Studie Amivantamab a FOLFIRI versus cetuximab/Bevacizumab a FOLFIRI u účastníků s divokým typem kolorektálního karcinomu KRAS/NRAS a BRAF, kteří dříve dostávali chemoterapii (OrigAMI-3)
Randomizovaná, otevřená studie fáze 3 amivantamab + FOLFIRI versus cetuximab/bevacizumab + FOLFIRI u účastníků s KRAS/NRAS a BRAF divokého typu recidivujícího, neresekovatelného nebo metastatického kolorektálního karcinomu, kteří podstoupili předchozí chemoterapii
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
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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Concord, Austrálie, 2139
- Dokončeno
- Concord Hospital
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Heidelberg, Austrálie, 3084
- Nábor
- Warringal Private Hospital
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South Woodville, Austrálie, 5011
- Nábor
- Queen Elizabeth Hospital
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St Albans, Austrálie, 3021
- Nábor
- Western Health Sunshine Hospital
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Anderlecht, Belgie, 1070
- Nábor
- Institut Jules Bordet
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Edegem, Belgie, 2650
- Nábor
- UZ Antwerpen
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Ghent, Belgie, 9000
- Dokončeno
- AZ Maria Middelares
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Haine Saint Paul La Louviere, Belgie, 7100
- Nábor
- 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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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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Pessac, Francie, 33604
- Nábor
- Hopital Haut Leveque
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Poitiers, Francie, 86000
- Nábor
- CHU De Poitiers
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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, 5042 AD
- Nábor
- ETZ TweeSteden
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Hong Kong, Hongkong
- Nábor
- Queen Mary Hospital
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Shatin, Hongkong
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- Prince Of Wales Hospital
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Delhi, Indie, 110085
- Nábor
- Rajiv Gandhi Cancer Institute and Research Centre
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Hyderabad, Indie, 500032
- Nábor
- Asian Institute Of Gastroenterology
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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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New Delhi, Indie, 110029
- Nábor
- Safdarjung 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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Vellore, Indie, 632004
- Nábor
- Christian medical
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Catania, Itálie, 95122
- Nábor
- ARNAS Garibaldi P O Nesima
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Florence, Itálie, 50134
- Nábor
- Careggi University Hospital
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Milan, Itálie, 20133
- Nábor
- Istituto Dei Tumori Di Milano
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Novara, Itálie, 28100
- Nábor
- Fondazione del Piemonte per I Oncologia IRCC Candiolo
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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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Udine, Itálie, 33100
- Dokončeno
- Azienda Sanitaria Universitaria Friuli Centrale ASU FC
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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 Medical Center
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Petah Tikva, Izrael, 4941492
- Nábor
- Rabin Medical Center
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Ramat Gan, Izrael, 52621
- Nábor
- 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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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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Sakai, Japonsko, 590 0197
- Nábor
- Kindai University 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, 02841
- Nábor
- Korea University Anam Hospital
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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 Mary s Hospital
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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
- Institut Kanser Negara Clinical Research Center
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Eger, Maďarsko, 3300
- Dokončeno
- Markhot Ferenc Oktatokorhaz es Rendelointezet
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Pécs, Maďarsko, 7624
- Dokončeno
- Pecsi Tudomanyegyetem
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Szeged, Maďarsko, 6720
- Dokončeno
- Szegedi Tudomanyegyetem
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Chihuahua City, Mexiko, 31217
- Nábor
- Centro Oncologico de Chihuahua
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Guadalajara, Mexiko, 44680
- Nábor
- Actualidad Basada En La Investigacion Del Cancer
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Mexico City, Mexiko, 14080
- Nábor
- Instituto Nacional de Cancerologia
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Mexico City, Mexiko, 06760
- Nábor
- Centro Oncologico Personalizado Cope S De R L De C V
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Monterrey, Mexiko, 64460
- Nábor
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Puebla City, Mexiko, 72530
- Nábor
- Oncocenter
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Querétaro, Mexiko, 76000
- Nábor
- Cuidados Oncologicos
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Querétaro, Mexiko, 76230
- Nábor
- Health Pharma Queretaro SA de CV
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Tijuana, Mexiko, 22010
- Nábor
- COI Centro Oncologico Internacional Tijuana
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Berlin, Německo, 13353
- Nábor
- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
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Frankfurt am Main, Německo, 60488
- Nábor
- Krankenhaus NorthWest
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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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Bialystok, Polsko, 15 027
- Dokončeno
- 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
- Dokončeno
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
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Lodz, Polsko, 93 339
- Nábor
- Instytut Centrum Zdrowia Matki Polki
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Olsztyn, Polsko, 10 228
- Dokončeno
- 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, 02 034
- Nábor
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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San Juan, Portoriko, 00935
- Nábor
- Pan American Center for Oncology Trials LLC
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Brasov, Rumunsko, 500091
- Nábor
- Centrul Medical Unirea SRL
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Bucharest, Rumunsko, 013812
- Nábor
- Spitalul Memorial Baneasa
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Bucharest, Rumunsko, 014142
- Dokončeno
- Ponderas Academic Hospital
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Bucharest, Rumunsko, 077190
- Dokončeno
- Neolife Medical Center Bucharest
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Cluj-Napoca, Rumunsko, 400015
- Nábor
- Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca
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Craiova, Rumunsko, 200542
- Nábor
- Clinica de Oncologie Sf Nectarie
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Iași, Rumunsko, 700483
- Nábor
- Institutul Regional de Oncologie Iasi
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Oradea, Rumunsko, 410469
- Nábor
- Pelican Impex SRL
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Birmingham, Spojené království, B9 5ST
- Nábor
- Birmingham Heartlands 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, SW3 6JJ
- Nábor
- Royal Marsden 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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Arizona
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Chandler, Arizona, Spojené státy, 85224
- Nábor
- Ironwood Cancer and Research Center
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Gilbert, Arizona, Spojené státy, 85234
- Nábor
- Banner MD Anderson Cancer Center
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Prescott, Arizona, Spojené státy, 86301
- Dokončeno
- Arizona Oncology Associates PC NAHOA
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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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Aurora, Colorado, Spojené státy, 80045
- Nábor
- University of Colorado Denver Anschultz Medical Campus
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Denver, Colorado, Spojené státy, 80218
- Nábor
- Rocky Mountain Cancer Centers
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Connecticut
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Norwich, Connecticut, Spojené státy, 06360
- Dokončeno
- Eastern Connecticut Hematology & Oncology Assoc.
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Florida
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Fort Myers, Florida, Spojené státy, 33901
- Nábor
- Florida Cancer Specialists South
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Miami Beach, Florida, Spojené státy, 33140
- Dokončeno
- Mount Sinai Medical Center Campus
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Orlando, Florida, Spojené státy, 32804
- Nábor
- AdventHealth Cancer Institute
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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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Athens, Georgia, Spojené státy, 30607
- Nábor
- University Cancer And Blood Center LLC
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Atlanta, Georgia, Spojené státy, 30303
- Nábor
- Grady Memorial Hospital
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Atlanta, Georgia, Spojené státy, 30318
- Nábor
- Piedmont Cancer Institute
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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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Indianapolis, Indiana, Spojené státy, 46237
- Nábor
- Franciscan Health
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Iowa
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Iowa City, Iowa, Spojené státy, 52242
- Nábor
- University of Iowa Hospitals and Clinics
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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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Baton Rouge, Louisiana, Spojené státy, 70809
- Nábor
- Mary Bird Perkins Cancer Center
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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
- 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 Rogel Cancer Center
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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
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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 York
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Mineola, New York, Spojené státy, 11501
- Nábor
- Perlmutter Cancer Center at NYU Long Island
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New York, New York, Spojené státy, 10016
- Nábor
- NYU Langone Medical Center NYU Hematology Associates
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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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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 Hospital of Cleveland
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Oregon
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Portland, Oregon, Spojené státy, 97239
- Nábor
- Oregon Health And Science University
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Pennsylvania
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Penn Wynne, Pennsylvania, Spojené státy, 19096
- Nábor
- Alliance Cancer Specialists at Main Line
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Philadelphia, Pennsylvania, Spojené státy, 19111
- Nábor
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Spojené státy, 19107
- Nábor
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Spojené státy, 15232 1301
- Nábor
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37404
- Nábor
- Tennessee Oncology Chattanooga
-
Nashville, Tennessee, Spojené státy, 37232
- Nábor
- Vanderbilt University Medical Center
-
Nashville, Tennessee, Spojené státy, 37203
- Nábor
- Tennessee Oncology
-
Nashville, Tennessee, Spojené státy, 37203
- Nábor
- SCRI Oncology Partners
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-
Texas
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Abilene, Texas, Spojené státy, 79606
- Nábor
- Texas Oncology West Texas
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Dallas, Texas, Spojené státy, 75390
- Nábor
- UT Southwestern Medical Center
-
Dallas, Texas, Spojené státy, 75235
- Nábor
- Parkland Health and Hospital System
-
Dallas, Texas, Spojené státy, 75246
- Nábor
- Texas Oncology DFW
-
Houston, Texas, Spojené státy, 77030
- Nábor
- MD Anderson Cancer Center
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Round Rock, Texas, Spojené státy, 77845
- Nábor
- Baylor Scott & White Medical Center
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San Antonio, Texas, Spojené státy, 78240
- Nábor
- Texas Oncology - San Antonio
-
Temple, Texas, Spojené státy, 76508
- Nábor
- Scott And White Memorial Hospital
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Tyler, Texas, Spojené státy, 75701
- Nábor
- UT Health East Texas HOPE Cancer Center
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-
Virginia
-
Arlington, Virginia, Spojené státy, 22201
- Nábor
- Virginia Cancer Specialists
-
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
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Lacey, Washington, Spojené státy, 98503
- Nábor
- Providence Regional Cancer System
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Seattle, Washington, Spojené státy, 98109
- Nábor
- Fred Hutchinson Cancer Research Center
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Wisconsin
-
Milwaukee, Wisconsin, Spojené státy, 53226
- Nábor
- Medical College Of Wisconsin
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-
-
-
-
Kaohsiung City, Tchaj-wan, 833
- Nábor
- Chang Gung Memorial Hospital
-
Kaohsiung City, Tchaj-wan, 80756
- Nábor
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Taichung, Tchaj-wan, 40705
- Nábor
- Taichung Veterans General Hospital
-
Tainan, Tchaj-wan, 704
- Nábor
- National Cheng Kung University Hospital
-
Taipei, Tchaj-wan, 112
- Nábor
- Taipei Veterans General Hospital
-
Taipei, Tchaj-wan, 10043
- Nábor
- National Taiwan University Hospital
-
Taoyuan, Tchaj-wan, 333
- Nábor
- Linkou Chang Gung Memorial Hospital
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-
-
-
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Bangkok, Thajsko, 10700
- Nábor
- Siriraj Hospital
-
Bangkok, Thajsko, 10400
- Nábor
- Ramathibodi Hospital
-
Chiang Mai, Thajsko, 50200
- Nábor
- Chiang Mai University
-
Songkhla, Thajsko, 90110
- Nábor
- Songklanagarind 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
-
Antalya, Turecko (Türkiye), 07025
- Nábor
- Memorial Antalya Hospital
-
Edirne, Turecko (Türkiye), 22030
- Nábor
- Trakya University Medical Faculty
-
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
-
-
-
-
-
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
-
Chengdu, Čína, 610041
- Nábor
- West China Hospital of Sichuan University
-
Ganzhou, Čína, 341000
- Nábor
- Ganzhou 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, 100142
- Nábor
- Sun Yat Sen University Cancer Center
-
Hangzhou, Čína, 310022
- Nábor
- Zhejiang Cancer Hospital
-
Hangzhou, Čína, 310009
- Nábor
- The Second Affiliated Hospital of Zhejiang University
-
Harbin, Čína, 150081
- Nábor
- Harbin medical university cancer hospital
-
Huizhou, Čína, 516001
- Nábor
- Huizhou Central People's Hospital
-
Lanzhou, Čína, 730050
- Nábor
- Gansu Provincial Cancer 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
-
Tianjin, Čína, 300060
- Nábor
- Tianjin Medical University Cancer Institute and Hospital
-
Wuhan, Čína, 430079
- Nábor
- Hubei Cancer Hospital
-
-
-
-
-
Badajoz, Španělsko, 06006
- Nábor
- Hosp. Univ. de Badajoz
-
Barcelona, Španělsko, 08028
- Nábor
- Hosp. Univ. Quiron Dexeus
-
Barcelona, Španělsko, 08003
- Nábor
- Hosp. Del Mar
-
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
-
Madrid, Španělsko, 28040
- Nábor
- Hosp Univ Fund Jimenez Diaz
-
Madrid, Španělsko, 28002
- Nábor
- Hosp San Francisco de Asis
-
Málaga, Španělsko, 29010
- Nábor
- Hosp Regional Univ de Malaga
-
Pamplona, Španělsko, 31008
- Nábor
- Clinica Univ. de Navarra
-
Seville, Španělsko, 41013
- Nábor
- Hosp. Virgen Del Rocio
-
Valencia, Španělsko, 46010
- Nábor
- Hosp. Clinico Univ. de Valencia
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Gothenburg, Švédsko, 413 45
- Dokončeno
- Sahlgrenska Universitetssjukhuset
-
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 colon or rectum. Participants must have recurrent, unresectable or metastatic disease
- Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing
- Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible
- Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
- Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
- Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy
Exclusion Criteria:
- Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
- Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI
- Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is 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 who has not received immunotherapy treatments
- Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
- Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)
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 + FOLFIRI
Participants will receive amivantamab along with FOLFIRI (consisting of 5-fluorouracil, leucovorin calcium [folinic acid] or levoleucovorin, and irinotecan) as a chemotherapy regimen 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.
Ostatní jména:
Irinotecan will be administered as chemotherapy regimen. |
|
Aktivní komparátor: Arm B: Cetuximab or Bevacizumab + FOLFIRI
Participants will receive either cetuximab or bevacizumab along with FOLFIRI as a chemotherapy regimen 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.
Ostatní jména:
Cetuximab will be administered.
Ostatní jména:
Irinotecan will be administered as chemotherapy regimen. Bevacizumab 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 2 years 1 month
|
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 2 years 1 month
|
|
Overall Survival (OS)
Časové okno: Up to 4 years 4 months
|
OS is defined as the time from the date of randomization to the date of participant's death due to any cause. |
Up to 4 years 4 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by BICR
Časové okno: Up to 4 years 4 months
|
ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria. |
Up to 4 years 4 months
|
|
ORR as Assessed by Investigator
Časové okno: Up to 4 years 4 months
|
ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by investigator using RECIST v1.1 criteria. |
Up to 4 years 4 months
|
|
Progression Free Survival as Assessed by Investigator
Časové okno: Up to 4 years 4 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 investigator. |
Up to 4 years 4 months
|
|
Duration of Response (DoR) as Assessed by BICR
Časové okno: Up to 4 years 4 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. |
Up to 4 years 4 months
|
|
Duration of Response as Assessed by Investigator
Časové okno: Up to 4 years 4 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 investigator. |
Up to 4 years 4 months
|
|
Time to Response (TTR) as Assessed by BICR
Časové okno: Up to 4 years 4 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 4 years 4 months
|
|
TTR as Assessed by Investigator
Časové okno: Up to 4 years 4 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 4 years 4 months
|
|
Progression Free Survival After Subsequent Therapy (PFS2)
Časové okno: Up to 4 years 4 months
|
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent systemic anticancer therapy, based on investigator assessment or death, whichever comes first. |
Up to 4 years 4 months
|
|
Disease Control Rate (DCR) as Assessed by BICR
Časové okno: Up to 4 years 4 months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as defined by BICR using RECIST v1.1. |
Up to 4 years 4 months
|
|
Disease Control Rate as Assessed by Investigator
Časové okno: Up to 4 years 4 months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as assessed by investigator. |
Up to 4 years 4 months
|
|
Time to Treatment Failure
Časové okno: Up to 4 years 4 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 4 years 4 months
|
|
Curative Resection (R0) Rate
Časové okno: Up to 4 years 4 months
|
Curative resection (R0) rate is defined as the percentage of randomized participants who underwent curative-intent surgery where the residual tumor classification was R0. |
Up to 4 years 4 months
|
|
Number of Participants with Adverse Events (AEs) by Severity
Časové okno: Up to 4 years 4 months
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe 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 4 years 4 months
|
|
Number of Participants with Abnormalities in Laboratory Values
Časové okno: Up to 4 years 4 months
|
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported. |
Up to 4 years 4 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 4 years 4 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 4 years 4 months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
Časové okno: Up to 4 years 4 months
|
Time to worsening in symptoms and functioning as measured by EORTC QLQ-C30 score will be reported. 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. |
Up to 4 years 4 months
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29) Score
Časové okno: From baseline up to 4 years 4 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 4 years 4 months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29 Score
Časové okno: Up to 4 years 4 months
|
Time to worsening in symptoms and functioning as measured by EORTC QLQ-CR29 will be reported. 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. Change from baseline in the EORTC QLQ-CR29 score will be reported. |
Up to 4 years 4 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 4 years 4 months
|
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 indicates severe symptoms. |
Up to 4 years 4 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
- 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
- Pyrimidiny
- Formyltetrahydrofoláty
- Tetrahydrofoláty
- Kyselina listová
- Pteriny
- Pteridiny
- Uracil
- Pyrimidinony
- Koenzymy
- Bevacizumab
- Irinotekan
- Cetuximab
- Fluorouracil
- Leukovorin
- Levoleukovorin
- Amivantamab
Další identifikační čísla studie
- 61186372COR3002
- 2024-513853-66-00 (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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