阿米万他单抗和 FOLFIRI 与西妥昔单抗/贝伐珠单抗和 FOLFIRI 在既往接受过化疗的 KRAS/NRAS 和 BRAF 野生型结直肠癌受试者中的研究 (OrigAMI-3)
在既往接受过化疗的 KRAS/NRAS 和 BRAF 野生型复发性、不可切除或转移性结直肠癌受试者中进行阿米万他单抗 + FOLFIRI 与西妥昔单抗/贝伐珠单抗 + FOLFIRI 的随机、开放标签 3 期研究
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.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 第三阶段
扩展访问
联系人和位置
学习联系方式
- 姓名：Study Contact
- 电话号码：844-434-4210
- 邮箱：Participate-In-This-Study1@its.jnj.com
学习地点
-
-
-
Beijing、中国、100142
- 招聘中
- Beijing Cancer Hospital
-
Beijing、中国、100034
- 招聘中
- Peking University First Hospital
-
Beijing、中国、100050
- 招聘中
- Beijing Friendship Hospital Capital Medical University
-
Changchun、中国、130021
- 招聘中
- The First Bethune Hospital of Jilin University
-
Changsha、中国、410013
- 招聘中
- Hunan Cancer hospital
-
Chengdu、中国、610041
- 招聘中
- West China Hospital of Sichuan University
-
Ganzhou、中国、341000
- 招聘中
- Ganzhou Cancer Hospital
-
Guangzhou、中国、510655
- 招聘中
- The Sixth Affiliated Hospital Sun Yat sen University
-
Guangzhou、中国、519041
- 招聘中
- Guangdong Provincial People's Hospital
-
Guangzhou、中国、100142
- 招聘中
- Sun Yat Sen University Cancer Center
-
Hangzhou、中国、310022
- 招聘中
- Zhejiang Cancer Hospital
-
Hangzhou、中国、310009
- 招聘中
- The Second Affiliated Hospital of Zhejiang University
-
Harbin、中国、150081
- 招聘中
- Harbin medical university cancer hospital
-
Huizhou、中国、516001
- 招聘中
- Huizhou Central People's Hospital
-
Lanzhou、中国、730050
- 招聘中
- Gansu Provincial Cancer Hospital
-
Nanchang、中国、330006
- 招聘中
- The First Affiliated Hospital of NanChang University
-
Shanghai、中国、200032
- 招聘中
- Fudan University Shanghai Cancer Center
-
Shenyang、中国、110042
- 招聘中
- Liaoning Cancer Hospital and Institute
-
Tianjin、中国、300060
- 招聘中
- Tianjin Medical University Cancer Institute and Hospital
-
Wuhan、中国、430079
- 招聘中
- Hubei Cancer Hospital
-
-
-
-
-
Beer Yaakov、以色列、70300
- 招聘中
- Yitzhak Shamir Medical Center
-
Haifa、以色列、3109601
- 招聘中
- Rambam Medical Center
-
Jerusalem、以色列、9112001
- 招聘中
- Hadassah Medical Center
-
Petah Tikva、以色列、4941492
- 招聘中
- Rabin Medical Center
-
Ramat Gan、以色列、52621
- 招聘中
- Sheba Medical Center
-
Tel Aviv、以色列、6423906
- 招聘中
- Tel Aviv Sourasky Medical Center
-
Tel Aviv、以色列、69710
- 招聘中
- Assuta MC
-
-
-
-
-
Eger、匈牙利、3300
- 完全的
- Markhot Ferenc Oktatokorhaz es Rendelointezet
-
Pécs、匈牙利、7624
- 完全的
- Pecsi Tudomanyegyetem
-
Szeged、匈牙利、6720
- 完全的
- Szegedi Tudomanyegyetem
-
-
-
-
-
Delhi、印度、110085
- 招聘中
- Rajiv Gandhi Cancer Institute and Research Centre
-
Hyderabad、印度、500032
- 招聘中
- Asian Institute Of Gastroenterology
-
Kolkata、印度、700053
- 招聘中
- B P Poddar Hospital and Medical research Limited
-
Mumbai、印度、400012
- 招聘中
- Tata Memorial Hospital
-
New Delhi、印度、110029
- 招聘中
- Safdarjung Hospital
-
Pune、印度、411004
- 招聘中
- Deenanath Mangeshkar Hospital and Research Centre
-
Varanasi、印度、221005
- 招聘中
- Mahamana Pandit Madan Mohan Malviya Cancer Centre
-
Vellore、印度、632004
- 招聘中
- Christian medical
-
-
-
-
-
Kaohsiung City、台湾、833
- 招聘中
- Chang Gung Memorial Hospital
-
Kaohsiung City、台湾、80756
- 招聘中
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Taichung、台湾、40705
- 招聘中
- Taichung Veterans General Hospital
-
Tainan、台湾、704
- 招聘中
- National Cheng Kung University Hospital
-
Taipei、台湾、112
- 招聘中
- Taipei Veterans General Hospital
-
Taipei、台湾、10043
- 招聘中
- National Taiwan University Hospital
-
Taoyuan、台湾、333
- 招聘中
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Adana、土耳其（türkiye）、01060
- 招聘中
- Adana City Hospital
-
Ankara、土耳其（türkiye）、06800
- 招聘中
- Ankara Bilkent Sehir Hastanesi
-
Ankara、土耳其（türkiye）、06010
- 招聘中
- Gulhane Egitim ve Arastirma Hastanesi
-
Ankara、土耳其（türkiye）、06200
- 招聘中
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
Ankara、土耳其（türkiye）、06560
- 招聘中
- Gazi Universitesi Hastanesi
-
Antalya、土耳其（türkiye）、07025
- 招聘中
- Memorial Antalya Hospital
-
Edirne、土耳其（türkiye）、22030
- 招聘中
- Trakya University Medical Faculty
-
Istanbul、土耳其（türkiye）、34147
- 招聘中
- Bakirkoy Training and Research Hospital
-
Istanbul、土耳其（türkiye）、34899
- 招聘中
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
-
Konya、土耳其（türkiye）、42090
- 招聘中
- Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
-
Sakarya、土耳其（türkiye）、54290
- 招聘中
- Sakarya University Training and Research Hospital
-
-
-
-
-
Chihuahua City、墨西哥、31217
- 招聘中
- Centro Oncologico de Chihuahua
-
Guadalajara、墨西哥、44680
- 招聘中
- Actualidad Basada En La Investigacion Del Cancer
-
Mexico City、墨西哥、14080
- 招聘中
- Instituto Nacional de Cancerologia
-
Mexico City、墨西哥、06760
- 招聘中
- Centro Oncologico Personalizado Cope S De R L De C V
-
Monterrey、墨西哥、64460
- 招聘中
- Hospital Universitario Dr Jose Eleuterio Gonzalez
-
Puebla City、墨西哥、72530
- 招聘中
- Oncocenter
-
Querétaro、墨西哥、76000
- 招聘中
- Cuidados Oncologicos
-
Querétaro、墨西哥、76230
- 招聘中
- Health Pharma Queretaro SA de CV
-
Tijuana、墨西哥、22010
- 招聘中
- COI Centro Oncologico Internacional Tijuana
-
-
-
-
-
Barretos、巴西、14780 070
- 招聘中
- Fundacao Pio XII
-
Caxias do Sul、巴西、95070 560
- 招聘中
- Fundacao Universidade de Caxias do Sul
-
Jaú、巴西、17210 080
- 招聘中
- Fundacao Doutor Amaral Carvalho
-
Porto Alegre、巴西、91350 200
- 招聘中
- Hospital Nossa Senhora da Conceicao S A
-
Salvador、巴西、40050 410
- 招聘中
- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
-
São José do Rio Preto、巴西、15090-000
- 招聘中
- Funfarme Sjrp
-
São Paulo、巴西、01246 000
- 招聘中
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
-
São Paulo、巴西、01509 900
- 招聘中
- Fundacao Antonio Prudente A C Camargo Cancer Center
-
São Paulo、巴西、05651 900
- 招聘中
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
-
Vitória、巴西、29043 260
- 招聘中
- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
-
-
-
-
-
Berlin、德国、13353
- 招聘中
- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
-
Frankfurt am Main、德国、60488
- 招聘中
- Krankenhaus NorthWest
-
Heidelberg、德国、69120
- 招聘中
- National Center for Tumor Diseases NCT
-
Mainz、德国、55131
- 招聘中
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
-
Munich、德国、81377
- 招聘中
- Klinikum der Universitaet Muenchen
-
-
-
-
-
Catania、意大利、95122
- 招聘中
- ARNAS Garibaldi P O Nesima
-
Florence、意大利、50134
- 招聘中
- Careggi University Hospital
-
Milan、意大利、20133
- 招聘中
- Istituto Dei Tumori Di Milano
-
Novara、意大利、28100
- 招聘中
- Fondazione del Piemonte per I Oncologia IRCC Candiolo
-
Padova、意大利、35128
- 招聘中
- Istituto Oncologico Veneto - IRCCS
-
Pisa、意大利、56126
- 招聘中
- Azienda Ospedaliero Universitaria Pisana
-
Rozzano、意大利、20089
- 招聘中
- Istituto Clinico Humanitas
-
Udine、意大利、33100
- 完全的
- Azienda Sanitaria Universitaria Friuli Centrale ASU FC
-
-
-
-
-
Chiba、日本、260 0801
- 招聘中
- Chiba Cancer Center
-
Chūōku、日本、104 0045
- 招聘中
- National Cancer Center Hospital
-
Kashiwa、日本、277 8577
- 招聘中
- National Cancer Center Hospital East
-
Nagoya、日本、464-8681
- 招聘中
- Aichi Cancer Center
-
Osaka、日本、541 8567
- 招聘中
- Osaka International Cancer Institute
-
Osaka、日本、540 0006
- 招聘中
- National Hospital Organization Osaka National Hospital
-
Sakai、日本、590 0197
- 招聘中
- Kindai University Hospital
-
Shizuoka、日本、411 8777
- 招聘中
- Shizuoka Cancer Center
-
Suita、日本、565 0871
- 招聘中
- The University of Osaka Hospital
-
Tokyo、日本、135 8550
- 招聘中
- The Cancer Institute Hospital of JFCR
-
-
-
-
-
Anderlecht、比利时、1070
- 招聘中
- Institut Jules Bordet
-
Edegem、比利时、2650
- 招聘中
- UZ Antwerpen
-
Ghent、比利时、9000
- 完全的
- AZ Maria Middelares
-
Haine Saint Paul La Louviere、比利时、7100
- 招聘中
- Jolimont
-
Kortrijk、比利时、8500
- 招聘中
- Az Groeninge
-
Leuven、比利时、3000
- 招聘中
- Universitair Ziekenhuis Leuven
-
Liège、比利时、4000
- 招聘中
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
-
-
-
-
-
Avignon、法国、84918
- 招聘中
- Institut Sainte Catherine
-
Pessac、法国、33604
- 招聘中
- Hopital Haut Leveque
-
Poitiers、法国、86000
- 招聘中
- CHU De Poitiers
-
-
-
-
-
Bialystok、波兰、15 027
- 完全的
- Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
-
Biała Podlaska、波兰、21 500
- 完全的
- Wojewodzki Szpital Specjalistyczny
-
Brzozów、波兰、36 200
- 招聘中
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
-
Gdansk、波兰、80 214
- 招聘中
- Uniwersyteckie Centrum Kliniczne
-
Gliwice、波兰、44 100
- 完全的
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
-
Lodz、波兰、93 339
- 招聘中
- Instytut Centrum Zdrowia Matki Polki
-
Olsztyn、波兰、10 228
- 完全的
- Szpital Kliniczny MSWiA z WMCO
-
Opole、波兰、45 061
- 招聘中
- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
-
Warsaw、波兰、02 034
- 招聘中
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
-
-
-
-
-
San Juan、波多黎各、00935
- 招聘中
- Pan American Center for Oncology Trials LLC
-
-
-
-
-
Bangkok、泰国、10700
- 招聘中
- Siriraj Hospital
-
Bangkok、泰国、10400
- 招聘中
- Ramathibodi Hospital
-
Chiang Mai、泰国、50200
- 招聘中
- Chiang Mai University
-
Songkhla、泰国、90110
- 招聘中
- Songklanagarind hospital
-
-
-
-
-
Concord、澳大利亚、2139
- 完全的
- Concord Hospital
-
Heidelberg、澳大利亚、3084
- 招聘中
- Warringal Private Hospital
-
South Woodville、澳大利亚、5011
- 招聘中
- Queen Elizabeth Hospital
-
St Albans、澳大利亚、3021
- 招聘中
- Western Health Sunshine Hospital
-
-
-
-
-
Gothenburg、瑞典、413 45
- 完全的
- Sahlgrenska Universitetssjukhuset
-
Lund、瑞典、222 42
- 招聘中
- Skanes universitetssjukhus
-
Stockholm、瑞典、171 76
- 招聘中
- Karolinska Universitetssjukhuset
-
Stockholm、瑞典、118 83
- 招聘中
- Sodersjukhuset
-
Uppsala、瑞典、SE 751 85
- 招聘中
- Uppsala University
-
-
-
-
-
Brasov、罗马尼亚、500091
- 招聘中
- Centrul Medical Unirea SRL
-
Bucharest、罗马尼亚、013812
- 招聘中
- Spitalul Memorial Baneasa
-
Bucharest、罗马尼亚、014142
- 完全的
- Ponderas Academic Hospital
-
Bucharest、罗马尼亚、077190
- 完全的
- Neolife Medical Center Bucharest
-
Cluj-Napoca、罗马尼亚、400015
- 招聘中
- Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca
-
Craiova、罗马尼亚、200542
- 招聘中
- Clinica de Oncologie Sf Nectarie
-
Iași、罗马尼亚、700483
- 招聘中
- Institutul Regional de Oncologie Iasi
-
Oradea、罗马尼亚、410469
- 招聘中
- Pelican Impex SRL
-
-
-
-
Arizona
-
Chandler、Arizona、美国、85224
- 招聘中
- Ironwood Cancer and Research Center
-
Gilbert、Arizona、美国、85234
- 招聘中
- Banner MD Anderson Cancer Center
-
Prescott、Arizona、美国、86301
- 完全的
- Arizona Oncology Associates PC NAHOA
-
-
Arkansas
-
Jonesboro、Arkansas、美国、72401
- 招聘中
- St. Bernard's Medical Center
-
Springdale、Arkansas、美国、72762
- 招聘中
- Highlands Oncology Group
-
-
California
-
Bakersfield、California、美国、93309
- 招聘中
- CBCC Global Research
-
Glendale、California、美国、91204
- 招聘中
- Los Angeles Cancer Network
-
Los Alamitos、California、美国、90720
- 招聘中
- Cancer and Blood Specialty Clinic
-
Los Angeles、California、美国、90033
- 招聘中
- USC Norris Comprehensive Cancer Center
-
Santa Monica、California、美国、90404
- 招聘中
- UCLA
-
Santa Rosa、California、美国、95403
- 招聘中
- Providence Medical Foundation
-
Torrance、California、美国、90505
- 招聘中
- Torrance Memorial Physicians Network
-
-
Colorado
-
Aurora、Colorado、美国、80045
- 招聘中
- University of Colorado Denver Anschultz Medical Campus
-
Denver、Colorado、美国、80218
- 招聘中
- Rocky Mountain Cancer Centers
-
-
Connecticut
-
Norwich、Connecticut、美国、06360
- 完全的
- Eastern Connecticut Hematology & Oncology Assoc.
-
-
Florida
-
Fort Myers、Florida、美国、33901
- 招聘中
- Florida Cancer Specialists South
-
Miami Beach、Florida、美国、33140
- 完全的
- Mount Sinai Medical Center Campus
-
Orlando、Florida、美国、32804
- 招聘中
- AdventHealth Cancer Institute
-
St. Petersburg、Florida、美国、33701-4553
- 招聘中
- Florida Cancer Specialists North Region
-
West Palm Beach、Florida、美国、33401-3406
- 招聘中
- Florida Cancer Specialists East
-
-
Georgia
-
Athens、Georgia、美国、30607
- 招聘中
- University Cancer And Blood Center LLC
-
Atlanta、Georgia、美国、30303
- 招聘中
- Grady Memorial Hospital
-
Atlanta、Georgia、美国、30318
- 招聘中
- Piedmont Cancer Institute
-
Atlanta、Georgia、美国、30322
- 招聘中
- Winship Cancer Institute Emory University
-
-
Illinois
-
Arlington Heights、Illinois、美国、60005
- 招聘中
- Illinois Cancer Specialists
-
Peoria、Illinois、美国、61615
- 招聘中
- Illinois CancerCare
-
-
Indiana
-
Indianapolis、Indiana、美国、46237
- 招聘中
- Franciscan Health
-
-
Iowa
-
Iowa City、Iowa、美国、52242
- 招聘中
- University of Iowa Hospitals and Clinics
-
Waukee、Iowa、美国、50263
- 招聘中
- Mission Cancer Blood
-
-
Kansas
-
Wichita、Kansas、美国、67214
- 招聘中
- Cancer Center of Kansas
-
-
Louisiana
-
Baton Rouge、Louisiana、美国、70809
- 招聘中
- Mary Bird Perkins Cancer Center
-
-
Maryland
-
Baltimore、Maryland、美国、21237
- 招聘中
- MedStar Franklin Square Medical Center
-
Frederick、Maryland、美国、21702
- 招聘中
- Frederick Health Hospital - James M Stockman Cancer Institute
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- 招聘中
- University of Michigan Rogel Cancer Center
-
Detroit、Michigan、美国、48202
- 招聘中
- Henry Ford Hospital
-
Grand Rapids、Michigan、美国、49503
- 招聘中
- Cancer And Hematology Centers of Western Michigan PC
-
-
Mississippi
-
Hattiesburg、Mississippi、美国、39401
- 招聘中
- Hattiesburg Clinic
-
-
Missouri
-
St Louis、Missouri、美国、63110
- 招聘中
- Washington University School Of Medicine
-
-
Nebraska
-
Omaha、Nebraska、美国、68130
- 招聘中
- Nebraska Cancer Specialists
-
-
New Jersey
-
East Brunswick、New Jersey、美国、08816
- 招聘中
- Astera Cancer Care
-
-
New York
-
Mineola、New York、美国、11501
- 招聘中
- Perlmutter Cancer Center at NYU Long Island
-
New York、New York、美国、10016
- 招聘中
- NYU Langone Medical Center NYU Hematology Associates
-
Shirley、New York、美国、11967
- 招聘中
- New York Cancer and Blood Specialists
-
The Bronx、New York、美国、10461
- 招聘中
- Montefiore Einstein Comprehensive Cancer Center
-
Williamsville、New York、美国、14221
- 招聘中
- University of Buffalo Kaleida Health Cancer Care
-
-
Ohio
-
Canton、Ohio、美国、44718
- 招聘中
- Gabrail Cancer Center
-
Cleveland、Ohio、美国、44106
- 招聘中
- University Hospital of Cleveland
-
-
Oregon
-
Portland、Oregon、美国、97239
- 招聘中
- Oregon Health And Science University
-
-
Pennsylvania
-
Penn Wynne、Pennsylvania、美国、19096
- 招聘中
- Alliance Cancer Specialists at Main Line
-
Philadelphia、Pennsylvania、美国、19111
- 招聘中
- Fox Chase Cancer Center
-
Philadelphia、Pennsylvania、美国、19107
- 招聘中
- Thomas Jefferson University
-
Pittsburgh、Pennsylvania、美国、15232 1301
- 招聘中
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
-
-
Tennessee
-
Chattanooga、Tennessee、美国、37404
- 招聘中
- Tennessee Oncology Chattanooga
-
Nashville、Tennessee、美国、37232
- 招聘中
- Vanderbilt University Medical Center
-
Nashville、Tennessee、美国、37203
- 招聘中
- Tennessee Oncology
-
Nashville、Tennessee、美国、37203
- 招聘中
- SCRI Oncology Partners
-
-
Texas
-
Abilene、Texas、美国、79606
- 招聘中
- Texas Oncology West Texas
-
Dallas、Texas、美国、75390
- 招聘中
- UT Southwestern Medical Center
-
Dallas、Texas、美国、75235
- 招聘中
- Parkland Health and Hospital System
-
Dallas、Texas、美国、75246
- 招聘中
- Texas Oncology DFW
-
Houston、Texas、美国、77030
- 招聘中
- MD Anderson Cancer Center
-
Round Rock、Texas、美国、77845
- 招聘中
- Baylor Scott & White Medical Center
-
San Antonio、Texas、美国、78240
- 招聘中
- Texas Oncology - San Antonio
-
Temple、Texas、美国、76508
- 招聘中
- Scott And White Memorial Hospital
-
Tyler、Texas、美国、75701
- 招聘中
- UT Health East Texas HOPE Cancer Center
-
-
Virginia
-
Arlington、Virginia、美国、22201
- 招聘中
- Virginia Cancer Specialists
-
Richmond、Virginia、美国、23249
- 招聘中
- Richmond VA Medical Center
-
Richmond、Virginia、美国、23298
- 招聘中
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Lacey、Washington、美国、98503
- 招聘中
- Providence Regional Cancer System
-
Seattle、Washington、美国、98109
- 招聘中
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Milwaukee、Wisconsin、美国、53226
- 招聘中
- Medical College Of Wisconsin
-
-
-
-
-
Birmingham、英国、B9 5ST
- 招聘中
- Birmingham Heartlands Hospital
-
Hull、英国、HU16 5JQ
- 招聘中
- Castle Hill Hospital
-
Leeds、英国、LS9 7TF
- 招聘中
- St James University Hospital
-
London、英国、EC1A 7BE
- 招聘中
- St Bartholomew's Hospital
-
London、英国、SW3 6JJ
- 招聘中
- Royal Marsden Hospital
-
London、英国、NW1 2BU
- 招聘中
- University College Hospital
-
Northwood、英国、HA6 2RN
- 招聘中
- Mount Vernon Cancer Centre
-
-
-
-
-
Amersfoort、荷兰、3813 TZ
- 招聘中
- Meander Medisch Centrum
-
Amsterdam、荷兰、1066 CX
- 招聘中
- Antoni van Leeuwenhoek
-
Nijmegen、荷兰、6525 GA
- 招聘中
- Radboud University Medical Center
-
Rotterdam、荷兰、3015 GD
- 招聘中
- Erasmus MC
-
Tilburg、荷兰、5042 AD
- 招聘中
- ETZ TweeSteden
-
-
-
-
-
Badajoz、西班牙、06006
- 招聘中
- Hosp. Univ. de Badajoz
-
Barcelona、西班牙、08028
- 招聘中
- Hosp. Univ. Quiron Dexeus
-
Barcelona、西班牙、08003
- 招聘中
- Hosp. Del Mar
-
Barcelona、西班牙、08041
- 招聘中
- Hosp. de La Santa Creu I Sant Pau
-
Barcelona、西班牙、08035
- 招聘中
- Hosp Univ Vall D Hebron
-
Madrid、西班牙、28034
- 招聘中
- Hosp. Univ. Ramon Y Cajal
-
Madrid、西班牙、28041
- 招聘中
- Hosp. Univ. 12 de Octubre
-
Madrid、西班牙、28007
- 招聘中
- Hosp. Gral. Univ. Gregorio Maranon
-
Madrid、西班牙、28040
- 招聘中
- Hosp Univ Fund Jimenez Diaz
-
Madrid、西班牙、28002
- 招聘中
- Hosp San Francisco de Asis
-
Málaga、西班牙、29010
- 招聘中
- Hosp Regional Univ de Malaga
-
Pamplona、西班牙、31008
- 招聘中
- Clinica Univ. de Navarra
-
Seville、西班牙、41013
- 招聘中
- Hosp. Virgen Del Rocio
-
Valencia、西班牙、46010
- 招聘中
- Hosp. Clinico Univ. de Valencia
-
-
-
-
-
Daegu、韩国、41404
- 招聘中
- Kyungpook National University Chilgok Hospital
-
Seoul、韩国、05505
- 招聘中
- Asan Medical Center
-
Seoul、韩国、03080
- 招聘中
- Seoul National University Hospital
-
Seoul、韩国、06351
- 招聘中
- Samsung Medical Center
-
Seoul、韩国、02841
- 招聘中
- Korea University Anam Hospital
-
Seoul、韩国、03722
- 招聘中
- Severance Hospital Yonsei University Health System
-
Seoul、韩国、06591
- 招聘中
- The Catholic University of Korea Seoul St Mary s Hospital
-
-
-
-
-
Hong Kong、香港
- 招聘中
- Queen Mary Hospital
-
Shatin、香港
- 招聘中
- Prince Of Wales Hospital
-
-
-
-
-
George Town、马来西亚、10450
- 招聘中
- Hospital Pulau Pinang
-
Ipoh、马来西亚、30450
- 招聘中
- Hospital Raja Permaisuri Bainun
-
Kuala Lumpur、马来西亚、59100
- 招聘中
- University Malaya Medical Centre
-
Kuala Lumpur、马来西亚、50586
- 招聘中
- Hospital Kuala Lumpur
-
Kuching、马来西亚、93586
- 招聘中
- Hospital Umum Sarawak
-
Putrajaya、马来西亚、62250
- 招聘中
- Institut Kanser Negara Clinical Research Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
其他名称：
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
其他名称：
Irinotecan will be administered as chemotherapy regimen. |
|
有源比较器：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.
其他名称：
Cetuximab will be administered.
其他名称：
Irinotecan will be administered as chemotherapy regimen. Bevacizumab will be administered.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
大体时间：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)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by BICR
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
调查人员
- 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 61186372COR3002
- 2024-513853-66-00 (注册表标识符：EUCT number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.