice, Poland, 44 100
        • Recruiting
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
      • Lodz, Poland, 93 339
        • Recruiting
        • Instytut Centrum Zdrowia Matki Polki
      • Olsztyn, Poland, 10 228
        • Recruiting
        • Szpital Kliniczny MSWiA z WMCO
      • Opole, Poland, 45 061
        • Recruiting
        • SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
      • Warsaw, Poland, 02 034
        • Recruiting
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials LLC
  • Romania
      • Brasov, Romania, 500091
        • Recruiting
        • Centrul Medical Unirea SRL
      • Bucharest, Romania, 013812
        • Recruiting
        • Spitalul Memorial Baneasa
      • Bucharest, Romania, 014142
        • Recruiting
        • Ponderas Academic Hospital
      • Bucharest, Romania, 077190
        • Recruiting
        • Neolife Medical Center Bucharest
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca
      • Craiova, Romania, 200542
        • Recruiting
        • Clinica de Oncologie Sf Nectarie
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie Iasi
      • Oradea, Romania, 410469
        • Recruiting
        • Pelican Impex SRL
  • South Korea
      • Daegu, South Korea, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea Seoul St Mary s Hospital
  • Spain
      • Badajoz, Spain, 06006
        • Recruiting
        • Hosp. Univ. de Badajoz
      • Barcelona, Spain, 08025
        • Recruiting
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona, Spain, 08028
        • Recruiting
        • Hosp. Univ. Quiron Dexeus
      • Barcelona, Spain, 08003
        • Recruiting
        • Hosp. Del Mar
      • Barcelona, Spain, 08035
        • Recruiting
        • Hosp Univ Vall D Hebron
      • Madrid, Spain, 28034
        • Recruiting
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spain, 28041
        • Recruiting
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28007
        • Recruiting
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Spain, 28002
        • Recruiting
        • Hosp San Francisco de Asis
      • Málaga, Spain, 29010
        • Recruiting
        • Hosp Regional Univ de Malaga
      • Pamplona, Spain, 31008
        • Recruiting
        • Clinica Univ. de Navarra
      • Seville, Spain, 41013
        • Recruiting
        • Hosp. Virgen Del Rocio
      • Valencia, Spain, 46010
        • Recruiting
        • Hosp. Clinico Univ. de Valencia
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Completed
        • Sahlgrenska Universitetssjukhuset
      • Lund, Sweden, 222 42
        • Recruiting
        • Skanes universitetssjukhus
      • Stockholm, Sweden, 118 83
        • Recruiting
        • Sodersjukhuset
      • Stockholm, Sweden, 171 76
        • Recruiting
        • Karolinska Universitetssjukhuset
      • Uppsala, Sweden, SE 751 85
        • Recruiting
        • Uppsala University
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Recruiting
        • Chang Gung Memorial Hospital
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10043
        • Recruiting
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Linkou Chang Gung Memorial Hospital
  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Recruiting
        • Ramathibodi Hospital
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Chiang Mai University
      • Songkhla, Thailand, 90110
        • Recruiting
        • Songklanagarind Hospital
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01060
        • Recruiting
        • Adana City Hospital
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Sehir Hastanesi
      • Ankara, Turkey (Türkiye), 06010
        • Recruiting
        • Gulhane Egitim ve Arastirma Hastanesi
      • Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
      • Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi Universitesi Hastanesi
      • Antalya, Turkey (Türkiye), 07025
        • Recruiting
        • Memorial Antalya Hospital
      • Edirne, Turkey (Türkiye), 22030
        • Recruiting
        • Trakya University Medical Faculty
      • Istanbul, Turkey (Türkiye), 34147
        • Recruiting
        • Bakirkoy Training and Research Hospital
      • Istanbul, Turkey (Türkiye), 34899
        • Recruiting
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
      • Konya, Turkey (Türkiye), 42090
        • Recruiting
        • Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
      • Sakarya, Turkey (Türkiye), 54290
        • Recruiting
        • Sakarya University Training and Research Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B9 5ST
        • Recruiting
        • Birmingham Heartlands Hospital
      • Hull, United Kingdom, HU16 5JQ
        • Recruiting
        • Castle Hill Hospital
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James University Hospital
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew'S Hospital
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital
      • London, United Kingdom, NW1 2BU
        • Recruiting
        • University College Hospital
      • Northwood, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Centre
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Ironwood Cancer and Research Center
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
      • Prescott, Arizona, United States, 86301
        • Completed
        • Arizona Oncology Associates PC NAHOA
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • St. Bernard's Medical Center
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
    • California
      • Bakersfield, California, United States, 93309
        • Recruiting
        • CBCC Global Research
      • Glendale, California, United States, 91204
        • Recruiting
        • Los Angeles Cancer Network
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Cancer and Blood Specialty Clinic
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
      • Torrance, California, United States, 90505
        • Recruiting
        • Torrance Memorial Physicians Network
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Denver Anschultz Medical Campus
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Recruiting
        • Eastern Connecticut Hematology & Oncology Assoc.
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists South
      • Miami Beach, Florida, United States, 33140
        • Completed
        • Mount Sinai Medical Center Campus
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth Cancer Institute
      • St. Petersburg, Florida, United States, 33701-4553
        • Recruiting
        • Florida Cancer Specialists North Region
      • West Palm Beach, Florida, United States, 33401-3406
        • Recruiting
        • Florida Cancer Specialists East
    • Georgia
      • Athens, Georgia, United States, 30607
        • Recruiting
        • University Cancer and Blood Center LLC
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Memorial Hospital
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Piedmont Cancer Institute
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute Emory University
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Recruiting
        • Illinois Cancer Specialists
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Franciscan Health
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • Mission Cancer Blood
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Cancer Center of Kansas
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Mary Bird Perkins Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • MedStar Franklin Square Medical Center
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • Frederick Health Hospital - James M Stockman Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Rogel Cancer Center
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Cancer And Hematology Centers of Western Michigan PC
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Recruiting
        • Hattiesburg Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Long Island
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center NYU Hematology Associates
      • Shirley, New York, United States, 11967
        • Recruiting
        • New York Cancer and Blood Specialists
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Einstein Comprehensive Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospital of Cleveland
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
    • Pennsylvania
      • Penn Wynne, Pennsylvania, United States, 19096
        • Recruiting
        • Alliance Cancer Specialists at Main Line
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15232 1301
        • Recruiting
        • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Tennessee Oncology Chattanooga
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Texas Oncology West Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Parkland Health and Hospital System
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology DFW
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
      • Round Rock, Texas, United States, 77845
        • Recruiting
        • Baylor Scott & White Medical Center
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio
      • Temple, Texas, United States, 76508
        • Recruiting
        • Scott and White Memorial Hospital
      • Tyler, Texas, United States, 75701
        • Recruiting
        • UT Health East Texas HOPE Cancer Center
    • Virginia
      • Arlington, Virginia, United States, 22201
        • Recruiting
        • Virginia Cancer Specialists
      • Richmond, Virginia, United States, 23249
        • Recruiting
        • Richmond VA Medical Center
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Lacey, Washington, United States, 98503
        • Recruiting
        • Providence Regional Cancer System
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

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: 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Amivantamab
Amivantamab will be administered.
Other Names:
  • JNJ-61186372
Drug: 5-fluorouracil
5-fluorouracil will be administered as chemotherapy regimen.
Drug: Leucovorin calcium/Levoleucovorin
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Other Names:
  • Folinic acid
Drug: Irinotecan
Irinotecan will be administered as chemotherapy regimen.
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.
Drug: 5-fluorouracil
5-fluorouracil will be administered as chemotherapy regimen.
Drug: Leucovorin calcium/Levoleucovorin
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Other Names:
  • Folinic acid
Biological: Cetuximab
Cetuximab will be administered.
Other Names:
  • Erbitux
Drug: Irinotecan
Irinotecan will be administered as chemotherapy regimen.
Biological: Bevacizumab
Bevacizumab will be administered.
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to 2 years 1 month
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v)1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date.
Up to 2 years 1 month
Overall Survival (OS)
Time Frame: Up to 4 years 4 months
OS is defined as the time from the date of randomization to the date of participant's death due to any cause.
Up to 4 years 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) as Assessed by BICR
Time Frame: Up to 4 years 4 months
ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria.
Up to 4 years 4 months
Progression Free Survival as Assessed by Investigator
Time Frame: Up to 4 years 4 months
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by investigator.
Up to 4 years 4 months
Duration of Response (DoR) as Assessed by BICR
Time Frame: Up to 4 years 4 months
DoR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR as assessed by BICR.
Up to 4 years 4 months
Duration of Response as Assessed by Investigator
Time Frame: Up to 4 years 4 months
DoR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR as assessed by investigator.
Up to 4 years 4 months
Progression Free Survival After Subsequent Therapy (PFS2)
Time Frame: Up to 4 years 4 months
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent systemic anticancer therapy, based on investigator assessment or death, whichever comes first.
Up to 4 years 4 months
Disease Control Rate (DCR) as Assessed by BICR
Time Frame: Up to 4 years 4 months
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as defined by BICR using RECIST v1.1.
Up to 4 years 4 months
Disease Control Rate as Assessed by Investigator
Time Frame: Up to 4 years 4 months
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as assessed by investigator.
Up to 4 years 4 months
Time to Treatment Failure
Time Frame: Up to 4 years 4 months
Time to treatment failure is defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity, or initiation of new anticancer therapy.
Up to 4 years 4 months
Number of Participants with Adverse Events (AEs) by Severity
Time Frame: Up to 4 years 4 months
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
Up to 4 years 4 months
Number of Participants with Abnormalities in Laboratory Values
Time Frame: Up to 4 years 4 months
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
Up to 4 years 4 months
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
Time Frame: Up to 4 years 4 months
Time to worsening in symptoms and functioning as measured by EORTC QLQ-C30 score will be reported. The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.
Up to 4 years 4 months
Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score
Time Frame: Up to 4 years 4 months
EORTC item 168 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much. Higher scores indicates severe symptoms.
Up to 4 years 4 months
Curative Resection (R0) Rate
Time Frame: Up to 4 years 4 months
Curative resection (R0) rate is defined as the percentage of randomized participants who underwent curative-intent surgery where the residual tumor classification was R0.
Up to 4 years 4 months
ORR as Assessed by Investigator
Time Frame: Up to 4 years 4 months
ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by investigator using RECIST v1.1 criteria.
Up to 4 years 4 months
Time to Response (TTR) as Assessed by BICR
Time Frame: Up to 4 years 4 months
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by BICR.
Up to 4 years 4 months
TTR as Assessed by Investigator
Time Frame: Up to 4 years 4 months
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by investigator.
Up to 4 years 4 months
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Time Frame: From baseline up to 4 years 4 months
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status/quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.
From baseline up to 4 years 4 months
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29) Score
Time Frame: From baseline up to 4 years 4 months
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ-CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms.
From baseline up to 4 years 4 months
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29 Score
Time Frame: Up to 4 years 4 months
Time to worsening in symptoms and functioning as measured by EORTC QLQ-CR29 will be reported. EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ-CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. Change from baseline in the EORTC QLQ-CR29 score will be reported.
Up to 4 years 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

April 13, 2029

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61186372COR3002 (Janssen Research & Development, LLC)
  • 2024-513853-66-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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