Skip to main content
Home
 
 
 
MENU
Home
Janssen’s COVID-19 Vaccine Status >

Janssen Global Main Menu

  • Our Company
    • About Us
    • Contact Us
    • Grants & Giving
    • News Center
    • Our Leaders
    • Patient Safety information
    • Products
    • Sustainability
    • Transparency
    • VISIT JANSSEN IN YOUR COUNTRY
  • Our Focus
    • Therapeutic Areas
    • Cardiovascular, Metabolism and Retina
    • Immunology
    • Infectious Diseases & Vaccines
    • Neuroscience
    • Oncology
    • Pulmonary Hypertension
    • Patient Engagement
  • Our Science
    • Our Response to COVID-19
    • Clinical Trials
    • Compassionate Use & Pre-Approval Access
    • R&D Data Science
    • Janssen Global Trial Finder
    • World Without Disease Accelerator
    • Janssen Clinical Innovation
    • Precision Medicine & Janssen Diagnostics

Our Stories List

Making a Splash for Disease Awareness
Global_Trial_Finder
Making a Splash for Disease Awareness
Looking Under the Hood for Green Chemistry Solutions
Global_Trial_Finder
Looking Under the Hood for Green Chemistry Solutions
  • Return to home

Global Trial Finder

  • text size

My Saved Trials

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)

Last Updated   May 14, 2025

Want to learn how to participate in this trial?

61186372COR3002

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 3
  • Sites
    168 Sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.

CONDITIONS

  • Colorectal Neoplasms

ELIGIBILITY


Inclusion Criteria:

* Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
* Be diagnosed to have KRAS, NRAS, and BRAF wild-type (WT) tumor as determined by local 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 RECIST v1.1
* 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


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 unlikely 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)


Inclusion Criteria:

* Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
* Be diagnosed to have KRAS, NRAS, and BRAF wild-type (WT) tumor as determined by local testing
* Mu

More...

DETAILS

LOCATIONS

Locations in:
United States, Australia, Belgium, Brazil, China, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, South Korea, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, Romania, Spain, Sweden, Taiwan, Thailand, Türkiye, United Kingdom
Country (26) City or Province (168) Status
United States Chandler Ironwood Cancer and Research Center
RECRUITING
United States Jonesboro St. Bernard's Medical Center
RECRUITING
United States Bakersfield CBCC Global Research
RECRUITING
United States Los Alamitos Cancer and Blood Specialty Clinic
RECRUITING
United States Los Angeles USC Norris Comprehensive Cancer Center
RECRUITING
United States Santa Rosa Providence Medical Foundation
RECRUITING
United States Torrance Torrance Memorial Physicians Network
RECRUITING
United States Aurora University of Colorado Denver Anschultz Medical Campus
RECRUITING
United States Norwich Eastern Connecticut Hematology & Oncology Assoc.
RECRUITING
United States Miami Beach Mount Sinai Medical Center Campus
RECRUITING
United States Orlando AdventHealth Cancer Institute
RECRUITING
United States Atlanta Grady Memorial Hospital
RECRUITING
United States Atlanta Winship Cancer Institute Emory University
RECRUITING
United States Baton Rouge Mary Bird Perkins Cancer Center
RECRUITING
United States Baltimore MedStar Franklin Square Medical Center
RECRUITING
United States Grand Rapids Cancer And Hematology Centers of Western Michigan PC
RECRUITING
United States Hattiesburg Hattiesburg Clinic
RECRUITING
United States Saint Louis Washington University School Of Medicine
RECRUITING
United States Omaha Nebraska Cancer Specialists
RECRUITING
United States East Brunswick Astera Cancer Care
RECRUITING
United States Shirley New York Cancer and Blood Specialists
RECRUITING
United States Philadelphia Fox Chase Cancer Center
RECRUITING
United States Nashville Tennessee Oncology
RECRUITING
United States Houston MD Anderson Cancer Center
RECRUITING
United States Temple Scott And White Memorial Hospital
RECRUITING
United States Lacey Providence Regional Cancer System
RECRUITING
Australia Concord Concord Hospital
RECRUITING
Australia Heidelberg Warringal Private Hospital
RECRUITING
Australia South Woodville Queen Elizabeth Hospital
RECRUITING
Australia St Albans Western Health Sunshine Hospital
RECRUITING
Belgium Anderlecht Institut Jules Bordet
RECRUITING
Belgium Edegem UZ Antwerpen
RECRUITING
Belgium Gent AZ Maria Middelares
RECRUITING
Belgium Haine Saint Paul La Louviere Jolimont
RECRUITING
Belgium Kortrijk Az Groeninge
RECRUITING
Belgium Leuven Universitair Ziekenhuis Leuven
RECRUITING
Brazil Barretos Fundacao Pio XII
RECRUITING
Brazil Caxias do Sul Fundacao Universidade de Caxias do Sul
RECRUITING
Brazil Jau Fundacao Doutor Amaral Carvalho
RECRUITING
Brazil Salvador Hospital Santa Izabel Santa Casa de Misericordia da Bahia
RECRUITING
Brazil Sao Jose do Rio Preto Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
RECRUITING
Brazil Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
Brazil Vitoria Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
RECRUITING
China Beijing Peking University First Hospital
RECRUITING
China Beijing Beijing Friendship Hospital Capital Medical University
RECRUITING
China Beijing Beijing Cancer Hospital
RECRUITING
China Chengdu West China Hospital of Sichuan University
RECRUITING
China Ganzhou Ganzhou Cancer Hospital
RECRUITING
China Guangzhou Sun Yat Sen University Cancer Center
RECRUITING
China Guangzhou The Sixth Affiliated Hospital Sun Yat sen University
RECRUITING
China Guangzhou Guangdong Provincial People's Hospital
RECRUITING
China Hangzhou The Second Affiliated Hospital of Zhejiang University
RECRUITING
China Hangzhou Zhejiang Cancer Hospital
RECRUITING
China Huizhou Huizhou Central People's Hospital
RECRUITING
China Lanzhou Gansu Provincial Cancer Hospital
RECRUITING
China Nanchang The First Affiliated Hospital of NanChang University
RECRUITING
China Shanghai Fudan University Shanghai Cancer Center
RECRUITING
China Tianjin Tianjin Medical University Cancer Institute and Hospital
RECRUITING
China Wuhan Hubei Cancer Hospital
RECRUITING
France Avignon Cedex 9 Institut Sainte Catherine
RECRUITING
France Pessac Hopital Haut Leveque
RECRUITING
France Poitiers Cedex CHU De Poitiers
RECRUITING
Germany Berlin Charite Universitatsmedizin Berlin Campus Virchow Klinikum
RECRUITING
Germany Frankfurt am Main Krankenhaus NorthWest
RECRUITING
Germany Munich Klinikum der Universitaet Muenchen
RECRUITING
Hong Kong Shatin Prince Of Wales Hospital
RECRUITING
Hungary Eger Markhot Ferenc Oktatokorhaz es Rendelointezet
RECRUITING
Hungary Pecs Pecsi Tudomanyegyetem
RECRUITING
India Delhi Rajiv Gandhi Cancer Institute and Research Centre
RECRUITING
India Hyderabad Asian Institute Of Gastroenterology
RECRUITING
India Kolkata B P Poddar Hospital and Medical research Limited
RECRUITING
India Mumbai Tata Memorial Hospital
RECRUITING
India Pune Deenanath Mangeshkar Hospital and Research Centre
RECRUITING
India Vellore Christian medical
RECRUITING
Israel Beer Yaakov Yitzhak Shamir Medical Center
RECRUITING
Israel Haifa Rambam Medical Center
RECRUITING
Israel Jerusalem Hadassah Medical Center
RECRUITING
Israel Petach Tikva Rabin Medical Center
RECRUITING
Israel Ramat Gan Sheba Medical Center
RECRUITING
Israel Tel Aviv Yafo Tel Aviv Sourasky Medical Center
RECRUITING
Israel Tel Aviv Assuta MC
RECRUITING
Italy Milano Istituto Dei Tumori Di Milano
RECRUITING
Italy Padova Istituto Oncologico Veneto - IRCCS
RECRUITING
Italy Pisa Azienda Ospedaliero Universitaria Pisana
RECRUITING
Italy Rozzano Istituto Clinico Humanitas
RECRUITING
Italy Udine Azienda Sanitaria Universitaria Friuli Centrale ASU FC
RECRUITING
Japan Chiba Chiba Cancer Center
RECRUITING
Japan Chuo Ku National Cancer Center Hospital
RECRUITING
Japan Kashiwa National Cancer Center Hospital East
RECRUITING
Japan Nagoya Shi Aichi Cancer Center
RECRUITING
Japan Osaka City Osaka International Cancer Institute
RECRUITING
Japan Osaka Sayama shi Kindai University Hospital
RECRUITING
Japan Osaka-Shi National Hospital Organization Osaka National Hospital
RECRUITING
Japan Suita-shi Osaka University Hospital
RECRUITING
Japan Tokyo The Cancer Institute Hospital of JFCR
RECRUITING
South Korea Daegu Kyungpook National University Chilgok Hospital
RECRUITING
South Korea Seoul Korea University Anam Hospital
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
South Korea Seoul Severance Hospital Yonsei University Health System
RECRUITING
South Korea Seoul Asan Medical Center
RECRUITING
South Korea Seoul Samsung Medical Center
RECRUITING
South Korea Seoul The Catholic University of Korea Seoul St Mary s Hospital
RECRUITING
Malaysia Georgetown Hospital Pulau Pinang
RECRUITING
Malaysia Ipoh Hospital Raja Permaisuri Bainun
RECRUITING
Malaysia Kuala Lumpur Hospital Kuala Lumpur
RECRUITING
Malaysia Kuala Lumpur University Malaya Medical Centre
RECRUITING
Malaysia Kuching Hospital Umum Sarawak
RECRUITING
Malaysia Putrajaya Institut Kanser Negara Clinical Research Center
RECRUITING
Mexico Chihuahua Centro Oncologico de Chihuahua
RECRUITING
Mexico Ciudad de Mexico Centro Oncologico Personalizado Cope S De R L De C V
RECRUITING
Mexico Guadalajara Actualidad Basada En La Investigacion Del Cancer
RECRUITING
Mexico Puebla Oncocenter
RECRUITING
Mexico Queretaro Cuidados Oncologicos
RECRUITING
Mexico Queretaro Health Pharma Queretaro SA de CV
RECRUITING
Netherlands Amersfoort Meander Medisch Centrum
RECRUITING
Netherlands Nijmegen Radboud University Medical Center
RECRUITING
Netherlands Rotterdam Erasmus MC
RECRUITING
Netherlands Tilburg ETZ TweeSteden
RECRUITING
Poland Biala Podlaska Wojewodzki Szpital Specjalistyczny
RECRUITING
Poland Bialystok Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
RECRUITING
Poland Brzozow Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
RECRUITING
Poland Gdansk Uniwersyteckie Centrum Kliniczne
RECRUITING
Poland Gliwice Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
RECRUITING
Poland Lodz Instytut Centrum Zdrowia Matki Polki
RECRUITING
Poland Olsztyn SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie
RECRUITING
Poland Opole SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
RECRUITING
Poland Warszawa Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
RECRUITING
Puerto Rico San Juan Pan American Center for Oncology Trials LLC
RECRUITING
Romania Brasov Centrul Medical Unirea SRL
RECRUITING
Romania Bucuresti Ponderas Academic Hospital
RECRUITING
Romania Craiova Clinica de Oncologie Sf Nectarie
RECRUITING
Spain Barcelona Hosp. de La Santa Creu I Sant Pau
RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Spain Madrid Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Spain Madrid Hosp. Univ. Ramon Y Cajal
RECRUITING
Spain Madrid Hosp. Univ. 12 de Octubre
RECRUITING
Spain Pamplona Clinica Univ. de Navarra
RECRUITING
Spain Sevilla Hosp. Virgen Del Rocio
RECRUITING
Spain Valencia Hosp. Clinico Univ. de Valencia
RECRUITING
Sweden Gothenburg Sahlgrenska Universitetssjukhuset
RECRUITING
Sweden Lund Skanes universitetssjukhus
RECRUITING
Sweden Stockholm Sodersjukhuset
RECRUITING
Sweden Stockholm Karolinska Universitetssjukhuset
RECRUITING
Sweden Uppsala Uppsala University
RECRUITING
Taiwan Kaohsiung City Chang Gung Memorial Hospital
RECRUITING
Taiwan Kaohsiung Kaohsiung Medical University Chung Ho Memorial Hospital
RECRUITING
Taiwan Taichung Taichung Veterans General Hospital
RECRUITING
Taiwan Tainan National Cheng Kung University Hospital
RECRUITING
Taiwan Taipei National Taiwan University Hospital
RECRUITING
Taiwan Taipei Taipei Veterans General Hospital
RECRUITING
Taiwan Taoyuan Linkou Chang Gung Memorial Hospital
RECRUITING
Thailand Bangkok Ramathibodi Hospital
RECRUITING
Thailand Bangkok Siriraj Hospital
RECRUITING
Thailand Chiang Mai Chiang Mai University
RECRUITING
Thailand Songkhla Songklanagarind hospital
RECRUITING
Türkiye Ankara Gulhane Egitim ve Arastirma Hastanesi
RECRUITING
Türkiye Ankara Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING
Türkiye Ankara Gazi University Hospital
RECRUITING
Türkiye Istanbul Bakirkoy Training and Research Hospital
RECRUITING
Türkiye İstanbul Marmara University Pendik Training Hospital
RECRUITING
Türkiye Konya Necmettin Erbakan University Meram Medical Faculty
RECRUITING
Türkiye Sakarya Sakarya University Training and Research Hospital
RECRUITING
United Kingdom Hull Castle Hill Hospital
RECRUITING
United Kingdom Leeds St James University Hospital
RECRUITING
United Kingdom London St Bartholomew's Hospital
RECRUITING
United Kingdom London University College Hospital
RECRUITING
United Kingdom London Royal Marsden Hospital
RECRUITING
United Kingdom Northwood Mount Vernon Cancer Centre
RECRUITING
Show More
Geo Locations

33.30616, -111.84125

35.8423, -90.70428

35.37329, -119.01871

33.80307, -118.07256

34.05223, -118.24368

38.44047, -122.71443

33.83585, -118.34063

39.72943, -104.83192

41.52426, -72.07591

25.79065, -80.13005

28.53834, -81.37924

33.749, -84.38798

33.749, -84.38798

30.45075, -91.15455

39.29038, -76.61219

42.96336, -85.66809

31.32712, -89.29034

38.62727, -90.19789

41.25626, -95.94043

40.42788, -74.41598

40.80149, -72.8676

39.95233, -75.16379

36.16589, -86.78444

29.76328, -95.36327

31.09823, -97.34278

47.03426, -122.82319

-33.84722, 151.10381

-37.75, 145.06667

-34.8789633, 138.5369358

-37.73901, 144.80024

50.83619, 4.31454

51.15662, 4.44504

51.05, 3.71667

50.45313, 4.19126

50.82803, 3.26487

50.87959, 4.70093

-20.55722, -48.56778

-29.16806, -51.17944

-22.29639, -48.55778

-12.97111, -38.51083

-20.81972, -49.37944

-23.5475, -46.63611

-20.31944, -40.33778

39.9075, 116.39723

39.9075, 116.39723

39.9075, 116.39723

30.66667, 104.06667

25.8528899, 114.94

23.11667, 113.25

23.11667, 113.25

23.11667, 113.25

30.29365, 120.16142

30.29365, 120.16142

23.11147, 114.41523

36.05701, 103.83987

28.68396, 115.85306

31.22222, 121.45806

39.14222, 117.17667

30.58333, 114.26667

43.94834, 4.80892

44.81011, -0.64129

46.58333, 0.33333

52.52437, 13.41053

50.11552, 8.68417

48.13743, 11.57549

22.38333, 114.18333

47.90265, 20.37329

46.08333, 18.23333

28.65195, 77.23149

17.38405, 78.45636

22.56263, 88.36304

19.07283, 72.88261

18.51957, 73.85535

12.9184, 79.13255

31.943507, 34.83904

32.81841, 34.9885

31.76904, 35.21633

32.08707, 34.88747

32.08227, 34.81065

32.08088, 34.78057

32.08088, 34.78057

45.46427, 9.18951

45.40797, 11.88586

43.70853, 10.4036

45.38193, 9.1559

46.0693, 13.23715

35.6, 140.11667

35.57779, 139.71685

35.86224, 139.97732

35.18147, 136.90641

34.69374, 135.50218

34.69374, 135.50218

34.69374, 135.50218

34.76143, 135.51567

35.6895, 139.69171

35.87028, 128.59111

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

5.4197312, 100.3170452

4.5841, 101.0829

3.1412, 101.68653

3.1412, 101.68653

1.54999, 110.33333

2.93527, 101.69112

28.63528, -106.08889

19.42847, -99.12766

20.66682, -103.39182

19.03793, -98.20346

20.591681, -100.39752

20.6976975, -100.4452756

52.155, 5.3875

51.8425, 5.85278

51.9225, 4.47917

51.55551, 5.0913

52.03238, 23.11652

53.13333, 23.16433

49.69501, 22.01926

54.35205, 18.64637

50.29761, 18.67658

51.75, 19.46667

53.77995, 20.49416

50.67211, 17.92533

52.22977, 21.01178

18.46633, -66.10572

45.64861, 25.60613

44.42802, 26.09665

44.31667, 23.8

41.38879, 2.15899

41.38879, 2.15899

40.4165, -3.70256

40.4165, -3.70256

40.4165, -3.70256

42.81687, -1.64323

37.38283, -5.97317

39.46975, -0.37739

57.70716, 11.96679

55.70584, 13.19321

59.33258, 18.0649

59.33258, 18.0649

59.85882, 17.63889

22.61626, 120.31333

22.61626, 120.31333

24.1469, 120.6839

22.99083, 120.21333

25.04776, 121.53185

25.04776, 121.53185

24.95233, 121.20193

13.75398, 100.50144

13.75398, 100.50144

18.79038, 98.98468

7.19882, 100.5951

39.91987, 32.85427

39.91987, 32.85427

39.91987, 32.85427

41.01384, 28.94966

41.01384, 28.94966

37.87135, 32.48464

40.853906, 30.2820542

53.7446, -0.33525

53.79648, -1.54785

51.50853, -0.12574

51.50853, -0.12574

51.50853, -0.12574

51.6149258, -0.4458015

x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

Interested in participating?

×

Confirm


If you are interested in this clinical trial, we will use your email address to respond to your questions and fulfill your requests as necessary for our legitimate interest and possibly to comply with our legal obligations relating to pharmacovigilance. Please read our Privacy Policy.

Footer

  • PRIVACY POLICY
  • LEGAL NOTICE
  • COOKIE POLICY
  • COOKIE SETTINGS
  • CAREERS
  • NEWS CENTER
  • DO NOT SELL MY PERSONAL INFORMATION

Footer Social

Find Janssen Global on:

twitter youtube linkedin

Janssen Global Policy text

©Johnson & Johnson Innovative Medicine. All Rights Reserved. This website is hosted and operated by Johnson & Johnson Innovative Medicine, which is solely responsible for its content. This website is intended for a global audience.