Studie Amivantamabu a mFOLFOX6 nebo FOLFIRI versus cetuximab a mFOLFOX6 nebo FOLFIRI jako léčba první linie u účastníků s KRAS/NRAS a BRAF divokého typu neresekovatelného nebo metastatického levostranného kolorektálního karcinomu (OrigAMI-2)
Randomizovaná, otevřená studie fáze 3 amivantamab a mFOLFOX6 nebo FOLFIRI versus cetuximab a mFOLFOX6 nebo FOLFIRI jako léčba první linie u účastníků s neresekovatelným nebo metastatickým levostranným kolorektálním karcinomem divokého typu KRAS/NRAS a 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Rozšířený přístup
Kontakty a umístění
Studijní kontakt
- Jméno: Study Contact
- Telefonní číslo: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studijní místa
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Anderlecht, Belgie, 1070
- Nábor
- Institut Jules Bordet
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Edegem, Belgie, 2650
- Nábor
- Universitair Ziekenhuis Antwerpen
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Ghent, Belgie, 9000
- Aktivní, ne nábor
- AZ Maria Middelares
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Haine Saint Paul La Louviere, Belgie, 7100
- Nábor
- Hopital de Jolimont
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Kortrijk, Belgie, 8500
- Nábor
- Az Groeninge
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Leuven, Belgie, 3000
- Nábor
- Universitair Ziekenhuis Leuven
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Liège, Belgie, 4000
- Nábor
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
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Barretos, Brazílie, 14780 070
- Nábor
- Fundacao Pio XII
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Caxias do Sul, Brazílie, 95070 560
- Nábor
- Fundacao Universidade de Caxias do Sul
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Jaú, Brazílie, 17210 080
- Nábor
- Fundacao Doutor Amaral Carvalho
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Porto Alegre, Brazílie, 91350 200
- Nábor
- Hospital Nossa Senhora da Conceicao S A
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Salvador, Brazílie, 40050 410
- Nábor
- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
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Santa Maria, Brazílie, 97015 450
- Nábor
- Clinica de Hematologia e Oncologia Viver Ltda
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São José do Rio Preto, Brazílie, 15090-000
- Nábor
- Funfarme Sjrp
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São Paulo, Brazílie, 01246 000
- Nábor
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brazílie, 01509 900
- Nábor
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brazílie, 05651 900
- Nábor
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Vitória, Brazílie, 29043 260
- Nábor
- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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Avignon, Francie, 84918
- Nábor
- Institut Sainte Catherine
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Lille, Francie, 59000
- Nábor
- Hopital Claude Huriez
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Lyon, Francie, 69008
- Nábor
- Hopital Prive Jean Mermoz
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Montpellier, Francie, 34298
- Nábor
- Institut du Cancer de Montpellier
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Nantes, Francie, 44000
- Nábor
- CHU Nantes
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Paris, Francie, 75571
- Nábor
- Hopital Saint Antoine
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Pessac, Francie, 33604
- Nábor
- Hopital Haut Leveque
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Poitiers, Francie, 86000
- Nábor
- CHU De Poitiers
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Villejuif, Francie, 94805
- Nábor
- Gustave Roussy
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Amersfoort, Holandsko, 3813 TZ
- Nábor
- Meander Medisch Centrum
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Amsterdam, Holandsko, 1066 CX
- Nábor
- Antoni van Leeuwenhoek
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Nijmegen, Holandsko, 6525 GA
- Nábor
- Radboud University Medical Center
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Rotterdam, Holandsko, 3015 GD
- Nábor
- Erasmus MC
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Tilburg, Holandsko, 5022 GC
- Nábor
- Elisabeth-TweeSteden Ziekenhuis
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Utrecht, Holandsko, 3584 CX
- Nábor
- UMC Utrecht
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Delhi, Indie, 110085
- Nábor
- Rajiv Gandhi Cancer Institute and Research Centre
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Kolkata, Indie, 700053
- Nábor
- B P Poddar Hospital and Medical research Limited
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Mumbai, Indie, 400012
- Nábor
- Tata Memorial Hospital
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Pune, Indie, 411004
- Nábor
- Deenanath Mangeshkar Hospital and Research Centre
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Varanasi, Indie, 221005
- Nábor
- Mahamana Pandit Madan Mohan Malviya Cancer Centre
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Meldola, Itálie, 47014
- Nábor
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, Itálie, 20133
- Nábor
- Istituto Dei Tumori Di Milano
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Padova, Itálie, 35128
- Nábor
- Istituto Oncologico Veneto - IRCCS
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Pisa, Itálie, 56126
- Nábor
- Azienda Ospedaliero Universitaria Pisana
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Rozzano, Itálie, 20089
- Nábor
- Istituto Clinico Humanitas
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-
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-
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Beer Yaakov, Izrael, 70300
- Nábor
- Yitzhak Shamir Medical Center
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Haifa, Izrael, 3109601
- Nábor
- Rambam Medical Center
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Jerusalem, Izrael, 9112001
- Nábor
- Hadassah University Hospita Ein Kerem
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Petah Tikva, Izrael, 4941492
- Nábor
- Rabin Medical Center
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Ramat Gan, Izrael, 52621
- Dokončeno
- Sheba Medical Center
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Tel Aviv, Izrael, 6423906
- Nábor
- Tel Aviv Sourasky Medical Center
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Tel Aviv, Izrael, 69710
- Nábor
- Assuta MC
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-
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-
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Chiba, Japonsko, 260 0801
- Nábor
- Chiba Cancer Center
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Chūōku, Japonsko, 104 0045
- Nábor
- National Cancer Center Hospital
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Kashiwa, Japonsko, 277 8577
- Nábor
- National Cancer Center Hospital East
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Nagoya, Japonsko, 464-8681
- Nábor
- Aichi Cancer Center
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Osaka, Japonsko, 541 8567
- Nábor
- Osaka International Cancer Institute
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Osaka, Japonsko, 540 0006
- Nábor
- National Hospital Organization Osaka National Hospital
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Shizuoka, Japonsko, 411 8777
- Nábor
- Shizuoka Cancer Center
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Suita, Japonsko, 565 0871
- Nábor
- The University of Osaka Hospital
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Tokyo, Japonsko, 135 8550
- Nábor
- The Cancer Institute Hospital of JFCR
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Daegu, Jižní Korea, 41404
- Nábor
- Kyungpook National University Chilgok Hospital
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Seoul, Jižní Korea, 05505
- Nábor
- Asan Medical Center
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Seoul, Jižní Korea, 03080
- Nábor
- Seoul National University Hospital
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Seoul, Jižní Korea, 06351
- Nábor
- Samsung Medical Center
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Seoul, Jižní Korea, 03722
- Nábor
- Severance Hospital Yonsei University Health System
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Seoul, Jižní Korea, 06591
- Nábor
- The Catholic University of Korea Seoul St Marys Hospital
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Alberta
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Calgary, Alberta, Kanada, T2N 5G2
- Nábor
- Arthur J E Child Comprehensive Cancer Centre
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Ontario
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Ottawa, Ontario, Kanada, K1H 8L6
- Nábor
- Ottawa Hospital
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Toronto, Ontario, Kanada, M5G1X6
- Nábor
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Kanada, H2X 0C1
- Nábor
- Centre de Recherche du CHUM
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-
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-
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Cheras, Malajsie, 56000
- Nábor
- Hospital Canselor Tuanku Muhriz UKM
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George Town, Malajsie, 10450
- Nábor
- Hospital Pulau Pinang
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Ipoh, Malajsie, 30450
- Nábor
- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, Malajsie, 59100
- Nábor
- University Malaya Medical Centre
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Kuala Lumpur, Malajsie, 50586
- Nábor
- Hospital Kuala Lumpur
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Kuching, Malajsie, 93586
- Nábor
- Hospital Umum Sarawak
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Putrajaya, Malajsie, 62250
- Nábor
- National Cancer Institute
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Budapest, Maďarsko, 1082
- Nábor
- Semmelweis Egyetem
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Eger, Maďarsko, 3300
- Nábor
- Markhot Ferenc Oktatokorhaz es Rendelointezet
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Pécs, Maďarsko, 7624
- Dokončeno
- Pecsi Tudomanyegyetem
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Szeged, Maďarsko, 6720
- Nábor
- Szegedi Tudomanyegyetem
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Berlin, Německo, 13353
- Nábor
- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
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Dresden, Německo, 01307
- Nábor
- Universitaetsklinikum Carl Gustav Carus TU Dresden
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Essen, Německo, 45147
- Nábor
- Essen University Hospital
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Frankfurt am Main, Německo, 60488
- Nábor
- Krankenhaus NorthWest
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Freiburg im Breisgau, Německo, 79110
- Nábor
- Praxis fur interdisziplinare Onkologie & Hamatologie GbR
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Hamburg, Německo, 22763
- Nábor
- Asklepios Klinik Altona
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Heidelberg, Německo, 69120
- Nábor
- National Center for Tumor Diseases NCT
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Mainz, Německo, 55131
- Nábor
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Munich, Německo, 81377
- Nábor
- Klinikum der Universitaet Muenchen
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Ulm, Německo, 89081
- Nábor
- Universitatsklinikum Ulm
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Bialystok, Polsko, 15 027
- Nábor
- Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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Biała Podlaska, Polsko, 21 500
- Dokončeno
- Wojewodzki Szpital Specjalistyczny
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Brzozów, Polsko, 36 200
- Nábor
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
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Gdansk, Polsko, 80 214
- Nábor
- Uniwersyteckie Centrum Kliniczne
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Gliwice, Polsko, 44 100
- Nábor
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
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Lodz, Polsko, 93 339
- Dokončeno
- Instytut Centrum Zdrowia Matki Polki
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Olsztyn, Polsko, 10 228
- Nábor
- Szpital Kliniczny MSWiA z WMCO
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Opole, Polsko, 45 061
- Nábor
- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
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Warsaw, Polsko, 02 781
- Nábor
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Barrio Monacillos, Portoriko, 00935
- Nábor
- Pan American Center for Oncology Trials LLC
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Birmingham, Spojené království, B9 5ST
- Nábor
- Birmingham Heartlands Hospital
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Cambridge, Spojené království, CB2 0QQ
- Nábor
- Addenbrooke's Hospital
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Edinburgh, Spojené království, EH4 2XU
- Nábor
- Western General Hospital
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Hull, Spojené království, HU16 5JQ
- Nábor
- Castle Hill Hospital
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Leeds, Spojené království, LS9 7TF
- Nábor
- St James University Hospital
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London, Spojené království, EC1A 7BE
- Nábor
- St Bartholomew's Hospital
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London, Spojené království, NW1 2BU
- Nábor
- University College Hospital
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Northwood, Spojené království, HA6 2RN
- Nábor
- Mount Vernon Cancer Centre
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Sutton, Spojené království, SM2 5PT
- Nábor
- Royal Marsden Hospital (Sutton)
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Arizona
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Gilbert, Arizona, Spojené státy, 85234
- Nábor
- Banner MD Anderson Cancer Center
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Arkansas
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Jonesboro, Arkansas, Spojené státy, 72401
- Nábor
- St. Bernard's Medical Center
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Springdale, Arkansas, Spojené státy, 72762
- Nábor
- Highlands Oncology Group
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California
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Bakersfield, California, Spojené státy, 93309
- Nábor
- CBCC Global Research
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Glendale, California, Spojené státy, 91204
- Nábor
- Los Angeles Cancer Network
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Los Alamitos, California, Spojené státy, 90720
- Nábor
- Cancer and Blood Specialty Clinic
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Los Angeles, California, Spojené státy, 90033
- Nábor
- USC Norris Comprehensive Cancer Center
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Santa Monica, California, Spojené státy, 90404
- Nábor
- UCLA
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Santa Rosa, California, Spojené státy, 95403
- Nábor
- Providence Medical Foundation
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Torrance, California, Spojené státy, 90505
- Nábor
- Torrance Memorial Physicians Network
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Colorado
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Denver, Colorado, Spojené státy, 80218
- Nábor
- Rocky Mountain Cancer Centers
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Connecticut
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New Haven, Connecticut, Spojené státy, 06519
- Nábor
- Yale University School Of Medicine
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District of Columbia
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Washington D.C., District of Columbia, Spojené státy, 20007
- Nábor
- Georgetown Univ Medical Center Lombardi Cancer Center
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Florida
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Fort Myers, Florida, Spojené státy, 33901
- Nábor
- Florida Cancer Specialists South
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Orlando, Florida, Spojené státy, 32804
- Nábor
- AdventHealth Medical Group Oncology and Hematology at Orlando
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St. Petersburg, Florida, Spojené státy, 33701-4553
- Nábor
- Florida Cancer Specialists North Region
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West Palm Beach, Florida, Spojené státy, 33401-3406
- Nábor
- Florida Cancer Specialists East
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Georgia
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Atlanta, Georgia, Spojené státy, 30303
- Nábor
- Grady Memorial Hospital
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Atlanta, Georgia, Spojené státy, 30322
- Nábor
- Winship Cancer Institute Emory University
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Illinois
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Arlington Heights, Illinois, Spojené státy, 60005
- Nábor
- Illinois Cancer Specialists
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Peoria, Illinois, Spojené státy, 61615
- Nábor
- Illinois CancerCare
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Indiana
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Fort Wayne, Indiana, Spojené státy, 46804
- Nábor
- Fort Wayne Medical Oncology & Hematology
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-
Iowa
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Iowa City, Iowa, Spojené státy, 52242
- Nábor
- University of Iowa Hospital
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Waukee, Iowa, Spojené státy, 50263
- Nábor
- Mission Cancer Blood
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Kansas
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Wichita, Kansas, Spojené státy, 67214
- Nábor
- Cancer Center of Kansas
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Louisiana
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New Orleans, Louisiana, Spojené státy, 70121
- Nábor
- Ochsner Clinic Foundation
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Maryland
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Baltimore, Maryland, Spojené státy, 21237
- Nábor
- MedStar Franklin Square Medical Center
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Frederick, Maryland, Spojené státy, 21702-4337
- Nábor
- Frederick Health Hospital - James M Stockman Cancer Institute
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
- Nábor
- University of Michigan
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Ann Arbor, Michigan, Spojené státy, 48105
- Nábor
- VA Ann Arbor Healthcare System
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Detroit, Michigan, Spojené státy, 48202
- Nábor
- Henry Ford Hospital
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Grand Rapids, Michigan, Spojené státy, 49503
- Nábor
- Cancer And Hematology Centers of Western Michigan PC
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Mississippi
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Hattiesburg, Mississippi, Spojené státy, 39401
- Nábor
- Hattiesburg Clinic
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Missouri
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St Louis, Missouri, Spojené státy, 63110
- Nábor
- Washington University School Of Medicine
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Nebraska
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Omaha, Nebraska, Spojené státy, 68130
- Nábor
- Nebraska Cancer Specialists Midwest Cancer Center
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Nevada
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Las Vegas, Nevada, Spojené státy, 89169
- Nábor
- Comprehensive Cancer Centers of Nevada
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New Jersey
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East Brunswick, New Jersey, Spojené státy, 08816
- Nábor
- Astera Cancer Care
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New Brunswick, New Jersey, Spojené státy, 08901
- Nábor
- Rutgers Cancer Institute
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New Mexico
-
Albuquerque, New Mexico, Spojené státy, 87102
- Nábor
- University of New Mexico Cancer Center
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New York
-
Mineola, New York, Spojené státy, 11501
- Nábor
- Perlmutter Cancer Center at NYU Long Island
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New York, New York, Spojené státy, 10003
- Nábor
- Mount Sinai
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New York, New York, Spojené státy, 10032
- Nábor
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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New York, New York, Spojené státy, 10016
- Nábor
- NYU Langone Medical Center NYU Hematology Associates
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New York, New York, Spojené státy, 10009
- Nábor
- Mount Sinai West
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Shirley, New York, Spojené státy, 11967
- Nábor
- New York Cancer and Blood Specialists
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The Bronx, New York, Spojené státy, 10461
- Nábor
- Montefiore Einstein Comprehensive Cancer Center
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Williamsville, New York, Spojené státy, 14221
- Nábor
- University of Buffalo Kaleida Health Cancer Care
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North Carolina
-
Chapel Hill, North Carolina, Spojené státy, 27599
- Nábor
- University of North Carolina at Chapel Hill
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Ohio
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Canton, Ohio, Spojené státy, 44718
- Nábor
- Gabrail Cancer Center
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Cleveland, Ohio, Spojené státy, 44106
- Nábor
- University Hospitals Cleveland Medical Center
-
Cleveland, Ohio, Spojené státy, 44195
- Nábor
- Taussig Cancer Insititute Cleveland Clinic
-
Cleveland, Ohio, Spojené státy, 44111
- Nábor
- Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
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Independence, Ohio, Spojené státy, 44131
- Nábor
- Cleveland Clinic Cancer Center Independence Family Health Center
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Mansfield, Ohio, Spojené státy, 44906
- Nábor
- Cleveland Clinic Cancer Center Mansfield
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Mayfield Heights, Ohio, Spojené státy, 44124
- Nábor
- Cleveland Clinic Cancer Center Hillcrest Hospital
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Sandusky, Ohio, Spojené státy, 44870
- Nábor
- Cleveland Clinic Cancer Centers Sandusky
-
Strongsville, Ohio, Spojené státy, 44136
- Nábor
- Cleveland Clinic Cancer Center Strongsville
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Warrensville Heights, Ohio, Spojené státy, 44122
- Nábor
- Cleveland Clinic Cancer Center South Pointe Hospital
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Wooster, Ohio, Spojené státy, 44691
- Nábor
- Wooster Milltown Specialty and Surgery Center
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Oregon
-
Bend, Oregon, Spojené státy, 97701
- Nábor
- St Charles Medical Center
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Portland, Oregon, Spojené státy, 97239
- Nábor
- Oregon Health And Science University
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Pennsylvania
-
Philadelphia, Pennsylvania, Spojené státy, 19111
- Nábor
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Spojené státy, 19107
- Nábor
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, Spojené státy, 15232 1301
- Nábor
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
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-
Tennessee
-
Nashville, Tennessee, Spojené státy, 37203
- Nábor
- SCRI Oncology Partners
-
-
Texas
-
Abilene, Texas, Spojené státy, 79606
- Nábor
- Texas Oncology West Texas
-
Dallas, Texas, Spojené státy, 75246
- Nábor
- Texas Oncology DFW
-
Dallas, Texas, Spojené státy, 75390
- Nábor
- UT Southwestern
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Houston, Texas, Spojené státy, 77030
- Nábor
- MD Anderson Cancer Center
-
Round Rock, Texas, Spojené státy, 78665
- Nábor
- Baylor Scott and White Health 1
-
San Antonio, Texas, Spojené státy, 78240
- Nábor
- Texas Oncology - San Antonio
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Temple, Texas, Spojené státy, 76508
- Nábor
- Baylor Scott and White Health
-
-
Virginia
-
Arlington, Virginia, Spojené státy, 22201
- Nábor
- Virginia Cancer Specialists
-
Fairfax, Virginia, Spojené státy, 22031
- Nábor
- Inova Schar Cancer Institute Dept of Fairfax Hospital
-
Richmond, Virginia, Spojené státy, 23249
- Nábor
- Richmond VA Medical Center
-
Richmond, Virginia, Spojené státy, 23298
- Nábor
- VCU Massey Comprehensive Cancer Center
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Washington
-
Edmonds, Washington, Spojené státy, 98026
- Nábor
- Swedish Cancer Institute Edmonds
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Issaquah, Washington, Spojené státy, 98029
- Nábor
- Swedish Cancer Institute Issaquah
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Seattle, Washington, Spojené státy, 98104
- Nábor
- Swedish Cancer Institute
-
Seattle, Washington, Spojené státy, 98109
- Nábor
- Fred Hutchinson Cancer Research Center
-
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Wisconsin
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Madison, Wisconsin, Spojené státy, 53705
- Nábor
- William S. Middleton Memorial VA
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-
-
-
-
Kaohsiung City, Tchaj-wan, 83301
- Nábor
- Kaohsiung Chang Gung Memorial Hospital
-
Kaohsiung City, Tchaj-wan, 80756
- Nábor
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Tainan, Tchaj-wan, 704
- Nábor
- National Cheng Kung University Hospital
-
Taipei, Tchaj-wan, 10043
- Nábor
- National Taiwan University Hospital
-
Taoyuan, Tchaj-wan, 333
- Nábor
- Linkou Chang Gung Memorial Hospital
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-
-
-
-
Adana, Turecko (Türkiye), 01060
- Nábor
- Adana City Hospital
-
Ankara, Turecko (Türkiye), 06800
- Nábor
- Ankara Bilkent Sehir Hastanesi
-
Ankara, Turecko (Türkiye), 06010
- Nábor
- Gulhane Egitim ve Arastirma Hastanesi
-
Ankara, Turecko (Türkiye), 06200
- Nábor
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
Ankara, Turecko (Türkiye), 06560
- Nábor
- Gazi Universitesi Hastanesi
-
Istanbul, Turecko (Türkiye), 34147
- Nábor
- Bakirkoy Training and Research Hospital
-
Istanbul, Turecko (Türkiye), 34899
- Nábor
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
-
Konya, Turecko (Türkiye), 42090
- Nábor
- Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
-
Sakarya, Turecko (Türkiye), 54290
- Nábor
- Sakarya University Training and Research Hospital
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-
-
-
-
Beijing, Čína, 100191
- Nábor
- Peking University Third Hospital
-
Beijing, Čína, 100142
- Nábor
- Beijing Cancer Hospital
-
Beijing, Čína, 100034
- Nábor
- Peking University First Hospital
-
Beijing, Čína, 100050
- Nábor
- Beijing Friendship Hospital Capital Medical University
-
Changchun, Čína, 130021
- Nábor
- The First Bethune Hospital of Jilin University
-
Changsha, Čína, 410013
- Nábor
- Hunan Cancer hospital
-
Guangzhou, Čína, 510655
- Nábor
- The Sixth Affiliated Hospital Sun Yat sen University
-
Guangzhou, Čína, 519041
- Nábor
- Guangdong Provincial People's Hospital
-
Guangzhou, Čína, 510062
- Nábor
- Sun Yat Sen University Cancer Center
-
Hangzhou, Čína, 310009
- Nábor
- The Second Affiliated Hospital of Zhejiang University College of Medicine
-
Hangzhou, Čína, 310022
- Nábor
- Zhejiang Cancer Hospital
-
Hangzhou, Čína, 310003
- Nábor
- The First Affiliated Hospital Zhejiang University College of Medicine
-
Harbin, Čína, 150081
- Nábor
- Harbin medical university cancer hospital
-
Huizhou, Čína, 516001
- Nábor
- Huizhou Central People's Hospital
-
Nanchang, Čína, 330006
- Nábor
- The First Affiliated Hospital of NanChang University
-
Shanghai, Čína, 200032
- Nábor
- Fudan University Shanghai Cancer Center
-
Shenyang, Čína, 110042
- Nábor
- Liaoning Cancer Hospital and Institute
-
Shenzhen, Čína, 518036
- Nábor
- Peking University Shenzhen Hospital
-
Sichuan, Čína, 610044
- Nábor
- West China Hospital of Sichuan University
-
Taiyuan, Čína, 030001
- Nábor
- First Hospital of Shanxi Medical University
-
Tianjin, Čína, 300060
- Nábor
- Tianjin Medical University Cancer Institute and Hospital
-
Wuhan, Čína, 430079
- Nábor
- Hubei Cancer Hospital
-
-
-
-
-
Barcelona, Španělsko, 08041
- Nábor
- Hosp. de La Santa Creu I Sant Pau
-
Barcelona, Španělsko, 08035
- Nábor
- Hosp Univ Vall D Hebron
-
Madrid, Španělsko, 28034
- Nábor
- Hosp. Univ. Ramon Y Cajal
-
Madrid, Španělsko, 28041
- Nábor
- Hosp. Univ. 12 de Octubre
-
Madrid, Španělsko, 28007
- Nábor
- Hosp. Gral. Univ. Gregorio Maranon
-
Pamplona, Španělsko, 31008
- Nábor
- Clinica Univ. de Navarra
-
Seville, Španělsko, 41013
- Nábor
- Hosp. Virgen Del Rocio
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Valencia, Španělsko, 46010
- Nábor
- Hosp. Clinico Univ. de Valencia
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-
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Gothenburg, Švédsko, 413 45
- Dokončeno
- Sahlgrenska University Hospital
-
Lund, Švédsko, 222 42
- Nábor
- Skanes universitetssjukhus
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Stockholm, Švédsko, 171 76
- Nábor
- Karolinska Universitetssjukhuset
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Stockholm, Švédsko, 118 83
- Nábor
- Sodersjukhuset
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Uppsala, Švédsko, SE 751 85
- Nábor
- Uppsala University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
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. |
|
Aktivní komparátor: 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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival (OS)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Novotvary
- Střevní nemoci
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Střevní novotvary
- Rektální onemocnění
- Onemocnění tlustého střeva
- Kolorektální novotvary
- Aminokyseliny, peptidy a proteiny
- Proteiny
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Camptothecin
- Alkaloidy
- Enzymy a koenzymy
- Protilátky, monoklonální, humanizované
- Protilátky, monoklonální
- Protilátky
- Imunoglobuliny
- Imunoproteiny
- Krevní proteiny
- Sérové globuliny
- Globuliny
- Koordinační komplexy
- Pyrimidiny
- Formyltetrahydrofoláty
- Tetrahydrofoláty
- Kyselina listová
- Pteriny
- Pteridiny
- Uracil
- Pyrimidinony
- Koenzymy
- Oxaliplatina
- Irinotekan
- Cetuximab
- Fluorouracil
- Leukovorin
- Levoleukovorin
- Amivantamab
Další identifikační čísla studie
- 61186372COR3001
- 2024-513852-13-00 (Identifikátor registru: EUCT number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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