Een onderzoek naar amivantamab en mFOLFOX6 of FOLFIRI versus Cetuximab en mFOLFOX6 of FOLFIRI als eerstelijnsbehandeling bij deelnemers met KRAS/NRAS en BRAF Wildtype niet-reseceerbare of gemetastaseerde linkszijdige colorectale kanker (OrigAMI-2)
Een gerandomiseerde, open-label fase 3-studie van Amivantamab en mFOLFOX6 of FOLFIRI versus Cetuximab en mFOLFOX6 of FOLFIRI als eerstelijnsbehandeling bij deelnemers met KRAS/NRAS en BRAF Wildtype niet-reseceerbare of gemetastaseerde linkszijdige colorectale kanker
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Uitgebreide toegang
Contacten en locaties
Studiecontact
- Naam: Study Contact
- Telefoonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studie Locaties
-
-
-
Anderlecht, België, 1070
- Werving
- Institut Jules Bordet
-
Edegem, België, 2650
- Werving
- Universitair Ziekenhuis Antwerpen
-
Ghent, België, 9000
- Actief, niet wervend
- AZ Maria Middelares
-
Haine Saint Paul La Louviere, België, 7100
- Werving
- Hopital de Jolimont
-
Kortrijk, België, 8500
- Werving
- Az Groeninge
-
Leuven, België, 3000
- Werving
- Universitair Ziekenhuis Leuven
-
Liège, België, 4000
- Werving
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
-
-
-
-
-
Barretos, Brazilië, 14780 070
- Werving
- Fundacao Pio XII
-
Caxias do Sul, Brazilië, 95070 560
- Werving
- Fundacao Universidade de Caxias do Sul
-
Jaú, Brazilië, 17210 080
- Werving
- Fundacao Doutor Amaral Carvalho
-
Porto Alegre, Brazilië, 91350 200
- Werving
- Hospital Nossa Senhora da Conceicao S A
-
Salvador, Brazilië, 40050 410
- Werving
- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
-
Santa Maria, Brazilië, 97015 450
- Werving
- Clinica de Hematologia e Oncologia Viver Ltda
-
São José do Rio Preto, Brazilië, 15090-000
- Werving
- Funfarme Sjrp
-
São Paulo, Brazilië, 01246 000
- Werving
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
-
São Paulo, Brazilië, 01509 900
- Werving
- Fundacao Antonio Prudente A C Camargo Cancer Center
-
São Paulo, Brazilië, 05651 900
- Werving
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
-
Vitória, Brazilië, 29043 260
- Werving
- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 5G2
- Werving
- Arthur J E Child Comprehensive Cancer Centre
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- Werving
- Ottawa Hospital
-
Toronto, Ontario, Canada, M5G1X6
- Werving
- Princess Margaret Cancer Centre
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 0C1
- Werving
- Centre de Recherche du CHUM
-
-
-
-
-
Beijing, China, 100191
- Werving
- Peking University Third Hospital
-
Beijing, China, 100142
- Werving
- Beijing Cancer Hospital
-
Beijing, China, 100034
- Werving
- Peking University First Hospital
-
Beijing, China, 100050
- Werving
- Beijing Friendship Hospital Capital Medical University
-
Changchun, China, 130021
- Werving
- The First Bethune Hospital of Jilin University
-
Changsha, China, 410013
- Werving
- Hunan Cancer hospital
-
Guangzhou, China, 510655
- Werving
- The Sixth Affiliated Hospital Sun Yat sen University
-
Guangzhou, China, 519041
- Werving
- Guangdong Provincial People's Hospital
-
Guangzhou, China, 510062
- Werving
- Sun Yat Sen University Cancer Center
-
Hangzhou, China, 310009
- Werving
- The Second Affiliated Hospital of Zhejiang University College of Medicine
-
Hangzhou, China, 310022
- Werving
- Zhejiang Cancer Hospital
-
Hangzhou, China, 310003
- Werving
- The First Affiliated Hospital Zhejiang University College of Medicine
-
Harbin, China, 150081
- Werving
- Harbin medical university cancer hospital
-
Huizhou, China, 516001
- Werving
- Huizhou Central People's Hospital
-
Nanchang, China, 330006
- Werving
- The First Affiliated Hospital of NanChang University
-
Shanghai, China, 200032
- Werving
- Fudan University Shanghai Cancer Center
-
Shenyang, China, 110042
- Werving
- Liaoning Cancer Hospital and Institute
-
Shenzhen, China, 518036
- Werving
- Peking University Shenzhen Hospital
-
Sichuan, China, 610044
- Werving
- West China Hospital of Sichuan University
-
Taiyuan, China, 030001
- Werving
- First Hospital of Shanxi Medical University
-
Tianjin, China, 300060
- Werving
- Tianjin Medical University Cancer Institute and Hospital
-
Wuhan, China, 430079
- Werving
- Hubei Cancer Hospital
-
-
-
-
-
Berlin, Duitsland, 13353
- Werving
- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
-
Dresden, Duitsland, 01307
- Werving
- Universitaetsklinikum Carl Gustav Carus TU Dresden
-
Essen, Duitsland, 45147
- Werving
- Essen University Hospital
-
Frankfurt am Main, Duitsland, 60488
- Werving
- Krankenhaus NorthWest
-
Freiburg im Breisgau, Duitsland, 79110
- Werving
- Praxis fur interdisziplinare Onkologie & Hamatologie GbR
-
Hamburg, Duitsland, 22763
- Werving
- Asklepios Klinik Altona
-
Heidelberg, Duitsland, 69120
- Werving
- National Center for Tumor Diseases NCT
-
Mainz, Duitsland, 55131
- Werving
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
-
Munich, Duitsland, 81377
- Werving
- Klinikum der Universitaet Muenchen
-
Ulm, Duitsland, 89081
- Werving
- Universitatsklinikum Ulm
-
-
-
-
-
Avignon, Frankrijk, 84918
- Werving
- Institut Sainte Catherine
-
Lille, Frankrijk, 59000
- Werving
- Hopital Claude Huriez
-
Lyon, Frankrijk, 69008
- Werving
- Hopital Prive Jean Mermoz
-
Montpellier, Frankrijk, 34298
- Werving
- Institut du Cancer de Montpellier
-
Nantes, Frankrijk, 44000
- Werving
- CHU Nantes
-
Paris, Frankrijk, 75571
- Werving
- Hopital Saint Antoine
-
Pessac, Frankrijk, 33604
- Werving
- Hopital Haut Leveque
-
Poitiers, Frankrijk, 86000
- Werving
- CHU De Poitiers
-
Villejuif, Frankrijk, 94805
- Werving
- Gustave Roussy
-
-
-
-
-
Budapest, Hongarije, 1082
- Werving
- Semmelweis Egyetem
-
Eger, Hongarije, 3300
- Werving
- Markhot Ferenc Oktatokorhaz es Rendelointezet
-
Pécs, Hongarije, 7624
- Voltooid
- Pecsi Tudomanyegyetem
-
Szeged, Hongarije, 6720
- Werving
- Szegedi Tudomanyegyetem
-
-
-
-
-
Delhi, Indië, 110085
- Werving
- Rajiv Gandhi Cancer Institute and Research Centre
-
Kolkata, Indië, 700053
- Werving
- B P Poddar Hospital and Medical research Limited
-
Mumbai, Indië, 400012
- Werving
- Tata Memorial Hospital
-
Pune, Indië, 411004
- Werving
- Deenanath Mangeshkar Hospital and Research Centre
-
Varanasi, Indië, 221005
- Werving
- Mahamana Pandit Madan Mohan Malviya Cancer Centre
-
-
-
-
-
Beer Yaakov, Israël, 70300
- Werving
- Yitzhak Shamir Medical Center
-
Haifa, Israël, 3109601
- Werving
- Rambam Medical Center
-
Jerusalem, Israël, 9112001
- Werving
- Hadassah University Hospita Ein Kerem
-
Petah Tikva, Israël, 4941492
- Werving
- Rabin Medical Center
-
Ramat Gan, Israël, 52621
- Voltooid
- Sheba Medical Center
-
Tel Aviv, Israël, 6423906
- Werving
- Tel Aviv Sourasky Medical Center
-
Tel Aviv, Israël, 69710
- Werving
- Assuta MC
-
-
-
-
-
Meldola, Italië, 47014
- Werving
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
-
Milan, Italië, 20133
- Werving
- Istituto Dei Tumori Di Milano
-
Padova, Italië, 35128
- Werving
- Istituto Oncologico Veneto - IRCCS
-
Pisa, Italië, 56126
- Werving
- Azienda Ospedaliero Universitaria Pisana
-
Rozzano, Italië, 20089
- Werving
- Istituto Clinico Humanitas
-
-
-
-
-
Chiba, Japan, 260 0801
- Werving
- Chiba Cancer Center
-
Chūōku, Japan, 104 0045
- Werving
- National Cancer Center Hospital
-
Kashiwa, Japan, 277 8577
- Werving
- National Cancer Center Hospital East
-
Nagoya, Japan, 464-8681
- Werving
- Aichi Cancer Center
-
Osaka, Japan, 541 8567
- Werving
- Osaka International Cancer Institute
-
Osaka, Japan, 540 0006
- Werving
- National Hospital Organization Osaka National Hospital
-
Shizuoka, Japan, 411 8777
- Werving
- Shizuoka Cancer Center
-
Suita, Japan, 565 0871
- Werving
- The University of Osaka Hospital
-
Tokyo, Japan, 135 8550
- Werving
- The Cancer Institute Hospital of JFCR
-
-
-
-
-
Cheras, Maleisië, 56000
- Werving
- Hospital Canselor Tuanku Muhriz UKM
-
George Town, Maleisië, 10450
- Werving
- Hospital Pulau Pinang
-
Ipoh, Maleisië, 30450
- Werving
- Hospital Raja Permaisuri Bainun
-
Kuala Lumpur, Maleisië, 59100
- Werving
- University Malaya Medical Centre
-
Kuala Lumpur, Maleisië, 50586
- Werving
- Hospital Kuala Lumpur
-
Kuching, Maleisië, 93586
- Werving
- Hospital Umum Sarawak
-
Putrajaya, Maleisië, 62250
- Werving
- National Cancer Institute
-
-
-
-
-
Amersfoort, Nederland, 3813 TZ
- Werving
- Meander Medisch Centrum
-
Amsterdam, Nederland, 1066 CX
- Werving
- Antoni van Leeuwenhoek
-
Nijmegen, Nederland, 6525 GA
- Werving
- Radboud University Medical Center
-
Rotterdam, Nederland, 3015 GD
- Werving
- Erasmus MC
-
Tilburg, Nederland, 5022 GC
- Werving
- Elisabeth-TweeSteden Ziekenhuis
-
Utrecht, Nederland, 3584 CX
- Werving
- UMC Utrecht
-
-
-
-
-
Bialystok, Polen, 15 027
- Werving
- Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
-
Biała Podlaska, Polen, 21 500
- Voltooid
- Wojewodzki Szpital Specjalistyczny
-
Brzozów, Polen, 36 200
- Werving
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
-
Gdansk, Polen, 80 214
- Werving
- Uniwersyteckie Centrum Kliniczne
-
Gliwice, Polen, 44 100
- Werving
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
-
Lodz, Polen, 93 339
- Voltooid
- Instytut Centrum Zdrowia Matki Polki
-
Olsztyn, Polen, 10 228
- Werving
- Szpital Kliniczny MSWiA z WMCO
-
Opole, Polen, 45 061
- Werving
- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
-
Warsaw, Polen, 02 781
- Werving
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
-
-
-
-
-
Barrio Monacillos, Puerto Rico, 00935
- Werving
- Pan American Center for Oncology Trials LLC
-
-
-
-
-
Barcelona, Spanje, 08041
- Werving
- Hosp. de La Santa Creu I Sant Pau
-
Barcelona, Spanje, 08035
- Werving
- Hosp Univ Vall D Hebron
-
Madrid, Spanje, 28034
- Werving
- Hosp. Univ. Ramon Y Cajal
-
Madrid, Spanje, 28041
- Werving
- Hosp. Univ. 12 de Octubre
-
Madrid, Spanje, 28007
- Werving
- Hosp. Gral. Univ. Gregorio Maranon
-
Pamplona, Spanje, 31008
- Werving
- Clinica Univ. de Navarra
-
Seville, Spanje, 41013
- Werving
- Hosp. Virgen Del Rocio
-
Valencia, Spanje, 46010
- Werving
- Hosp. Clinico Univ. de Valencia
-
-
-
-
-
Kaohsiung City, Taiwan, 83301
- Werving
- Kaohsiung Chang Gung Memorial Hospital
-
Kaohsiung City, Taiwan, 80756
- Werving
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Tainan, Taiwan, 704
- Werving
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 10043
- Werving
- National Taiwan University Hospital
-
Taoyuan, Taiwan, 333
- Werving
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Adana, Turkije (Türkiye), 01060
- Werving
- Adana City Hospital
-
Ankara, Turkije (Türkiye), 06800
- Werving
- Ankara Bilkent Sehir Hastanesi
-
Ankara, Turkije (Türkiye), 06010
- Werving
- Gulhane Egitim ve Arastirma Hastanesi
-
Ankara, Turkije (Türkiye), 06200
- Werving
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
Ankara, Turkije (Türkiye), 06560
- Werving
- Gazi Universitesi Hastanesi
-
Istanbul, Turkije (Türkiye), 34147
- Werving
- Bakirkoy Training and Research Hospital
-
Istanbul, Turkije (Türkiye), 34899
- Werving
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
-
Konya, Turkije (Türkiye), 42090
- Werving
- Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
-
Sakarya, Turkije (Türkiye), 54290
- Werving
- Sakarya University Training and Research Hospital
-
-
-
-
-
Birmingham, Verenigd Koninkrijk, B9 5ST
- Werving
- Birmingham Heartlands Hospital
-
Cambridge, Verenigd Koninkrijk, CB2 0QQ
- Werving
- Addenbrooke's Hospital
-
Edinburgh, Verenigd Koninkrijk, EH4 2XU
- Werving
- Western General Hospital
-
Hull, Verenigd Koninkrijk, HU16 5JQ
- Werving
- Castle Hill Hospital
-
Leeds, Verenigd Koninkrijk, LS9 7TF
- Werving
- St James University Hospital
-
London, Verenigd Koninkrijk, EC1A 7BE
- Werving
- St Bartholomew's Hospital
-
London, Verenigd Koninkrijk, NW1 2BU
- Werving
- University College Hospital
-
Northwood, Verenigd Koninkrijk, HA6 2RN
- Werving
- Mount Vernon Cancer Centre
-
Sutton, Verenigd Koninkrijk, SM2 5PT
- Werving
- Royal Marsden Hospital (Sutton)
-
-
-
-
Arizona
-
Gilbert, Arizona, Verenigde Staten, 85234
- Werving
- Banner MD Anderson Cancer Center
-
-
Arkansas
-
Jonesboro, Arkansas, Verenigde Staten, 72401
- Werving
- St. Bernard's Medical Center
-
Springdale, Arkansas, Verenigde Staten, 72762
- Werving
- Highlands Oncology Group
-
-
California
-
Bakersfield, California, Verenigde Staten, 93309
- Werving
- CBCC Global Research
-
Glendale, California, Verenigde Staten, 91204
- Werving
- Los Angeles Cancer Network
-
Los Alamitos, California, Verenigde Staten, 90720
- Werving
- Cancer and Blood Specialty Clinic
-
Los Angeles, California, Verenigde Staten, 90033
- Werving
- USC Norris Comprehensive Cancer Center
-
Santa Monica, California, Verenigde Staten, 90404
- Werving
- UCLA
-
Santa Rosa, California, Verenigde Staten, 95403
- Werving
- Providence Medical Foundation
-
Torrance, California, Verenigde Staten, 90505
- Werving
- Torrance Memorial Physicians Network
-
-
Colorado
-
Denver, Colorado, Verenigde Staten, 80218
- Werving
- Rocky Mountain Cancer Centers
-
-
Connecticut
-
New Haven, Connecticut, Verenigde Staten, 06519
- Werving
- Yale University School Of Medicine
-
-
District of Columbia
-
Washington D.C., District of Columbia, Verenigde Staten, 20007
- Werving
- Georgetown Univ Medical Center Lombardi Cancer Center
-
-
Florida
-
Fort Myers, Florida, Verenigde Staten, 33901
- Werving
- Florida Cancer Specialists South
-
Orlando, Florida, Verenigde Staten, 32804
- Werving
- AdventHealth Medical Group Oncology and Hematology at Orlando
-
St. Petersburg, Florida, Verenigde Staten, 33701-4553
- Werving
- Florida Cancer Specialists North Region
-
West Palm Beach, Florida, Verenigde Staten, 33401-3406
- Werving
- Florida Cancer Specialists East
-
-
Georgia
-
Atlanta, Georgia, Verenigde Staten, 30303
- Werving
- Grady Memorial Hospital
-
Atlanta, Georgia, Verenigde Staten, 30322
- Werving
- Winship Cancer Institute Emory University
-
-
Illinois
-
Arlington Heights, Illinois, Verenigde Staten, 60005
- Werving
- Illinois Cancer Specialists
-
Peoria, Illinois, Verenigde Staten, 61615
- Werving
- Illinois CancerCare
-
-
Indiana
-
Fort Wayne, Indiana, Verenigde Staten, 46804
- Werving
- Fort Wayne Medical Oncology & Hematology
-
-
Iowa
-
Iowa City, Iowa, Verenigde Staten, 52242
- Werving
- University of Iowa Hospital
-
Waukee, Iowa, Verenigde Staten, 50263
- Werving
- Mission Cancer Blood
-
-
Kansas
-
Wichita, Kansas, Verenigde Staten, 67214
- Werving
- Cancer Center of Kansas
-
-
Louisiana
-
New Orleans, Louisiana, Verenigde Staten, 70121
- Werving
- Ochsner Clinic Foundation
-
-
Maryland
-
Baltimore, Maryland, Verenigde Staten, 21237
- Werving
- MedStar Franklin Square Medical Center
-
Frederick, Maryland, Verenigde Staten, 21702-4337
- Werving
- Frederick Health Hospital - James M Stockman Cancer Institute
-
-
Michigan
-
Ann Arbor, Michigan, Verenigde Staten, 48109
- Werving
- University of Michigan
-
Ann Arbor, Michigan, Verenigde Staten, 48105
- Werving
- VA Ann Arbor Healthcare System
-
Detroit, Michigan, Verenigde Staten, 48202
- Werving
- Henry Ford Hospital
-
Grand Rapids, Michigan, Verenigde Staten, 49503
- Werving
- Cancer And Hematology Centers of Western Michigan PC
-
-
Mississippi
-
Hattiesburg, Mississippi, Verenigde Staten, 39401
- Werving
- Hattiesburg Clinic
-
-
Missouri
-
St Louis, Missouri, Verenigde Staten, 63110
- Werving
- Washington University School Of Medicine
-
-
Nebraska
-
Omaha, Nebraska, Verenigde Staten, 68130
- Werving
- Nebraska Cancer Specialists Midwest Cancer Center
-
-
Nevada
-
Las Vegas, Nevada, Verenigde Staten, 89169
- Werving
- Comprehensive Cancer Centers of Nevada
-
-
New Jersey
-
East Brunswick, New Jersey, Verenigde Staten, 08816
- Werving
- Astera Cancer Care
-
New Brunswick, New Jersey, Verenigde Staten, 08901
- Werving
- Rutgers Cancer Institute
-
-
New Mexico
-
Albuquerque, New Mexico, Verenigde Staten, 87102
- Werving
- University of New Mexico Cancer Center
-
-
New York
-
Mineola, New York, Verenigde Staten, 11501
- Werving
- Perlmutter Cancer Center at NYU Long Island
-
New York, New York, Verenigde Staten, 10003
- Werving
- Mount Sinai
-
New York, New York, Verenigde Staten, 10032
- Werving
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
-
New York, New York, Verenigde Staten, 10016
- Werving
- NYU Langone Medical Center NYU Hematology Associates
-
New York, New York, Verenigde Staten, 10009
- Werving
- Mount Sinai West
-
Shirley, New York, Verenigde Staten, 11967
- Werving
- New York Cancer and Blood Specialists
-
The Bronx, New York, Verenigde Staten, 10461
- Werving
- Montefiore Einstein Comprehensive Cancer Center
-
Williamsville, New York, Verenigde Staten, 14221
- Werving
- University of Buffalo Kaleida Health Cancer Care
-
-
North Carolina
-
Chapel Hill, North Carolina, Verenigde Staten, 27599
- Werving
- University of North Carolina at Chapel Hill
-
-
Ohio
-
Canton, Ohio, Verenigde Staten, 44718
- Werving
- Gabrail Cancer Center
-
Cleveland, Ohio, Verenigde Staten, 44106
- Werving
- University Hospitals Cleveland Medical Center
-
Cleveland, Ohio, Verenigde Staten, 44195
- Werving
- Taussig Cancer Insititute Cleveland Clinic
-
Cleveland, Ohio, Verenigde Staten, 44111
- Werving
- Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
-
Independence, Ohio, Verenigde Staten, 44131
- Werving
- Cleveland Clinic Cancer Center Independence Family Health Center
-
Mansfield, Ohio, Verenigde Staten, 44906
- Werving
- Cleveland Clinic Cancer Center Mansfield
-
Mayfield Heights, Ohio, Verenigde Staten, 44124
- Werving
- Cleveland Clinic Cancer Center Hillcrest Hospital
-
Sandusky, Ohio, Verenigde Staten, 44870
- Werving
- Cleveland Clinic Cancer Centers Sandusky
-
Strongsville, Ohio, Verenigde Staten, 44136
- Werving
- Cleveland Clinic Cancer Center Strongsville
-
Warrensville Heights, Ohio, Verenigde Staten, 44122
- Werving
- Cleveland Clinic Cancer Center South Pointe Hospital
-
Wooster, Ohio, Verenigde Staten, 44691
- Werving
- Wooster Milltown Specialty and Surgery Center
-
-
Oregon
-
Bend, Oregon, Verenigde Staten, 97701
- Werving
- St Charles Medical Center
-
Portland, Oregon, Verenigde Staten, 97239
- Werving
- Oregon Health And Science University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Verenigde Staten, 19111
- Werving
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Werving
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15232 1301
- Werving
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
-
-
Tennessee
-
Nashville, Tennessee, Verenigde Staten, 37203
- Werving
- SCRI Oncology Partners
-
-
Texas
-
Abilene, Texas, Verenigde Staten, 79606
- Werving
- Texas Oncology West Texas
-
Dallas, Texas, Verenigde Staten, 75246
- Werving
- Texas Oncology DFW
-
Dallas, Texas, Verenigde Staten, 75390
- Werving
- UT Southwestern
-
Houston, Texas, Verenigde Staten, 77030
- Werving
- MD Anderson Cancer Center
-
Round Rock, Texas, Verenigde Staten, 78665
- Werving
- Baylor Scott and White Health 1
-
San Antonio, Texas, Verenigde Staten, 78240
- Werving
- Texas Oncology - San Antonio
-
Temple, Texas, Verenigde Staten, 76508
- Werving
- Baylor Scott and White Health
-
-
Virginia
-
Arlington, Virginia, Verenigde Staten, 22201
- Werving
- Virginia Cancer Specialists
-
Fairfax, Virginia, Verenigde Staten, 22031
- Werving
- Inova Schar Cancer Institute Dept of Fairfax Hospital
-
Richmond, Virginia, Verenigde Staten, 23249
- Werving
- Richmond VA Medical Center
-
Richmond, Virginia, Verenigde Staten, 23298
- Werving
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Edmonds, Washington, Verenigde Staten, 98026
- Werving
- Swedish Cancer Institute Edmonds
-
Issaquah, Washington, Verenigde Staten, 98029
- Werving
- Swedish Cancer Institute Issaquah
-
Seattle, Washington, Verenigde Staten, 98104
- Werving
- Swedish Cancer Institute
-
Seattle, Washington, Verenigde Staten, 98109
- Werving
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Madison, Wisconsin, Verenigde Staten, 53705
- Werving
- William S. Middleton Memorial VA
-
-
-
-
-
Daegu, Zuid -Korea, 41404
- Werving
- Kyungpook National University Chilgok Hospital
-
Seoul, Zuid -Korea, 05505
- Werving
- Asan Medical Center
-
Seoul, Zuid -Korea, 03080
- Werving
- Seoul National University Hospital
-
Seoul, Zuid -Korea, 06351
- Werving
- Samsung Medical Center
-
Seoul, Zuid -Korea, 03722
- Werving
- Severance Hospital Yonsei University Health System
-
Seoul, Zuid -Korea, 06591
- Werving
- The Catholic University of Korea Seoul St Marys Hospital
-
-
-
-
-
Gothenburg, Zweden, 413 45
- Voltooid
- Sahlgrenska University Hospital
-
Lund, Zweden, 222 42
- Werving
- Skanes universitetssjukhus
-
Stockholm, Zweden, 171 76
- Werving
- Karolinska Universitetssjukhuset
-
Stockholm, Zweden, 118 83
- Werving
- Sodersjukhuset
-
Uppsala, Zweden, SE 751 85
- Werving
- Uppsala University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
Amivantamab will be administered.
Andere namen:
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Oxaliplatin will be administered as chemotherapy regimen. Irinotecan hydrochloride will be administered as chemotherapy regimen. |
|
Actieve vergelijker: 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. |
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Oxaliplatin will be administered as chemotherapy regimen. Irinotecan hydrochloride will be administered as chemotherapy regimen. Cetuximab will be administered.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Survival (OS)
Tijdsspanne: 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 BICR
Tijdsspanne: 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
|
|
Objective Response Rate (ORR) as Assessed by Investigator
Tijdsspanne: 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
|
|
Progression Free Survival (PFS) as Assessed by Investigator
Tijdsspanne: 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
|
|
Duration of Response (DOR) as Assessed by BICR
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Time to Response (TTR) as Assessed by BICR
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Progression-free Survival After Subsequent Therapy (PFS2)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Curative Resection (R0) Rate
Tijdsspanne: 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
|
|
Number of Participants with Adverse Events (AEs) by Severity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC-QLQ-C29) Score
Tijdsspanne: 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
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Darmziekten
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Intestinale neoplasmata
- Rectale ziekten
- Colon Ziekten
- Colorectale neoplasmata
- Aminozuren, peptiden en eiwitten
- Eiwitten
- Organische chemicaliën
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Heterocyclische verbindingen, 2-ring
- Heterocyclische verbindingen, gefuseerd ring
- Camptothecin
- Alkaloïden
- Enzymen en co -enzymen
- Antilichamen, monoklonaal, gehumaniseerd
- Antilichamen, monoklonaal
- Antilichamen
- Immunoglobulinen
- Immunoproteïnen
- Bloedeiwitten
- Serum -globulines
- Globulines
- Coördinatiecomplexen
- Pyrimidines
- Formyltetrahydrofolates
- Tetrahydrofolaten
- Foliumzuur
- Pterins
- Pteridines
- Uracil
- Pyrimidinonen
- Co -enzymen
- Oxaliplatine
- Irinotecan
- Cetuximab
- Fluorouracil
- Leucovorin
- Levoleucovorine
- Amivantamab
Andere studie-ID-nummers
- 61186372COR3001
- 2024-513852-13-00 (Register-ID: EUCT number)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .