이전에 화학요법을 받은 KRAS/NRAS 및 BRAF 야생형 대장암 참가자를 대상으로 한 Amivantamab 및 FOLFIRI 대 Cetuximab/Bevacizumab 및 FOLFIRI에 대한 연구 (OrigAMI-3)
이전에 화학요법을 받은 적이 있는 KRAS/NRAS 및 BRAF 야생형 재발성, 절제 불가능 또는 전이성 대장암 참가자를 대상으로 한 Amivantamab + FOLFIRI 대 Cetuximab/Bevacizumab + FOLFIRI의 무작위 공개 제3상 연구
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
확장된 액세스
확장된 액세스
승인됨
- 사용 가능: 현재 이 연구 치료에 대해 확장된 액세스가 가능하며 임상 연구에 참여하지 않은 환자는 약물, 생물학적 제제 또는 의료 기기에 액세스할 수 있습니다. 연구 중입니다.
- 더 이상 사용할 수 없음: 이전에는 이 개입에 대해 확장된 액세스를 사용할 수 있었지만 현재 사용할 수 없으며 앞으로도 사용할 수 없습니다.
- 일시적으로 사용할 수 없음: 현재 이 개입에 대해 확장된 액세스를 사용할 수 없지만 향후 사용할 수 있을 것으로 예상됩니다.
- 마케팅 승인: 개입 대중이 사용할 수 있도록 미국 식품의약국(FDA)의 승인을 받았습니다.
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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-
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Amersfoort, 네덜란드, 3813 TZ
- 모병
- Meander Medisch Centrum
-
Amsterdam, 네덜란드, 1066 CX
- 모병
- Antoni van Leeuwenhoek
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Nijmegen, 네덜란드, 6525 GA
- 모병
- Radboud University Medical Center
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Rotterdam, 네덜란드, 3015 GD
- 모병
- Erasmus MC
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Tilburg, 네덜란드, 5042 AD
- 모병
- ETZ TweeSteden
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-
-
-
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Kaohsiung City, 대만, 833
- 모병
- Chang Gung Memorial Hospital
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Kaohsiung City, 대만, 80756
- 모병
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taichung, 대만, 40705
- 모병
- Taichung Veterans General Hospital
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Tainan, 대만, 704
- 모병
- National Cheng Kung University Hospital
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Taipei, 대만, 112
- 모병
- Taipei Veterans General Hospital
-
Taipei, 대만, 10043
- 모병
- National Taiwan University Hospital
-
Taoyuan, 대만, 333
- 모병
- Linkou Chang Gung Memorial Hospital
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-
-
-
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Daegu, 대한민국, 41404
- 모병
- Kyungpook National University Chilgok Hospital
-
Seoul, 대한민국, 05505
- 모병
- Asan Medical Center
-
Seoul, 대한민국, 03080
- 모병
- Seoul National University Hospital
-
Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
-
Seoul, 대한민국, 02841
- 모병
- Korea University Anam Hospital
-
Seoul, 대한민국, 03722
- 모병
- Severance Hospital Yonsei University Health System
-
Seoul, 대한민국, 06591
- 모병
- The Catholic University of Korea Seoul St Mary s Hospital
-
-
-
-
-
Berlin, 독일, 13353
- 모병
- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
-
Frankfurt am Main, 독일, 60488
- 모병
- Krankenhaus NorthWest
-
Heidelberg, 독일, 69120
- 모병
- National Center for Tumor Diseases NCT
-
Mainz, 독일, 55131
- 모병
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
-
Munich, 독일, 81377
- 모병
- Klinikum der Universitaet Muenchen
-
-
-
-
-
Brasov, 루마니아, 500091
- 모병
- Centrul Medical Unirea SRL
-
Bucharest, 루마니아, 013812
- 모병
- Spitalul Memorial Baneasa
-
Bucharest, 루마니아, 014142
- 완전한
- Ponderas Academic Hospital
-
Bucharest, 루마니아, 077190
- 완전한
- Neolife Medical Center Bucharest
-
Cluj-Napoca, 루마니아, 400015
- 모병
- Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca
-
Craiova, 루마니아, 200542
- 모병
- Clinica de Oncologie Sf Nectarie
-
Iași, 루마니아, 700483
- 모병
- Institutul Regional de Oncologie Iasi
-
Oradea, 루마니아, 410469
- 모병
- Pelican Impex SRL
-
-
-
-
-
George Town, 말레이시아, 10450
- 모병
- Hospital Pulau Pinang
-
Ipoh, 말레이시아, 30450
- 모병
- Hospital Raja Permaisuri Bainun
-
Kuala Lumpur, 말레이시아, 59100
- 모병
- University Malaya Medical Centre
-
Kuala Lumpur, 말레이시아, 50586
- 모병
- Hospital Kuala Lumpur
-
Kuching, 말레이시아, 93586
- 모병
- Hospital Umum Sarawak
-
Putrajaya, 말레이시아, 62250
- 모병
- Institut Kanser Negara Clinical Research Center
-
-
-
-
-
Chihuahua City, 멕시코, 31217
- 모병
- Centro Oncologico de Chihuahua
-
Guadalajara, 멕시코, 44680
- 모병
- Actualidad Basada En La Investigacion Del Cancer
-
Mexico City, 멕시코, 14080
- 모병
- Instituto Nacional de Cancerologia
-
Mexico City, 멕시코, 06760
- 모병
- Centro Oncologico Personalizado Cope S De R L De C V
-
Monterrey, 멕시코, 64460
- 모병
- Hospital Universitario Dr Jose Eleuterio Gonzalez
-
Puebla City, 멕시코, 72530
- 모병
- Oncocenter
-
Querétaro, 멕시코, 76000
- 모병
- Cuidados Oncologicos
-
Querétaro, 멕시코, 76230
- 모병
- Health Pharma Queretaro SA de CV
-
Tijuana, 멕시코, 22010
- 모병
- COI Centro Oncologico Internacional Tijuana
-
-
-
-
Arizona
-
Chandler, Arizona, 미국, 85224
- 모병
- Ironwood Cancer and Research Center
-
Gilbert, Arizona, 미국, 85234
- 모병
- Banner MD Anderson Cancer Center
-
Prescott, Arizona, 미국, 86301
- 완전한
- Arizona Oncology Associates PC NAHOA
-
-
Arkansas
-
Jonesboro, Arkansas, 미국, 72401
- 모병
- St. Bernard's Medical Center
-
Springdale, Arkansas, 미국, 72762
- 모병
- Highlands Oncology Group
-
-
California
-
Bakersfield, California, 미국, 93309
- 모병
- CBCC Global Research
-
Glendale, California, 미국, 91204
- 모병
- Los Angeles Cancer Network
-
Los Alamitos, California, 미국, 90720
- 모병
- Cancer and Blood Specialty Clinic
-
Los Angeles, California, 미국, 90033
- 모병
- USC Norris Comprehensive Cancer Center
-
Santa Monica, California, 미국, 90404
- 모병
- UCLA
-
Santa Rosa, California, 미국, 95403
- 모병
- Providence Medical Foundation
-
Torrance, California, 미국, 90505
- 모병
- Torrance Memorial Physicians Network
-
-
Colorado
-
Aurora, Colorado, 미국, 80045
- 모병
- University of Colorado Denver Anschultz Medical Campus
-
Denver, Colorado, 미국, 80218
- 모병
- Rocky Mountain Cancer Centers
-
-
Connecticut
-
Norwich, Connecticut, 미국, 06360
- 완전한
- Eastern Connecticut Hematology & Oncology Assoc.
-
-
Florida
-
Fort Myers, Florida, 미국, 33901
- 모병
- Florida Cancer Specialists South
-
Miami Beach, Florida, 미국, 33140
- 완전한
- Mount Sinai Medical Center Campus
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Orlando, Florida, 미국, 32804
- 모병
- AdventHealth Cancer Institute
-
St. Petersburg, Florida, 미국, 33701-4553
- 모병
- Florida Cancer Specialists North Region
-
West Palm Beach, Florida, 미국, 33401-3406
- 모병
- Florida Cancer Specialists East
-
-
Georgia
-
Athens, Georgia, 미국, 30607
- 모병
- University Cancer And Blood Center LLC
-
Atlanta, Georgia, 미국, 30303
- 모병
- Grady Memorial Hospital
-
Atlanta, Georgia, 미국, 30318
- 모병
- Piedmont Cancer Institute
-
Atlanta, Georgia, 미국, 30322
- 모병
- Winship Cancer Institute Emory University
-
-
Illinois
-
Arlington Heights, Illinois, 미국, 60005
- 모병
- Illinois Cancer Specialists
-
Peoria, Illinois, 미국, 61615
- 모병
- Illinois CancerCare
-
-
Indiana
-
Indianapolis, Indiana, 미국, 46237
- 모병
- Franciscan Health
-
-
Iowa
-
Iowa City, Iowa, 미국, 52242
- 모병
- University of Iowa Hospitals and Clinics
-
Waukee, Iowa, 미국, 50263
- 모병
- Mission Cancer Blood
-
-
Kansas
-
Wichita, Kansas, 미국, 67214
- 모병
- Cancer Center of Kansas
-
-
Louisiana
-
Baton Rouge, Louisiana, 미국, 70809
- 모병
- Mary Bird Perkins Cancer Center
-
-
Maryland
-
Baltimore, Maryland, 미국, 21237
- 모병
- MedStar Franklin Square Medical Center
-
Frederick, Maryland, 미국, 21702
- 모병
- Frederick Health Hospital - James M Stockman Cancer Institute
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109
- 모병
- University of Michigan Rogel Cancer Center
-
Detroit, Michigan, 미국, 48202
- 모병
- Henry Ford Hospital
-
Grand Rapids, Michigan, 미국, 49503
- 모병
- Cancer And Hematology Centers of Western Michigan PC
-
-
Mississippi
-
Hattiesburg, Mississippi, 미국, 39401
- 모병
- Hattiesburg Clinic
-
-
Missouri
-
St Louis, Missouri, 미국, 63110
- 모병
- Washington University School Of Medicine
-
-
Nebraska
-
Omaha, Nebraska, 미국, 68130
- 모병
- Nebraska Cancer Specialists
-
-
New Jersey
-
East Brunswick, New Jersey, 미국, 08816
- 모병
- Astera Cancer Care
-
-
New York
-
Mineola, New York, 미국, 11501
- 모병
- Perlmutter Cancer Center at NYU Long Island
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New York, New York, 미국, 10016
- 모병
- NYU Langone Medical Center NYU Hematology Associates
-
Shirley, New York, 미국, 11967
- 모병
- New York Cancer and Blood Specialists
-
The Bronx, New York, 미국, 10461
- 모병
- Montefiore Einstein Comprehensive Cancer Center
-
Williamsville, New York, 미국, 14221
- 모병
- University of Buffalo Kaleida Health Cancer Care
-
-
Ohio
-
Canton, Ohio, 미국, 44718
- 모병
- Gabrail Cancer Center
-
Cleveland, Ohio, 미국, 44106
- 모병
- University Hospital of Cleveland
-
-
Oregon
-
Portland, Oregon, 미국, 97239
- 모병
- Oregon Health And Science University
-
-
Pennsylvania
-
Penn Wynne, Pennsylvania, 미국, 19096
- 모병
- Alliance Cancer Specialists at Main Line
-
Philadelphia, Pennsylvania, 미국, 19111
- 모병
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, 미국, 19107
- 모병
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, 미국, 15232 1301
- 모병
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
-
-
Tennessee
-
Chattanooga, Tennessee, 미국, 37404
- 모병
- Tennessee Oncology Chattanooga
-
Nashville, Tennessee, 미국, 37232
- 모병
- Vanderbilt University Medical Center
-
Nashville, Tennessee, 미국, 37203
- 모병
- Tennessee Oncology
-
Nashville, Tennessee, 미국, 37203
- 모병
- SCRI Oncology Partners
-
-
Texas
-
Abilene, Texas, 미국, 79606
- 모병
- Texas Oncology West Texas
-
Dallas, Texas, 미국, 75390
- 모병
- UT Southwestern Medical Center
-
Dallas, Texas, 미국, 75235
- 모병
- Parkland Health and Hospital System
-
Dallas, Texas, 미국, 75246
- 모병
- Texas Oncology DFW
-
Houston, Texas, 미국, 77030
- 모병
- MD Anderson Cancer Center
-
Round Rock, Texas, 미국, 77845
- 모병
- Baylor Scott & White Medical Center
-
San Antonio, Texas, 미국, 78240
- 모병
- Texas Oncology - San Antonio
-
Temple, Texas, 미국, 76508
- 모병
- Scott And White Memorial Hospital
-
Tyler, Texas, 미국, 75701
- 모병
- UT Health East Texas HOPE Cancer Center
-
-
Virginia
-
Arlington, Virginia, 미국, 22201
- 모병
- Virginia Cancer Specialists
-
Richmond, Virginia, 미국, 23249
- 모병
- Richmond VA Medical Center
-
Richmond, Virginia, 미국, 23298
- 모병
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Lacey, Washington, 미국, 98503
- 모병
- Providence Regional Cancer System
-
Seattle, Washington, 미국, 98109
- 모병
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, 미국, 53226
- 모병
- Medical College Of Wisconsin
-
-
-
-
-
Anderlecht, 벨기에, 1070
- 모병
- Institut Jules Bordet
-
Edegem, 벨기에, 2650
- 모병
- UZ Antwerpen
-
Ghent, 벨기에, 9000
- 완전한
- AZ Maria Middelares
-
Haine Saint Paul La Louviere, 벨기에, 7100
- 모병
- Jolimont
-
Kortrijk, 벨기에, 8500
- 모병
- Az Groeninge
-
Leuven, 벨기에, 3000
- 모병
- Universitair Ziekenhuis Leuven
-
Liège, 벨기에, 4000
- 모병
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
-
-
-
-
-
Barretos, 브라질, 14780 070
- 모병
- Fundacao Pio XII
-
Caxias do Sul, 브라질, 95070 560
- 모병
- Fundacao Universidade de Caxias do Sul
-
Jaú, 브라질, 17210 080
- 모병
- Fundacao Doutor Amaral Carvalho
-
Porto Alegre, 브라질, 91350 200
- 모병
- Hospital Nossa Senhora da Conceicao S A
-
Salvador, 브라질, 40050 410
- 모병
- Hospital Santa Izabel Santa Casa de Misericordia da Bahia
-
São José do Rio Preto, 브라질, 15090-000
- 모병
- Funfarme Sjrp
-
São Paulo, 브라질, 01246 000
- 모병
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
-
São Paulo, 브라질, 01509 900
- 모병
- Fundacao Antonio Prudente A C Camargo Cancer Center
-
São Paulo, 브라질, 05651 900
- 모병
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
-
Vitória, 브라질, 29043 260
- 모병
- Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
-
-
-
-
-
Gothenburg, 스웨덴, 413 45
- 완전한
- Sahlgrenska Universitetssjukhuset
-
Lund, 스웨덴, 222 42
- 모병
- Skanes universitetssjukhus
-
Stockholm, 스웨덴, 171 76
- 모병
- Karolinska Universitetssjukhuset
-
Stockholm, 스웨덴, 118 83
- 모병
- Sodersjukhuset
-
Uppsala, 스웨덴, SE 751 85
- 모병
- Uppsala University
-
-
-
-
-
Badajoz, 스페인, 06006
- 모병
- Hosp. Univ. de Badajoz
-
Barcelona, 스페인, 08028
- 모병
- Hosp. Univ. Quiron Dexeus
-
Barcelona, 스페인, 08003
- 모병
- Hosp. Del Mar
-
Barcelona, 스페인, 08041
- 모병
- Hosp. de La Santa Creu I Sant Pau
-
Barcelona, 스페인, 08035
- 모병
- Hosp Univ Vall D Hebron
-
Madrid, 스페인, 28034
- 모병
- Hosp. Univ. Ramon Y Cajal
-
Madrid, 스페인, 28041
- 모병
- Hosp. Univ. 12 de Octubre
-
Madrid, 스페인, 28007
- 모병
- Hosp. Gral. Univ. Gregorio Maranon
-
Madrid, 스페인, 28040
- 모병
- Hosp Univ Fund Jimenez Diaz
-
Madrid, 스페인, 28002
- 모병
- Hosp San Francisco de Asis
-
Málaga, 스페인, 29010
- 모병
- Hosp Regional Univ de Malaga
-
Pamplona, 스페인, 31008
- 모병
- Clinica Univ. de Navarra
-
Seville, 스페인, 41013
- 모병
- Hosp. Virgen Del Rocio
-
Valencia, 스페인, 46010
- 모병
- Hosp. Clinico Univ. de Valencia
-
-
-
-
-
Birmingham, 영국, B9 5ST
- 모병
- Birmingham Heartlands Hospital
-
Hull, 영국, HU16 5JQ
- 모병
- Castle Hill Hospital
-
Leeds, 영국, LS9 7TF
- 모병
- St James University Hospital
-
London, 영국, EC1A 7BE
- 모병
- St Bartholomew's Hospital
-
London, 영국, SW3 6JJ
- 모병
- Royal Marsden Hospital
-
London, 영국, NW1 2BU
- 모병
- University College Hospital
-
Northwood, 영국, HA6 2RN
- 모병
- Mount Vernon Cancer Centre
-
-
-
-
-
Beer Yaakov, 이스라엘, 70300
- 모병
- Yitzhak Shamir Medical Center
-
Haifa, 이스라엘, 3109601
- 모병
- Rambam Medical Center
-
Jerusalem, 이스라엘, 9112001
- 모병
- Hadassah Medical Center
-
Petah Tikva, 이스라엘, 4941492
- 모병
- Rabin Medical Center
-
Ramat Gan, 이스라엘, 52621
- 모병
- Sheba Medical Center
-
Tel Aviv, 이스라엘, 6423906
- 모병
- Tel Aviv Sourasky Medical Center
-
Tel Aviv, 이스라엘, 69710
- 모병
- Assuta MC
-
-
-
-
-
Catania, 이탈리아, 95122
- 모병
- ARNAS Garibaldi P O Nesima
-
Florence, 이탈리아, 50134
- 모병
- Careggi University Hospital
-
Milan, 이탈리아, 20133
- 모병
- Istituto Dei Tumori Di Milano
-
Novara, 이탈리아, 28100
- 모병
- Fondazione del Piemonte per I Oncologia IRCC Candiolo
-
Padova, 이탈리아, 35128
- 모병
- Istituto Oncologico Veneto - IRCCS
-
Pisa, 이탈리아, 56126
- 모병
- Azienda Ospedaliero Universitaria Pisana
-
Rozzano, 이탈리아, 20089
- 모병
- Istituto Clinico Humanitas
-
Udine, 이탈리아, 33100
- 완전한
- Azienda Sanitaria Universitaria Friuli Centrale ASU FC
-
-
-
-
-
Delhi, 인도, 110085
- 모병
- Rajiv Gandhi Cancer Institute and Research Centre
-
Hyderabad, 인도, 500032
- 모병
- Asian Institute Of Gastroenterology
-
Kolkata, 인도, 700053
- 모병
- B P Poddar Hospital and Medical research Limited
-
Mumbai, 인도, 400012
- 모병
- Tata Memorial Hospital
-
New Delhi, 인도, 110029
- 모병
- Safdarjung Hospital
-
Pune, 인도, 411004
- 모병
- Deenanath Mangeshkar Hospital and Research Centre
-
Varanasi, 인도, 221005
- 모병
- Mahamana Pandit Madan Mohan Malviya Cancer Centre
-
Vellore, 인도, 632004
- 모병
- Christian medical
-
-
-
-
-
Chiba, 일본, 260 0801
- 모병
- Chiba Cancer Center
-
Chūōku, 일본, 104 0045
- 모병
- National Cancer Center Hospital
-
Kashiwa, 일본, 277 8577
- 모병
- National Cancer Center Hospital East
-
Nagoya, 일본, 464-8681
- 모병
- Aichi Cancer Center
-
Osaka, 일본, 541 8567
- 모병
- Osaka International Cancer Institute
-
Osaka, 일본, 540 0006
- 모병
- National Hospital Organization Osaka National Hospital
-
Sakai, 일본, 590 0197
- 모병
- Kindai University Hospital
-
Shizuoka, 일본, 411 8777
- 모병
- Shizuoka Cancer Center
-
Suita, 일본, 565 0871
- 모병
- The University of Osaka Hospital
-
Tokyo, 일본, 135 8550
- 모병
- The Cancer Institute Hospital of JFCR
-
-
-
-
-
Beijing, 중국, 100142
- 모병
- Beijing Cancer Hospital
-
Beijing, 중국, 100034
- 모병
- Peking University First Hospital
-
Beijing, 중국, 100050
- 모병
- Beijing Friendship Hospital Capital Medical University
-
Changchun, 중국, 130021
- 모병
- The First Bethune Hospital of Jilin University
-
Changsha, 중국, 410013
- 모병
- Hunan Cancer hospital
-
Chengdu, 중국, 610041
- 모병
- West China Hospital of Sichuan University
-
Ganzhou, 중국, 341000
- 모병
- Ganzhou Cancer Hospital
-
Guangzhou, 중국, 510655
- 모병
- The Sixth Affiliated Hospital Sun Yat sen University
-
Guangzhou, 중국, 519041
- 모병
- Guangdong Provincial People's Hospital
-
Guangzhou, 중국, 100142
- 모병
- Sun Yat Sen University Cancer Center
-
Hangzhou, 중국, 310022
- 모병
- Zhejiang Cancer Hospital
-
Hangzhou, 중국, 310009
- 모병
- The Second Affiliated Hospital of Zhejiang University
-
Harbin, 중국, 150081
- 모병
- Harbin medical university cancer hospital
-
Huizhou, 중국, 516001
- 모병
- Huizhou Central People's Hospital
-
Lanzhou, 중국, 730050
- 모병
- Gansu Provincial Cancer Hospital
-
Nanchang, 중국, 330006
- 모병
- The First Affiliated Hospital of NanChang University
-
Shanghai, 중국, 200032
- 모병
- Fudan University Shanghai Cancer Center
-
Shenyang, 중국, 110042
- 모병
- Liaoning Cancer Hospital and Institute
-
Tianjin, 중국, 300060
- 모병
- Tianjin Medical University Cancer Institute and Hospital
-
Wuhan, 중국, 430079
- 모병
- Hubei Cancer Hospital
-
-
-
-
-
Bangkok, 태국, 10700
- 모병
- Siriraj Hospital
-
Bangkok, 태국, 10400
- 모병
- Ramathibodi Hospital
-
Chiang Mai, 태국, 50200
- 모병
- Chiang Mai University
-
Songkhla, 태국, 90110
- 모병
- Songklanagarind hospital
-
-
-
-
-
Adana, 터키 (Türkiye), 01060
- 모병
- Adana City Hospital
-
Ankara, 터키 (Türkiye), 06800
- 모병
- Ankara Bilkent Sehir Hastanesi
-
Ankara, 터키 (Türkiye), 06010
- 모병
- Gulhane Egitim ve Arastirma Hastanesi
-
Ankara, 터키 (Türkiye), 06200
- 모병
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
Ankara, 터키 (Türkiye), 06560
- 모병
- Gazi Universitesi Hastanesi
-
Antalya, 터키 (Türkiye), 07025
- 모병
- Memorial Antalya Hospital
-
Edirne, 터키 (Türkiye), 22030
- 모병
- Trakya University Medical Faculty
-
Istanbul, 터키 (Türkiye), 34147
- 모병
- Bakirkoy Training and Research Hospital
-
Istanbul, 터키 (Türkiye), 34899
- 모병
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
-
Konya, 터키 (Türkiye), 42090
- 모병
- Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
-
Sakarya, 터키 (Türkiye), 54290
- 모병
- Sakarya University Training and Research Hospital
-
-
-
-
-
Bialystok, 폴란드, 15 027
- 완전한
- Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
-
Biała Podlaska, 폴란드, 21 500
- 완전한
- Wojewodzki Szpital Specjalistyczny
-
Brzozów, 폴란드, 36 200
- 모병
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
-
Gdansk, 폴란드, 80 214
- 모병
- Uniwersyteckie Centrum Kliniczne
-
Gliwice, 폴란드, 44 100
- 완전한
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
-
Lodz, 폴란드, 93 339
- 모병
- Instytut Centrum Zdrowia Matki Polki
-
Olsztyn, 폴란드, 10 228
- 완전한
- Szpital Kliniczny MSWiA z WMCO
-
Opole, 폴란드, 45 061
- 모병
- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
-
Warsaw, 폴란드, 02 034
- 모병
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
-
-
-
-
-
San Juan, 푸에르토 리코, 00935
- 모병
- Pan American Center for Oncology Trials LLC
-
-
-
-
-
Avignon, 프랑스, 84918
- 모병
- Institut Sainte Catherine
-
Pessac, 프랑스, 33604
- 모병
- Hopital Haut Leveque
-
Poitiers, 프랑스, 86000
- 모병
- CHU De Poitiers
-
-
-
-
-
Eger, 헝가리, 3300
- 완전한
- Markhot Ferenc Oktatokorhaz es Rendelointezet
-
Pécs, 헝가리, 7624
- 완전한
- Pecsi Tudomanyegyetem
-
Szeged, 헝가리, 6720
- 완전한
- Szegedi Tudomanyegyetem
-
-
-
-
-
Concord, 호주, 2139
- 완전한
- Concord Hospital
-
Heidelberg, 호주, 3084
- 모병
- Warringal Private Hospital
-
South Woodville, 호주, 5011
- 모병
- Queen Elizabeth Hospital
-
St Albans, 호주, 3021
- 모병
- Western Health Sunshine Hospital
-
-
-
-
-
Hong Kong, 홍콩
- 모병
- Queen Mary Hospital
-
Shatin, 홍콩
- 모병
- Prince Of Wales Hospital
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
다른 이름들:
Irinotecan will be administered as chemotherapy regimen. |
|
활성 비교기: 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.
다른 이름들:
Cetuximab will be administered.
다른 이름들:
Irinotecan will be administered as chemotherapy regimen. Bevacizumab will be administered.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
기간: 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)
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by BICR
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 부위별 신생물
- 신생물
- 장 질환
- 위장관 신생물
- 소화계 신생물
- 소화기계 질환
- 위장병
- 장 신생물
- 직장 질환
- 결장 질환
- 대장 신생물
- 아미노산, 펩티드 및 단백질
- 단백질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- Camptothecin
- 알칼로이드
- 효소 및 코엔자임
- 항체, 모노클로 날, 인간화
- 항체, 모노클로 날
- 항체
- 면역 글로불린
- 면역 단백질
- 혈액 단백질
- 혈청 글로불린
- 글로불린
- 피리 미딘
- Formyltetrahydrofolates
- 테트라 하이드로 폴 레이트
- 엽산
- Pterins
- Teridines
- 우라실
- 피리 미디 논
- 코엔자임
- 베바시주맙
- 이리노테칸
- 세툭시맙
- 플루오로우라실
- 류코보린
- 레보류코보린
- Amivantamab
기타 연구 ID 번호
기타 연구 ID 번호
- 61186372COR3002
- 2024-513853-66-00 (레지스트리 식별자: EUCT number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .