A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (OrigAMI-2)

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

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

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

  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
      • Edegem, Belgium, 2650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
      • Ghent, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares
      • Haine Saint Paul La Louviere, Belgium, 7100
        • Recruiting
        • Hopital de 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
      • Santa Maria, Brazil, 97015 450
        • Recruiting
        • Clinica de Hematologia e Oncologia Viver Ltda
      • 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
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J E Child Comprehensive Cancer Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital
      • Toronto, Ontario, Canada, M5G1X6
        • Recruiting
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre de recherche du CHUM
  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
      • 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
      • Guangzhou, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital Sun Yat sen University
      • Guangzhou, China, 519041
        • Recruiting
        • Guangdong Provincial People's Hospital
      • Guangzhou, China, 510062
        • Recruiting
        • Sun Yat Sen University Cancer Center
      • Hangzhou, China, 310009
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University College of Medicine
      • Hangzhou, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
      • Hangzhou, China, 310003
        • Recruiting
        • The First Affiliated Hospital Zhejiang University College of Medicine
      • Harbin, China, 150081
        • Recruiting
        • Harbin medical university cancer hospital
      • Huizhou, China, 516001
        • Recruiting
        • Huizhou Central People's 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
      • Shenzhen, China, 518036
        • Recruiting
        • Peking University Shenzhen Hospital
      • Sichuan, China, 610044
        • Recruiting
        • West China Hospital of Sichuan University
      • Taiyuan, China, 030001
        • Recruiting
        • First Hospital of Shanxi Medical University
      • 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
      • Lille, France, 59000
        • Recruiting
        • Hopital Claude Huriez
      • Lyon, France, 69008
        • Recruiting
        • Hôpital Privé Jean Mermoz
      • Montpellier, France, 34298
        • Recruiting
        • Institut du Cancer de Montpellier
      • Nantes, France, 44000
        • Recruiting
        • Chu Nantes
      • Paris, France, 75571
        • Recruiting
        • Hôpital Saint Antoine
      • Pessac, France, 33604
        • Recruiting
        • Hopital Haut Leveque
      • Poitiers, France, 86000
        • Recruiting
        • CHU De Poitiers
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charite Universitatsmedizin Berlin Campus Virchow Klinikum
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Essen, Germany, 45147
        • Recruiting
        • Essen University Hospital
      • Frankfurt am Main, Germany, 60488
        • Recruiting
        • Krankenhaus NorthWest
      • Freiburg im Breisgau, Germany, 79110
        • Recruiting
        • Praxis fur interdisziplinare Onkologie & Hamatologie GbR
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Klinik Altona
      • 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
      • Ulm, Germany, 89081
        • Recruiting
        • Universitatsklinikum Ulm
  • Hungary
      • Budapest, Hungary, 1082
        • Recruiting
        • Semmelweis Egyetem
      • Eger, Hungary, 3300
        • Recruiting
        • Markhot Ferenc Oktatokorhaz es Rendelointezet
      • Pécs, Hungary, 7624
        • Completed
        • Pécsi Tudományegyetem
      • Szeged, Hungary, 6720
        • Recruiting
        • Szegedi Tudomanyegyetem
  • India
      • Delhi, India, 110085
        • Recruiting
        • Rajiv Gandhi Cancer Institute and Research Centre
      • Kolkata, India, 700053
        • Recruiting
        • B P Poddar Hospital and Medical research Limited
      • Mumbai, India, 400012
        • Recruiting
        • Tata Memorial Hospital
      • Pune, India, 411004
        • Recruiting
        • Deenanath Mangeshkar Hospital and Research Centre
      • Varanasi, India, 221005
        • Recruiting
        • Mahamana Pandit Madan Mohan Malviya Cancer Centre
  • Israel
      • Beer Yaakov, Israel, 70300
        • Recruiting
        • Yitzhak Shamir Medical Center
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Medical Center
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah University Hospita Ein Kerem
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
      • Ramat Gan, Israel, 52621
        • Completed
        • Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
      • Tel Aviv, Israel, 69710
        • Recruiting
        • Assuta MC
  • Italy
      • Meldola, Italy, 47014
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • 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
  • 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
      • 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
      • Cheras, Malaysia, 56000
        • Recruiting
        • Hospital Canselor Tuanku Muhriz UKM
      • 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
        • National Cancer Institute
  • 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, 5022 GC
        • Recruiting
        • Elisabeth-Tweesteden Ziekenhuis
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • UMC Utrecht
  • 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, 02 781
        • Recruiting
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Puerto Rico
      • Barrio Monacillos, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials LLC
  • 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, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea Seoul St Marys Hospital
  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hosp. de La Santa Creu I Sant Pau
      • 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
      • 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 University Hospital
      • 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, 83301
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10043
        • Recruiting
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Linkou Chang Gung Memorial 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
      • 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
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Addenbrooke's Hospital
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • Western General 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, NW1 2BU
        • Recruiting
        • University College Hospital
      • Northwood, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Centre
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital (Sutton)
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
    • 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
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University School of Medicine
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown Univ Medical Center Lombardi Cancer Center
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists South
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth Medical Group Oncology and Hematology at Orlando
      • 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
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Memorial Hospital
      • 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
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Fort Wayne Medical Oncology & Hematology
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospital
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • Mission Cancer Blood
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Cancer Center of Kansas
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • MedStar Franklin Square Medical Center
      • Frederick, Maryland, United States, 21702-4337
        • Recruiting
        • Frederick Health Hospital - James M Stockman Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • VA Ann Arbor Healthcare System
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Start Midwest
    • 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 Midwest Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico Cancer Center
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Long Island
      • New York, New York, United States, 10003
        • Recruiting
        • Mount Sinai
      • New York, New York, United States, 10032
        • Recruiting
        • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center NYU Hematology Associates
      • New York, New York, United States, 10009
        • Recruiting
        • Mount Sinai West
      • 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
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Taussig Cancer Insititute Cleveland Clinic
      • Cleveland, Ohio, United States, 44111
        • Recruiting
        • Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
      • Independence, Ohio, United States, 44131
        • Recruiting
        • Cleveland Clinic Cancer Center Independence Family Health Center
      • Mansfield, Ohio, United States, 44906
        • Recruiting
        • Cleveland Clinic Cancer Center Mansfield
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Cleveland Clinic Cancer Center Hillcrest Hospital
      • Sandusky, Ohio, United States, 44870
        • Recruiting
        • Cleveland Clinic Cancer Centers Sandusky
      • Strongsville, Ohio, United States, 44136
        • Recruiting
        • Cleveland Clinic Cancer Center Strongsville
      • Warrensville Heights, Ohio, United States, 44122
        • Recruiting
        • Cleveland Clinic Cancer Center South Pointe Hospital
      • Wooster, Ohio, United States, 44691
        • Recruiting
        • Wooster Milltown Specialty and Surgery Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
    • Pennsylvania
      • 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
      • 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
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology DFW
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
      • Round Rock, Texas, United States, 78665
        • Recruiting
        • Baylor Scott and White Health 1
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott and White Health
    • Virginia
      • Arlington, Virginia, United States, 22201
        • Recruiting
        • Virginia Cancer Specialists
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute Dept of Fairfax Hospital
      • Richmond, Virginia, United States, 23249
        • Recruiting
        • Richmond VA Medical Center
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute Edmonds
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute Issaquah
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • William S. Middleton Memorial VA

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 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
  • Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (>) 12 months prior to CRC recurrence/metastases
  • Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1

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: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) 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 and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor
  • Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)

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 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.
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.
Drug: Oxaliplatin
Oxaliplatin will be administered as chemotherapy regimen.
Drug: Irinotecan Hydrochloride
Irinotecan hydrochloride will be administered as chemotherapy regimen.
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.
Drug: 5-fluorouracil
5-fluorouracil will be administered as chemotherapy regimen.
Drug: Leucovorin calcium/Levoleucovorin
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Drug: Oxaliplatin
Oxaliplatin will be administered as chemotherapy regimen.
Drug: Irinotecan Hydrochloride
Irinotecan hydrochloride will be administered as chemotherapy regimen.
Biological: Cetuximab
Cetuximab will be administered.
Other Names:
  • Erbitux

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 4 years and 2 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 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 4 years and 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 7 Years 3 Months
OS is defined as the time from the date of randomization to the date of participant's death due to any cause. Any participant not known to have died at the time of analysis will be censored based on the last recorded date on which the participant was known to be alive.
Up to 7 Years 3 Months
Objective Response Rate (ORR) as Assessed by Investigator
Time Frame: Up to 7 Years 3 Months
ORR is defined as the percentage of randomized participants achieving complete CR or PR, as assessed by the investigator.
Up to 7 Years 3 Months
Duration of Response (DOR) as Assessed by BICR
Time Frame: Up to 7 Years 3 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 using RECIST v1.1 criteria.
Up to 7 Years 3 Months
Duration of Response (DOR) as Assessed Investigator
Time Frame: Up to 7 Years 3 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 the investigator.
Up to 7 Years 3 Months
Progression-free Survival After Subsequent Therapy (PFS2)
Time Frame: Up to 7 Years 3 Months
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first.
Up to 7 Years 3 Months
Disease Control Rate (DCR) as Assessed by BICR
Time Frame: Up to 7 Years 3 Months
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by BICR using RECIST v1.1 criteria.
Up to 7 Years 3 Months
Disease Control Rate (DCR) as Assessed by Investigator
Time Frame: Up to 7 Years 3 Months
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by the investigator.
Up to 7 Years 3 Months
Time to Treatment Failure
Time Frame: Up to 7 Years 3 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 7 Years 3 Months
Number of Participants with Adverse Events (AEs) by Severity
Time Frame: Up to 7 Years 3 Months
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. AE severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) v5.0. by using the standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant 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 7 Years 3 Months
Number of Participants with Abnormalities in Laboratory Values
Time Frame: Up to 7 Years 3 Months
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
Up to 7 Years 3 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 7 Years 3 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 7 Years 3 Months
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
Time Frame: Up to 7 Years 3 Months
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the 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 symptom.
Up to 7 Years 3 Months
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29
Time Frame: Up to 7 Years 3 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.
Up to 7 Years 3 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 7 Years 3 Months
The 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 indicate severe side effects.
Up to 7 Years 3 Months
Progression Free Survival (PFS) as Assessed by Investigator
Time Frame: Up to 7 Years 3 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 the investigator. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable disease assessment date.
Up to 7 Years 3 Months
Objective Response Rate (ORR) as Assessed by BICR
Time Frame: Up to 7 Years 3 Months
ORR is defined as the proportion of randomized participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria. BOR is defined as best response recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent systemic anti cancer therapy or date of curative-intent procedure, whichever occurs first.
Up to 7 Years 3 Months
Time to Response (TTR) as Assessed by BICR
Time Frame: Up to 7 Years 3 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 7 Years 3 Months
Time to Response as Assessed by Investigator
Time Frame: Up to 7 Years 3 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 7 Years 3 Months
Curative Resection (R0) Rate
Time Frame: Up to 7 Years 3 Months
Curative resection (R0) rate is defined as the proportion of participants from the analysis set who underwent curative-intent surgery, where the residual tumor classification was R0.
Up to 7 Years 3 Months
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC-QLQ-C29) Score
Time Frame: From Baseline up to 7 Years 3 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 7 Years 3 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)

October 18, 2024

Primary Completion (Estimated)

December 15, 2028

Study Completion (Estimated)

January 20, 2032

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 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

  • 61186372COR3001 (Janssen Research & Development, LLC)
  • 2024-513852-13-00 (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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