Une étude de l'amivantamab et de mFOLFOX6 ou FOLFIRI par rapport au cétuximab et mFOLFOX6 ou FOLFIRI comme traitement de première intention chez des participants atteints d'un cancer colorectal gauche de type sauvage non résécable ou métastatique KRAS/NRAS et BRAF (OrigAMI-2)
Une étude de phase 3 randomisée et ouverte sur l'amivantamab et mFOLFOX6 ou FOLFIRI par rapport au cétuximab et mFOLFOX6 ou FOLFIRI comme traitement de première intention chez des participants atteints d'un cancer colorectal gauche non résécable ou métastatique de type sauvage KRAS/NRAS et BRAF
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Accès étendu
Contacts et emplacements
Coordonnées de l'étude
- Nom: Study Contact
- Numéro de téléphone: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Lieux d'étude
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Berlin, Allemagne, 13353
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- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
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Dresden, Allemagne, 01307
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- Universitaetsklinikum Carl Gustav Carus TU Dresden
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Essen, Allemagne, 45147
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- Essen University Hospital
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Frankfurt am Main, Allemagne, 60488
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- Krankenhaus NorthWest
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Freiburg im Breisgau, Allemagne, 79110
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- Praxis fur interdisziplinare Onkologie & Hamatologie GbR
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Hamburg, Allemagne, 22763
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- Asklepios Klinik Altona
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Heidelberg, Allemagne, 69120
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- National Center for Tumor Diseases NCT
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Mainz, Allemagne, 55131
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- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Munich, Allemagne, 81377
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- Klinikum der Universitaet Muenchen
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Ulm, Allemagne, 89081
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- Universitatsklinikum Ulm
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Anderlecht, Belgique, 1070
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- Institut Jules Bordet
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Edegem, Belgique, 2650
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- Universitair Ziekenhuis Antwerpen
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Ghent, Belgique, 9000
- Actif, ne recrute pas
- AZ Maria Middelares
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Haine Saint Paul La Louviere, Belgique, 7100
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- Hopital de Jolimont
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Kortrijk, Belgique, 8500
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- Az Groeninge
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Leuven, Belgique, 3000
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- Universitair Ziekenhuis Leuven
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Liège, Belgique, 4000
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- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
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Barretos, Brésil, 14780 070
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- Fundacao Pio XII
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Caxias do Sul, Brésil, 95070 560
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- Fundacao Universidade de Caxias do Sul
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Jaú, Brésil, 17210 080
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- Fundacao Doutor Amaral Carvalho
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Porto Alegre, Brésil, 91350 200
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- Hospital Nossa Senhora da Conceicao S A
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Salvador, Brésil, 40050 410
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- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
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Santa Maria, Brésil, 97015 450
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- Clinica de Hematologia e Oncologia Viver Ltda
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São José do Rio Preto, Brésil, 15090-000
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- Funfarme Sjrp
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São Paulo, Brésil, 01246 000
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- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brésil, 01509 900
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- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brésil, 05651 900
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- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Vitória, Brésil, 29043 260
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- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
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- Arthur J E Child Comprehensive Cancer Centre
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
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- Ottawa Hospital
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Toronto, Ontario, Canada, M5G1X6
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- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H2X 0C1
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- Centre de Recherche du CHUM
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Beijing, Chine, 100191
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- Peking University Third Hospital
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Beijing, Chine, 100142
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- Beijing Cancer Hospital
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Beijing, Chine, 100034
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- Peking University First Hospital
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Beijing, Chine, 100050
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- Beijing Friendship Hospital Capital Medical University
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Changchun, Chine, 130021
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- The First Bethune Hospital of Jilin University
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Changsha, Chine, 410013
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- Hunan Cancer hospital
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Guangzhou, Chine, 510655
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- The Sixth Affiliated Hospital Sun Yat sen University
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Guangzhou, Chine, 519041
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- Guangdong Provincial People's Hospital
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Guangzhou, Chine, 510062
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- Sun Yat Sen University Cancer Center
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Hangzhou, Chine, 310009
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- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Hangzhou, Chine, 310022
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- Zhejiang Cancer Hospital
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Hangzhou, Chine, 310003
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- The First Affiliated Hospital Zhejiang University College of Medicine
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Harbin, Chine, 150081
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- Harbin medical university cancer hospital
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Huizhou, Chine, 516001
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- Huizhou Central People's Hospital
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Nanchang, Chine, 330006
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- The First Affiliated Hospital of NanChang University
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Shanghai, Chine, 200032
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- Fudan University Shanghai Cancer Center
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Shenyang, Chine, 110042
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- Liaoning Cancer Hospital and Institute
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Shenzhen, Chine, 518036
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- Peking University Shenzhen Hospital
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Sichuan, Chine, 610044
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- West China Hospital of Sichuan University
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Taiyuan, Chine, 030001
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- First Hospital of Shanxi Medical University
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Tianjin, Chine, 300060
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- Tianjin Medical University Cancer Institute and Hospital
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Wuhan, Chine, 430079
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- Hubei Cancer Hospital
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Daegu, Corée du Sud, 41404
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- Kyungpook National University Chilgok Hospital
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Seoul, Corée du Sud, 05505
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- Asan Medical Center
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Seoul, Corée du Sud, 03080
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- Seoul National University Hospital
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Seoul, Corée du Sud, 06351
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- Samsung Medical Center
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Seoul, Corée du Sud, 03722
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- Severance Hospital Yonsei University Health System
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Seoul, Corée du Sud, 06591
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- The Catholic University of Korea Seoul St Marys Hospital
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Barcelona, Espagne, 08041
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- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Espagne, 08035
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- Hosp Univ Vall D Hebron
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Madrid, Espagne, 28034
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- Hosp. Univ. Ramon Y Cajal
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Madrid, Espagne, 28041
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- Hosp. Univ. 12 de Octubre
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Madrid, Espagne, 28007
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- Hosp. Gral. Univ. Gregorio Maranon
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Pamplona, Espagne, 31008
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- Clinica Univ. de Navarra
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Seville, Espagne, 41013
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- Hosp. Virgen Del Rocio
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Valencia, Espagne, 46010
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- Hosp. Clinico Univ. de Valencia
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Avignon, France, 84918
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- Institut Sainte Catherine
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Lille, France, 59000
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- Hopital Claude Huriez
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Lyon, France, 69008
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- Hopital Prive Jean Mermoz
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Montpellier, France, 34298
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- Institut du Cancer de Montpellier
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Nantes, France, 44000
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- CHU Nantes
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Paris, France, 75571
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- Hopital Saint Antoine
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Pessac, France, 33604
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- Hopital Haut Leveque
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Poitiers, France, 86000
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- CHU De Poitiers
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Villejuif, France, 94805
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- Gustave Roussy
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Budapest, Hongrie, 1082
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- Semmelweis Egyetem
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Eger, Hongrie, 3300
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- Markhot Ferenc Oktatokorhaz es Rendelointezet
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Pécs, Hongrie, 7624
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- Pecsi Tudomanyegyetem
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Szeged, Hongrie, 6720
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- Szegedi Tudomanyegyetem
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Delhi, Inde, 110085
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- Rajiv Gandhi Cancer Institute and Research Centre
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Kolkata, Inde, 700053
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- B P Poddar Hospital and Medical research Limited
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Mumbai, Inde, 400012
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- Tata Memorial Hospital
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Pune, Inde, 411004
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- Deenanath Mangeshkar Hospital and Research Centre
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Varanasi, Inde, 221005
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- Mahamana Pandit Madan Mohan Malviya Cancer Centre
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Beer Yaakov, Israël, 70300
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- Yitzhak Shamir Medical Center
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Haifa, Israël, 3109601
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- Rambam Medical Center
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Jerusalem, Israël, 9112001
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- Hadassah University Hospita Ein Kerem
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Petah Tikva, Israël, 4941492
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- Rabin Medical Center
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Ramat Gan, Israël, 52621
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- Sheba Medical Center
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Tel Aviv, Israël, 6423906
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- Tel Aviv Sourasky Medical Center
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Tel Aviv, Israël, 69710
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- Assuta MC
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Meldola, Italie, 47014
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- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, Italie, 20133
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- Istituto Dei Tumori Di Milano
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Padova, Italie, 35128
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- Istituto Oncologico Veneto - IRCCS
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Pisa, Italie, 56126
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- Azienda Ospedaliero Universitaria Pisana
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Rozzano, Italie, 20089
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- Istituto Clinico Humanitas
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Chiba, Japon, 260 0801
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- Chiba Cancer Center
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Chūōku, Japon, 104 0045
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- National Cancer Center Hospital
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Kashiwa, Japon, 277 8577
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- National Cancer Center Hospital East
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Nagoya, Japon, 464-8681
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- Aichi Cancer Center
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Osaka, Japon, 541 8567
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- Osaka International Cancer Institute
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Osaka, Japon, 540 0006
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- National Hospital Organization Osaka National Hospital
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Shizuoka, Japon, 411 8777
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- Shizuoka Cancer Center
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Suita, Japon, 565 0871
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- The University of Osaka Hospital
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Tokyo, Japon, 135 8550
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- The Cancer Institute Hospital of JFCR
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Cheras, Malaisie, 56000
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- Hospital Canselor Tuanku Muhriz UKM
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George Town, Malaisie, 10450
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- Hospital Pulau Pinang
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Ipoh, Malaisie, 30450
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- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, Malaisie, 59100
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- University Malaya Medical Centre
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Kuala Lumpur, Malaisie, 50586
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- Hospital Kuala Lumpur
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Kuching, Malaisie, 93586
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- Hospital Umum Sarawak
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Putrajaya, Malaisie, 62250
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- National Cancer Institute
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Amersfoort, Pays-Bas, 3813 TZ
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- Meander Medisch Centrum
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Amsterdam, Pays-Bas, 1066 CX
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- Antoni van Leeuwenhoek
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Nijmegen, Pays-Bas, 6525 GA
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- Radboud University Medical Center
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Rotterdam, Pays-Bas, 3015 GD
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- Erasmus MC
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Tilburg, Pays-Bas, 5022 GC
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- Elisabeth-TweeSteden Ziekenhuis
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Utrecht, Pays-Bas, 3584 CX
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- UMC Utrecht
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Bialystok, Pologne, 15 027
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- Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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Biała Podlaska, Pologne, 21 500
- Complété
- Wojewodzki Szpital Specjalistyczny
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Brzozów, Pologne, 36 200
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- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
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Gdansk, Pologne, 80 214
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- Uniwersyteckie Centrum Kliniczne
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Gliwice, Pologne, 44 100
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- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
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Lodz, Pologne, 93 339
- Complété
- Instytut Centrum Zdrowia Matki Polki
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Olsztyn, Pologne, 10 228
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- Szpital Kliniczny MSWiA z WMCO
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Opole, Pologne, 45 061
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- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
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Warsaw, Pologne, 02 781
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- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Barrio Monacillos, Porto Rico, 00935
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- Pan American Center for Oncology Trials LLC
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Birmingham, Royaume-Uni, B9 5ST
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- Birmingham Heartlands Hospital
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Cambridge, Royaume-Uni, CB2 0QQ
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- Addenbrooke's Hospital
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Edinburgh, Royaume-Uni, EH4 2XU
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- Western General Hospital
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Hull, Royaume-Uni, HU16 5JQ
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- Castle Hill Hospital
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Leeds, Royaume-Uni, LS9 7TF
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- St James University Hospital
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London, Royaume-Uni, EC1A 7BE
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- St Bartholomew's Hospital
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London, Royaume-Uni, NW1 2BU
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- University College Hospital
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Northwood, Royaume-Uni, HA6 2RN
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- Mount Vernon Cancer Centre
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Sutton, Royaume-Uni, SM2 5PT
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- Royal Marsden Hospital (Sutton)
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Gothenburg, Suède, 413 45
- Complété
- Sahlgrenska University Hospital
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Lund, Suède, 222 42
- Recrutement
- Skanes universitetssjukhus
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Stockholm, Suède, 171 76
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- Karolinska Universitetssjukhuset
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Stockholm, Suède, 118 83
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- Sodersjukhuset
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Uppsala, Suède, SE 751 85
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- Uppsala University
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Kaohsiung City, Taïwan, 83301
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- Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung City, Taïwan, 80756
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- Kaohsiung Medical University Chung Ho Memorial Hospital
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Tainan, Taïwan, 704
- Recrutement
- National Cheng Kung University Hospital
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Taipei, Taïwan, 10043
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- National Taiwan University Hospital
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Taoyuan, Taïwan, 333
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- Linkou Chang Gung Memorial Hospital
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Adana, Turquie (Türkiye), 01060
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- Adana City Hospital
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Ankara, Turquie (Türkiye), 06800
- Recrutement
- Ankara Bilkent Sehir Hastanesi
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Ankara, Turquie (Türkiye), 06010
- Recrutement
- Gulhane Egitim ve Arastirma Hastanesi
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Ankara, Turquie (Türkiye), 06200
- Recrutement
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
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Ankara, Turquie (Türkiye), 06560
- Recrutement
- Gazi Universitesi Hastanesi
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Istanbul, Turquie (Türkiye), 34147
- Recrutement
- Bakirkoy Training and Research Hospital
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Istanbul, Turquie (Türkiye), 34899
- Recrutement
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
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Konya, Turquie (Türkiye), 42090
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- Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
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Sakarya, Turquie (Türkiye), 54290
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- Sakarya University Training and Research Hospital
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Arizona
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Gilbert, Arizona, États-Unis, 85234
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- Banner MD Anderson Cancer Center
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Arkansas
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Jonesboro, Arkansas, États-Unis, 72401
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- St. Bernard's Medical Center
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Springdale, Arkansas, États-Unis, 72762
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- Highlands Oncology Group
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California
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Bakersfield, California, États-Unis, 93309
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- CBCC Global Research
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Glendale, California, États-Unis, 91204
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- Los Angeles Cancer Network
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Los Alamitos, California, États-Unis, 90720
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- Cancer and Blood Specialty Clinic
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Los Angeles, California, États-Unis, 90033
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- USC Norris Comprehensive Cancer Center
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Santa Monica, California, États-Unis, 90404
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- UCLA
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Santa Rosa, California, États-Unis, 95403
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- Providence Medical Foundation
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Torrance, California, États-Unis, 90505
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- Torrance Memorial Physicians Network
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Colorado
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Denver, Colorado, États-Unis, 80218
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- Rocky Mountain Cancer Centers
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Connecticut
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New Haven, Connecticut, États-Unis, 06519
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- Yale University School Of Medicine
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20007
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- Georgetown Univ Medical Center Lombardi Cancer Center
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Florida
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Fort Myers, Florida, États-Unis, 33901
- Recrutement
- Florida Cancer Specialists South
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Orlando, Florida, États-Unis, 32804
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- AdventHealth Medical Group Oncology and Hematology at Orlando
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St. Petersburg, Florida, États-Unis, 33701-4553
- Recrutement
- Florida Cancer Specialists North Region
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West Palm Beach, Florida, États-Unis, 33401-3406
- Recrutement
- Florida Cancer Specialists East
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Georgia
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Atlanta, Georgia, États-Unis, 30303
- Recrutement
- Grady Memorial Hospital
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Atlanta, Georgia, États-Unis, 30322
- Recrutement
- Winship Cancer Institute Emory University
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Illinois
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Arlington Heights, Illinois, États-Unis, 60005
- Recrutement
- Illinois Cancer Specialists
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Peoria, Illinois, États-Unis, 61615
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- Illinois CancerCare
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Indiana
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Fort Wayne, Indiana, États-Unis, 46804
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- Fort Wayne Medical Oncology & Hematology
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Iowa
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Iowa City, Iowa, États-Unis, 52242
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- University of Iowa Hospital
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Waukee, Iowa, États-Unis, 50263
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- Mission Cancer Blood
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Kansas
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Wichita, Kansas, États-Unis, 67214
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- Cancer Center of Kansas
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Louisiana
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New Orleans, Louisiana, États-Unis, 70121
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- Ochsner Clinic Foundation
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Maryland
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Baltimore, Maryland, États-Unis, 21237
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- MedStar Franklin Square Medical Center
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Frederick, Maryland, États-Unis, 21702-4337
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- Frederick Health Hospital - James M Stockman Cancer Institute
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
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- University of Michigan
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Ann Arbor, Michigan, États-Unis, 48105
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- VA Ann Arbor Healthcare System
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Detroit, Michigan, États-Unis, 48202
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- Henry Ford Hospital
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Grand Rapids, Michigan, États-Unis, 49503
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- Cancer And Hematology Centers of Western Michigan PC
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Mississippi
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Hattiesburg, Mississippi, États-Unis, 39401
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- Hattiesburg Clinic
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Missouri
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St Louis, Missouri, États-Unis, 63110
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- Washington University School Of Medicine
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Nebraska
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Omaha, Nebraska, États-Unis, 68130
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- Nebraska Cancer Specialists Midwest Cancer Center
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Nevada
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Las Vegas, Nevada, États-Unis, 89169
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- Comprehensive Cancer Centers of Nevada
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New Jersey
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East Brunswick, New Jersey, États-Unis, 08816
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- Astera Cancer Care
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New Brunswick, New Jersey, États-Unis, 08901
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- Rutgers Cancer Institute
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87102
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- University of New Mexico Cancer Center
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New York
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Mineola, New York, États-Unis, 11501
- Recrutement
- Perlmutter Cancer Center at NYU Long Island
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New York, New York, États-Unis, 10003
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- Mount Sinai
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New York, New York, États-Unis, 10032
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- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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New York, New York, États-Unis, 10016
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- NYU Langone Medical Center NYU Hematology Associates
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New York, New York, États-Unis, 10009
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- Mount Sinai West
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Shirley, New York, États-Unis, 11967
- Recrutement
- New York Cancer and Blood Specialists
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The Bronx, New York, États-Unis, 10461
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- Montefiore Einstein Comprehensive Cancer Center
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Williamsville, New York, États-Unis, 14221
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- University of Buffalo Kaleida Health Cancer Care
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
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- University of North Carolina at Chapel Hill
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Ohio
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Canton, Ohio, États-Unis, 44718
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- Gabrail Cancer Center
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Cleveland, Ohio, États-Unis, 44106
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- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, États-Unis, 44195
- Recrutement
- Taussig Cancer Insititute Cleveland Clinic
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Cleveland, Ohio, États-Unis, 44111
- Recrutement
- Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
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Independence, Ohio, États-Unis, 44131
- Recrutement
- Cleveland Clinic Cancer Center Independence Family Health Center
-
Mansfield, Ohio, États-Unis, 44906
- Recrutement
- Cleveland Clinic Cancer Center Mansfield
-
Mayfield Heights, Ohio, États-Unis, 44124
- Recrutement
- Cleveland Clinic Cancer Center Hillcrest Hospital
-
Sandusky, Ohio, États-Unis, 44870
- Recrutement
- Cleveland Clinic Cancer Centers Sandusky
-
Strongsville, Ohio, États-Unis, 44136
- Recrutement
- Cleveland Clinic Cancer Center Strongsville
-
Warrensville Heights, Ohio, États-Unis, 44122
- Recrutement
- Cleveland Clinic Cancer Center South Pointe Hospital
-
Wooster, Ohio, États-Unis, 44691
- Recrutement
- Wooster Milltown Specialty and Surgery Center
-
-
Oregon
-
Bend, Oregon, États-Unis, 97701
- Recrutement
- St Charles Medical Center
-
Portland, Oregon, États-Unis, 97239
- Recrutement
- Oregon Health And Science University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19111
- Recrutement
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, États-Unis, 19107
- Recrutement
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, États-Unis, 15232 1301
- Recrutement
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
-
-
Tennessee
-
Nashville, Tennessee, États-Unis, 37203
- Recrutement
- SCRI Oncology Partners
-
-
Texas
-
Abilene, Texas, États-Unis, 79606
- Recrutement
- Texas Oncology West Texas
-
Dallas, Texas, États-Unis, 75246
- Recrutement
- Texas Oncology DFW
-
Dallas, Texas, États-Unis, 75390
- Recrutement
- UT Southwestern
-
Houston, Texas, États-Unis, 77030
- Recrutement
- MD Anderson Cancer Center
-
Round Rock, Texas, États-Unis, 78665
- Recrutement
- Baylor Scott and White Health 1
-
San Antonio, Texas, États-Unis, 78240
- Recrutement
- Texas Oncology - San Antonio
-
Temple, Texas, États-Unis, 76508
- Recrutement
- Baylor Scott and White Health
-
-
Virginia
-
Arlington, Virginia, États-Unis, 22201
- Recrutement
- Virginia Cancer Specialists
-
Fairfax, Virginia, États-Unis, 22031
- Recrutement
- Inova Schar Cancer Institute Dept of Fairfax Hospital
-
Richmond, Virginia, États-Unis, 23249
- Recrutement
- Richmond VA Medical Center
-
Richmond, Virginia, États-Unis, 23298
- Recrutement
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Edmonds, Washington, États-Unis, 98026
- Recrutement
- Swedish Cancer Institute Edmonds
-
Issaquah, Washington, États-Unis, 98029
- Recrutement
- Swedish Cancer Institute Issaquah
-
Seattle, Washington, États-Unis, 98104
- Recrutement
- Swedish Cancer Institute
-
Seattle, Washington, États-Unis, 98109
- Recrutement
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Madison, Wisconsin, États-Unis, 53705
- Recrutement
- William S. Middleton Memorial VA
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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. |
|
Comparateur actif: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies intestinales
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies gastro-intestinales
- Tumeurs intestinales
- Maladies rectales
- Maladies du côlon
- Tumeurs colorectales
- Acides aminés, peptides et protéines
- Protéines
- Produits chimiques organiques
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Camptothécine
- Alcaloïdes
- Enzymes et coenzymes
- Anticorps, monoclonal, humanisé
- Anticorps, monoclonal
- Anticorps
- Immunoglobulines
- Immunoprotéines
- Protéines sanguines
- Globulines sériques
- Globulines
- Complexes de coordination
- Pyrimidines
- Formyltétrahydrofolate
- Tétrahydrofolat
- Acide folique
- Pterines
- Ptéridines
- Uracile
- Pyrimidinones
- Coenzymes
- Oxaliplatine
- Irinotécan
- Cétuximab
- Fluorouracile
- Leucovorine
- Lévoleucovorine
- amivantamab
Autres numéros d'identification d'étude
- 61186372COR3001
- 2024-513852-13-00 (Identificateur de registre: EUCT number)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .