Uno studio di Amivantamab e FOLFIRI rispetto a Cetuximab/Bevacizumab e FOLFIRI in partecipanti con cancro del colon-retto di tipo selvaggio KRAS/NRAS e BRAF che hanno precedentemente ricevuto chemioterapia (OrigAMI-3)
Uno studio randomizzato, in aperto di Fase 3 di Amivantamab + FOLFIRI rispetto a Cetuximab/Bevacizumab + FOLFIRI in partecipanti con cancro colorettale ricorrente, non resecabile o metastatico KRAS/NRAS e BRAF wild-type che hanno ricevuto una precedente chemioterapia
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Accesso esteso
Contatti e Sedi
Contatto studio
- Nome: Study Contact
- Numero di telefono: 844-434-4210
- Email: Participate-In-This-Study1@its.jnj.com
Luoghi di studio
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Concord, Australia, 2139
- Completato
- Concord Hospital
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Heidelberg, Australia, 3084
- Reclutamento
- Warringal Private Hospital
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South Woodville, Australia, 5011
- Reclutamento
- Queen Elizabeth Hospital
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St Albans, Australia, 3021
- Reclutamento
- Western Health Sunshine Hospital
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Anderlecht, Belgio, 1070
- Reclutamento
- Institut Jules Bordet
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Edegem, Belgio, 2650
- Reclutamento
- UZ Antwerpen
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Ghent, Belgio, 9000
- Completato
- AZ Maria Middelares
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Haine Saint Paul La Louviere, Belgio, 7100
- Reclutamento
- Jolimont
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Kortrijk, Belgio, 8500
- Reclutamento
- Az Groeninge
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Leuven, Belgio, 3000
- Reclutamento
- Universitair Ziekenhuis Leuven
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Liège, Belgio, 4000
- Reclutamento
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
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Barretos, Brasile, 14780 070
- Reclutamento
- Fundacao Pio XII
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Caxias do Sul, Brasile, 95070 560
- Reclutamento
- Fundacao Universidade de Caxias do Sul
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Jaú, Brasile, 17210 080
- Reclutamento
- Fundacao Doutor Amaral Carvalho
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Porto Alegre, Brasile, 91350 200
- Reclutamento
- Hospital Nossa Senhora da Conceicao S A
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Salvador, Brasile, 40050 410
- Reclutamento
- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
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São José do Rio Preto, Brasile, 15090-000
- Reclutamento
- Funfarme Sjrp
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São Paulo, Brasile, 01246 000
- Reclutamento
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brasile, 01509 900
- Reclutamento
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasile, 05651 900
- Reclutamento
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Vitória, Brasile, 29043 260
- Reclutamento
- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
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Beijing, Cina, 100142
- Reclutamento
- Beijing Cancer Hospital
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Beijing, Cina, 100034
- Reclutamento
- Peking University First Hospital
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Beijing, Cina, 100050
- Reclutamento
- Beijing Friendship Hospital Capital Medical University
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Changchun, Cina, 130021
- Reclutamento
- The First Bethune Hospital of Jilin University
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Changsha, Cina, 410013
- Reclutamento
- Hunan Cancer hospital
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Chengdu, Cina, 610041
- Reclutamento
- West China Hospital of Sichuan University
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Ganzhou, Cina, 341000
- Reclutamento
- Ganzhou Cancer Hospital
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Guangzhou, Cina, 510655
- Reclutamento
- The Sixth Affiliated Hospital Sun Yat sen University
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Guangzhou, Cina, 519041
- Reclutamento
- Guangdong Provincial People's Hospital
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Guangzhou, Cina, 100142
- Reclutamento
- Sun Yat Sen University Cancer Center
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Hangzhou, Cina, 310022
- Reclutamento
- Zhejiang Cancer Hospital
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Hangzhou, Cina, 310009
- Reclutamento
- The Second Affiliated Hospital of Zhejiang University
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Harbin, Cina, 150081
- Reclutamento
- Harbin medical university cancer hospital
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Huizhou, Cina, 516001
- Reclutamento
- Huizhou Central People's Hospital
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Lanzhou, Cina, 730050
- Reclutamento
- Gansu Provincial Cancer Hospital
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Nanchang, Cina, 330006
- Reclutamento
- The First Affiliated Hospital of NanChang University
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Shanghai, Cina, 200032
- Reclutamento
- Fudan University Shanghai Cancer Center
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Shenyang, Cina, 110042
- Reclutamento
- Liaoning Cancer Hospital and Institute
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Tianjin, Cina, 300060
- Reclutamento
- Tianjin Medical University Cancer Institute and Hospital
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Wuhan, Cina, 430079
- Reclutamento
- Hubei Cancer Hospital
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Daegu, Corea del Sud, 41404
- Reclutamento
- Kyungpook National University Chilgok Hospital
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Seoul, Corea del Sud, 05505
- Reclutamento
- Asan Medical Center
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Seoul, Corea del Sud, 03080
- Reclutamento
- Seoul National University Hospital
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Seoul, Corea del Sud, 06351
- Reclutamento
- Samsung Medical Center
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Seoul, Corea del Sud, 02841
- Reclutamento
- Korea University Anam Hospital
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Seoul, Corea del Sud, 03722
- Reclutamento
- Severance Hospital Yonsei University Health System
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Seoul, Corea del Sud, 06591
- Reclutamento
- The Catholic University of Korea Seoul St Mary s Hospital
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Avignon, Francia, 84918
- Reclutamento
- Institut Sainte Catherine
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Pessac, Francia, 33604
- Reclutamento
- Hopital Haut Leveque
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Poitiers, Francia, 86000
- Reclutamento
- CHU De Poitiers
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Berlin, Germania, 13353
- Reclutamento
- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
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Frankfurt am Main, Germania, 60488
- Reclutamento
- Krankenhaus NorthWest
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Heidelberg, Germania, 69120
- Reclutamento
- National Center for Tumor Diseases NCT
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Mainz, Germania, 55131
- Reclutamento
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Munich, Germania, 81377
- Reclutamento
- Klinikum der Universitaet Muenchen
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Chiba, Giappone, 260 0801
- Reclutamento
- Chiba Cancer Center
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Chūōku, Giappone, 104 0045
- Reclutamento
- National Cancer Center Hospital
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Kashiwa, Giappone, 277 8577
- Reclutamento
- National Cancer Center Hospital East
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Nagoya, Giappone, 464-8681
- Reclutamento
- Aichi Cancer Center
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Osaka, Giappone, 541 8567
- Reclutamento
- Osaka International Cancer Institute
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Osaka, Giappone, 540 0006
- Reclutamento
- National Hospital Organization Osaka National Hospital
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Sakai, Giappone, 590 0197
- Reclutamento
- Kindai University Hospital
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Shizuoka, Giappone, 411 8777
- Reclutamento
- Shizuoka Cancer Center
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Suita, Giappone, 565 0871
- Reclutamento
- The University of Osaka Hospital
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Tokyo, Giappone, 135 8550
- Reclutamento
- The Cancer Institute Hospital of JFCR
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Hong Kong, Hong Kong
- Reclutamento
- Queen Mary Hospital
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Shatin, Hong Kong
- Reclutamento
- Prince Of Wales Hospital
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Delhi, India, 110085
- Reclutamento
- Rajiv Gandhi Cancer Institute and Research Centre
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Hyderabad, India, 500032
- Reclutamento
- Asian Institute Of Gastroenterology
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Kolkata, India, 700053
- Reclutamento
- B P Poddar Hospital and Medical research Limited
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Mumbai, India, 400012
- Reclutamento
- Tata Memorial Hospital
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New Delhi, India, 110029
- Reclutamento
- Safdarjung Hospital
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Pune, India, 411004
- Reclutamento
- Deenanath Mangeshkar Hospital and Research Centre
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Varanasi, India, 221005
- Reclutamento
- Mahamana Pandit Madan Mohan Malviya Cancer Centre
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Vellore, India, 632004
- Reclutamento
- Christian medical
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Beer Yaakov, Israele, 70300
- Reclutamento
- Yitzhak Shamir Medical Center
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Haifa, Israele, 3109601
- Reclutamento
- Rambam Medical Center
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Jerusalem, Israele, 9112001
- Reclutamento
- Hadassah Medical Center
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Petah Tikva, Israele, 4941492
- Reclutamento
- Rabin Medical Center
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Ramat Gan, Israele, 52621
- Reclutamento
- Sheba Medical Center
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Tel Aviv, Israele, 6423906
- Reclutamento
- Tel Aviv Sourasky Medical Center
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Tel Aviv, Israele, 69710
- Reclutamento
- Assuta MC
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Catania, Italia, 95122
- Reclutamento
- ARNAS Garibaldi P O Nesima
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Florence, Italia, 50134
- Reclutamento
- Careggi University Hospital
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Milan, Italia, 20133
- Reclutamento
- Istituto Dei Tumori Di Milano
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Novara, Italia, 28100
- Reclutamento
- Fondazione del Piemonte per I Oncologia IRCC Candiolo
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Padova, Italia, 35128
- Reclutamento
- Istituto Oncologico Veneto - IRCCS
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Pisa, Italia, 56126
- Reclutamento
- Azienda Ospedaliero Universitaria Pisana
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Rozzano, Italia, 20089
- Reclutamento
- Istituto Clinico Humanitas
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Udine, Italia, 33100
- Completato
- Azienda Sanitaria Universitaria Friuli Centrale ASU FC
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George Town, Malaysia, 10450
- Reclutamento
- Hospital Pulau Pinang
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Ipoh, Malaysia, 30450
- Reclutamento
- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, Malaysia, 59100
- Reclutamento
- University Malaya Medical Centre
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Kuala Lumpur, Malaysia, 50586
- Reclutamento
- Hospital Kuala Lumpur
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Kuching, Malaysia, 93586
- Reclutamento
- Hospital Umum Sarawak
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Putrajaya, Malaysia, 62250
- Reclutamento
- Institut Kanser Negara Clinical Research Center
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Chihuahua City, Messico, 31217
- Reclutamento
- Centro Oncologico de Chihuahua
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Guadalajara, Messico, 44680
- Reclutamento
- Actualidad Basada En La Investigacion Del Cancer
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Mexico City, Messico, 14080
- Reclutamento
- Instituto Nacional de Cancerologia
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Mexico City, Messico, 06760
- Reclutamento
- Centro Oncologico Personalizado Cope S De R L De C V
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Monterrey, Messico, 64460
- Reclutamento
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Puebla City, Messico, 72530
- Reclutamento
- Oncocenter
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Querétaro, Messico, 76000
- Reclutamento
- Cuidados Oncologicos
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Querétaro, Messico, 76230
- Reclutamento
- Health Pharma Queretaro SA de CV
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Tijuana, Messico, 22010
- Reclutamento
- COI Centro Oncologico Internacional Tijuana
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Amersfoort, Olanda, 3813 TZ
- Reclutamento
- Meander Medisch Centrum
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Amsterdam, Olanda, 1066 CX
- Reclutamento
- Antoni van Leeuwenhoek
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Nijmegen, Olanda, 6525 GA
- Reclutamento
- Radboud University Medical Center
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Rotterdam, Olanda, 3015 GD
- Reclutamento
- Erasmus MC
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Tilburg, Olanda, 5042 AD
- Reclutamento
- ETZ TweeSteden
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Bialystok, Polonia, 15 027
- Completato
- Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
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Biała Podlaska, Polonia, 21 500
- Completato
- Wojewodzki Szpital Specjalistyczny
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Brzozów, Polonia, 36 200
- Reclutamento
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
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Gdansk, Polonia, 80 214
- Reclutamento
- Uniwersyteckie Centrum Kliniczne
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Gliwice, Polonia, 44 100
- Completato
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
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Lodz, Polonia, 93 339
- Reclutamento
- Instytut Centrum Zdrowia Matki Polki
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Olsztyn, Polonia, 10 228
- Completato
- Szpital Kliniczny MSWiA z WMCO
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Opole, Polonia, 45 061
- Reclutamento
- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
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Warsaw, Polonia, 02 034
- Reclutamento
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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San Juan, Porto Rico, 00935
- Reclutamento
- Pan American Center for Oncology Trials LLC
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Birmingham, Regno Unito, B9 5ST
- Reclutamento
- Birmingham Heartlands Hospital
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Hull, Regno Unito, HU16 5JQ
- Reclutamento
- Castle Hill Hospital
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Leeds, Regno Unito, LS9 7TF
- Reclutamento
- St James University Hospital
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London, Regno Unito, EC1A 7BE
- Reclutamento
- St Bartholomew's Hospital
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London, Regno Unito, SW3 6JJ
- Reclutamento
- Royal Marsden Hospital
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London, Regno Unito, NW1 2BU
- Reclutamento
- University College Hospital
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Northwood, Regno Unito, HA6 2RN
- Reclutamento
- Mount Vernon Cancer Centre
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Brasov, Romania, 500091
- Reclutamento
- Centrul Medical Unirea SRL
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Bucharest, Romania, 013812
- Reclutamento
- Spitalul Memorial Baneasa
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Bucharest, Romania, 014142
- Completato
- Ponderas Academic Hospital
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Bucharest, Romania, 077190
- Completato
- Neolife Medical Center Bucharest
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Cluj-Napoca, Romania, 400015
- Reclutamento
- Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca
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Craiova, Romania, 200542
- Reclutamento
- Clinica de Oncologie Sf Nectarie
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Iași, Romania, 700483
- Reclutamento
- Institutul Regional de Oncologie Iasi
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Oradea, Romania, 410469
- Reclutamento
- Pelican Impex SRL
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-
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-
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Badajoz, Spagna, 06006
- Reclutamento
- Hosp. Univ. de Badajoz
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Barcelona, Spagna, 08028
- Reclutamento
- Hosp. Univ. Quiron Dexeus
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Barcelona, Spagna, 08003
- Reclutamento
- Hosp. Del Mar
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Barcelona, Spagna, 08041
- Reclutamento
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Spagna, 08035
- Reclutamento
- Hosp Univ Vall D Hebron
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Madrid, Spagna, 28034
- Reclutamento
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spagna, 28041
- Reclutamento
- Hosp. Univ. 12 de Octubre
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Madrid, Spagna, 28007
- Reclutamento
- Hosp. Gral. Univ. Gregorio Maranon
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Madrid, Spagna, 28040
- Reclutamento
- Hosp Univ Fund Jimenez Diaz
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Madrid, Spagna, 28002
- Reclutamento
- Hosp San Francisco de Asis
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Málaga, Spagna, 29010
- Reclutamento
- Hosp Regional Univ de Malaga
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Pamplona, Spagna, 31008
- Reclutamento
- Clinica Univ. de Navarra
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Seville, Spagna, 41013
- Reclutamento
- Hosp. Virgen Del Rocio
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Valencia, Spagna, 46010
- Reclutamento
- Hosp. Clinico Univ. de Valencia
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Arizona
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Chandler, Arizona, Stati Uniti, 85224
- Reclutamento
- Ironwood Cancer and Research Center
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Gilbert, Arizona, Stati Uniti, 85234
- Reclutamento
- Banner MD Anderson Cancer Center
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Prescott, Arizona, Stati Uniti, 86301
- Completato
- Arizona Oncology Associates PC NAHOA
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Arkansas
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Jonesboro, Arkansas, Stati Uniti, 72401
- Reclutamento
- St. Bernard's Medical Center
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Springdale, Arkansas, Stati Uniti, 72762
- Reclutamento
- Highlands Oncology Group
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California
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Bakersfield, California, Stati Uniti, 93309
- Reclutamento
- CBCC Global Research
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Glendale, California, Stati Uniti, 91204
- Reclutamento
- Los Angeles Cancer Network
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Los Alamitos, California, Stati Uniti, 90720
- Reclutamento
- Cancer and Blood Specialty Clinic
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Los Angeles, California, Stati Uniti, 90033
- Reclutamento
- USC Norris Comprehensive Cancer Center
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Santa Monica, California, Stati Uniti, 90404
- Reclutamento
- UCLA
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Santa Rosa, California, Stati Uniti, 95403
- Reclutamento
- Providence Medical Foundation
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Torrance, California, Stati Uniti, 90505
- Reclutamento
- Torrance Memorial Physicians Network
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Reclutamento
- University of Colorado Denver Anschultz Medical Campus
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Denver, Colorado, Stati Uniti, 80218
- Reclutamento
- Rocky Mountain Cancer Centers
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Connecticut
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Norwich, Connecticut, Stati Uniti, 06360
- Completato
- Eastern Connecticut Hematology & Oncology Assoc.
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-
Florida
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Fort Myers, Florida, Stati Uniti, 33901
- Reclutamento
- Florida Cancer Specialists South
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Miami Beach, Florida, Stati Uniti, 33140
- Completato
- Mount Sinai Medical Center Campus
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Orlando, Florida, Stati Uniti, 32804
- Reclutamento
- AdventHealth Cancer Institute
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St. Petersburg, Florida, Stati Uniti, 33701-4553
- Reclutamento
- Florida Cancer Specialists North Region
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West Palm Beach, Florida, Stati Uniti, 33401-3406
- Reclutamento
- Florida Cancer Specialists East
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Georgia
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Athens, Georgia, Stati Uniti, 30607
- Reclutamento
- University Cancer And Blood Center LLC
-
Atlanta, Georgia, Stati Uniti, 30303
- Reclutamento
- Grady Memorial Hospital
-
Atlanta, Georgia, Stati Uniti, 30318
- Reclutamento
- Piedmont Cancer Institute
-
Atlanta, Georgia, Stati Uniti, 30322
- Reclutamento
- Winship Cancer Institute Emory University
-
-
Illinois
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Arlington Heights, Illinois, Stati Uniti, 60005
- Reclutamento
- Illinois Cancer Specialists
-
Peoria, Illinois, Stati Uniti, 61615
- Reclutamento
- Illinois CancerCare
-
-
Indiana
-
Indianapolis, Indiana, Stati Uniti, 46237
- Reclutamento
- Franciscan Health
-
-
Iowa
-
Iowa City, Iowa, Stati Uniti, 52242
- Reclutamento
- University of Iowa Hospitals and Clinics
-
Waukee, Iowa, Stati Uniti, 50263
- Reclutamento
- Mission Cancer Blood
-
-
Kansas
-
Wichita, Kansas, Stati Uniti, 67214
- Reclutamento
- Cancer Center of Kansas
-
-
Louisiana
-
Baton Rouge, Louisiana, Stati Uniti, 70809
- Reclutamento
- Mary Bird Perkins Cancer Center
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21237
- Reclutamento
- MedStar Franklin Square Medical Center
-
Frederick, Maryland, Stati Uniti, 21702
- Reclutamento
- Frederick Health Hospital - James M Stockman Cancer Institute
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48109
- Reclutamento
- University of Michigan Rogel Cancer Center
-
Detroit, Michigan, Stati Uniti, 48202
- Reclutamento
- Henry Ford Hospital
-
Grand Rapids, Michigan, Stati Uniti, 49503
- Reclutamento
- Cancer And Hematology Centers of Western Michigan PC
-
-
Mississippi
-
Hattiesburg, Mississippi, Stati Uniti, 39401
- Reclutamento
- Hattiesburg Clinic
-
-
Missouri
-
St Louis, Missouri, Stati Uniti, 63110
- Reclutamento
- Washington University School Of Medicine
-
-
Nebraska
-
Omaha, Nebraska, Stati Uniti, 68130
- Reclutamento
- Nebraska Cancer Specialists
-
-
New Jersey
-
East Brunswick, New Jersey, Stati Uniti, 08816
- Reclutamento
- Astera Cancer Care
-
-
New York
-
Mineola, New York, Stati Uniti, 11501
- Reclutamento
- Perlmutter Cancer Center at NYU Long Island
-
New York, New York, Stati Uniti, 10016
- Reclutamento
- NYU Langone Medical Center NYU Hematology Associates
-
Shirley, New York, Stati Uniti, 11967
- Reclutamento
- New York Cancer and Blood Specialists
-
The Bronx, New York, Stati Uniti, 10461
- Reclutamento
- Montefiore Einstein Comprehensive Cancer Center
-
Williamsville, New York, Stati Uniti, 14221
- Reclutamento
- University of Buffalo Kaleida Health Cancer Care
-
-
Ohio
-
Canton, Ohio, Stati Uniti, 44718
- Reclutamento
- Gabrail Cancer Center
-
Cleveland, Ohio, Stati Uniti, 44106
- Reclutamento
- University Hospital of Cleveland
-
-
Oregon
-
Portland, Oregon, Stati Uniti, 97239
- Reclutamento
- Oregon Health And Science University
-
-
Pennsylvania
-
Penn Wynne, Pennsylvania, Stati Uniti, 19096
- Reclutamento
- Alliance Cancer Specialists at Main Line
-
Philadelphia, Pennsylvania, Stati Uniti, 19111
- Reclutamento
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Stati Uniti, 19107
- Reclutamento
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, Stati Uniti, 15232 1301
- Reclutamento
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
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-
Tennessee
-
Chattanooga, Tennessee, Stati Uniti, 37404
- Reclutamento
- Tennessee Oncology Chattanooga
-
Nashville, Tennessee, Stati Uniti, 37232
- Reclutamento
- Vanderbilt University Medical Center
-
Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- Tennessee Oncology
-
Nashville, Tennessee, Stati Uniti, 37203
- Reclutamento
- SCRI Oncology Partners
-
-
Texas
-
Abilene, Texas, Stati Uniti, 79606
- Reclutamento
- Texas Oncology West Texas
-
Dallas, Texas, Stati Uniti, 75390
- Reclutamento
- UT Southwestern Medical Center
-
Dallas, Texas, Stati Uniti, 75235
- Reclutamento
- Parkland Health and Hospital System
-
Dallas, Texas, Stati Uniti, 75246
- Reclutamento
- Texas Oncology DFW
-
Houston, Texas, Stati Uniti, 77030
- Reclutamento
- MD Anderson Cancer Center
-
Round Rock, Texas, Stati Uniti, 77845
- Reclutamento
- Baylor Scott & White Medical Center
-
San Antonio, Texas, Stati Uniti, 78240
- Reclutamento
- Texas Oncology - San Antonio
-
Temple, Texas, Stati Uniti, 76508
- Reclutamento
- Scott And White Memorial Hospital
-
Tyler, Texas, Stati Uniti, 75701
- Reclutamento
- UT Health East Texas HOPE Cancer Center
-
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Virginia
-
Arlington, Virginia, Stati Uniti, 22201
- Reclutamento
- Virginia Cancer Specialists
-
Richmond, Virginia, Stati Uniti, 23249
- Reclutamento
- Richmond VA Medical Center
-
Richmond, Virginia, Stati Uniti, 23298
- Reclutamento
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Lacey, Washington, Stati Uniti, 98503
- Reclutamento
- Providence Regional Cancer System
-
Seattle, Washington, Stati Uniti, 98109
- Reclutamento
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, Stati Uniti, 53226
- Reclutamento
- Medical College Of Wisconsin
-
-
-
-
-
Gothenburg, Svezia, 413 45
- Completato
- Sahlgrenska Universitetssjukhuset
-
Lund, Svezia, 222 42
- Reclutamento
- Skanes universitetssjukhus
-
Stockholm, Svezia, 171 76
- Reclutamento
- Karolinska Universitetssjukhuset
-
Stockholm, Svezia, 118 83
- Reclutamento
- Sodersjukhuset
-
Uppsala, Svezia, SE 751 85
- Reclutamento
- Uppsala University
-
-
-
-
-
Bangkok, Tailandia, 10700
- Reclutamento
- Siriraj Hospital
-
Bangkok, Tailandia, 10400
- Reclutamento
- Ramathibodi Hospital
-
Chiang Mai, Tailandia, 50200
- Reclutamento
- Chiang Mai University
-
Songkhla, Tailandia, 90110
- Reclutamento
- Songklanagarind hospital
-
-
-
-
-
Kaohsiung City, Taiwan, 833
- Reclutamento
- Chang Gung Memorial Hospital
-
Kaohsiung City, Taiwan, 80756
- Reclutamento
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Taichung, Taiwan, 40705
- Reclutamento
- Taichung Veterans General Hospital
-
Tainan, Taiwan, 704
- Reclutamento
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 112
- Reclutamento
- Taipei Veterans General Hospital
-
Taipei, Taiwan, 10043
- Reclutamento
- National Taiwan University Hospital
-
Taoyuan, Taiwan, 333
- Reclutamento
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Adana, Turchia (Türkiye), 01060
- Reclutamento
- Adana City Hospital
-
Ankara, Turchia (Türkiye), 06800
- Reclutamento
- Ankara Bilkent Sehir Hastanesi
-
Ankara, Turchia (Türkiye), 06010
- Reclutamento
- Gulhane Egitim ve Arastirma Hastanesi
-
Ankara, Turchia (Türkiye), 06200
- Reclutamento
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
Ankara, Turchia (Türkiye), 06560
- Reclutamento
- Gazi Universitesi Hastanesi
-
Antalya, Turchia (Türkiye), 07025
- Reclutamento
- Memorial Antalya Hospital
-
Edirne, Turchia (Türkiye), 22030
- Reclutamento
- Trakya University Medical Faculty
-
Istanbul, Turchia (Türkiye), 34147
- Reclutamento
- Bakirkoy Training and Research Hospital
-
Istanbul, Turchia (Türkiye), 34899
- Reclutamento
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
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Konya, Turchia (Türkiye), 42090
- Reclutamento
- Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
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Sakarya, Turchia (Türkiye), 54290
- Reclutamento
- Sakarya University Training and Research Hospital
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Eger, Ungheria, 3300
- Completato
- Markhot Ferenc Oktatokorhaz es Rendelointezet
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Pécs, Ungheria, 7624
- Completato
- Pecsi Tudomanyegyetem
-
Szeged, Ungheria, 6720
- Completato
- Szegedi Tudomanyegyetem
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Altri nomi:
Irinotecan will be administered as chemotherapy regimen. |
|
Comparatore attivo: 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.
Altri nomi:
Cetuximab will be administered.
Altri nomi:
Irinotecan will be administered as chemotherapy regimen. Bevacizumab will be administered.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by BICR
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Malattie intestinali
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Neoplasie intestinali
- Malattie del retto
- Malattie del colon
- Neoplasie colorettali
- Aminoacidi, peptidi e proteine
- Proteine
- Composti eterociclici, 1-anello
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Camptothecin
- Alcaloidi
- Enzimi e coenzimi
- Anticorpi, monoclonali, umanizzati
- Anticorpi, monoclonali
- Anticorpi
- Immunoglobuline
- Immunoproteine
- Proteine del sangue
- Globuline sieriche
- Globuline
- Pirimidine
- Formyltetraidrofolates
- Tetraidrofolati
- Acido folico
- Pterins
- Pteridine
- Uracile
- Pirimidinoni
- Coenzimi
- Bevacizumab
- Irinotecano
- Cetuximab
- Fluorouracile
- Leucovorina
- Levoleucovorin
- amivantamab
Altri numeri di identificazione dello studio
- 61186372COR3002
- 2024-513853-66-00 (Identificatore di registro: EUCT number)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .