KRAS/NRAS 및 BRAF 야생형 절제 불가능 또는 전이성 좌측 대장암 참가자의 1차 치료제로서 Amivantamab 및 mFOLFOX6 또는 FOLFIRI 대 Cetuximab 및 mFOLFOX6 또는 FOLFIRI에 대한 연구 (OrigAMI-2)
KRAS/NRAS 및 BRAF 야생형 절제 불가능 또는 전이성 좌측 대장암 참가자의 1차 치료제로서 Amivantamab 및 mFOLFOX6 또는 FOLFIRI와 Cetuximab 및 mFOLFOX6 또는 FOLFIRI를 비교하는 무작위 공개 제3상 연구
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 3단계
확장된 액세스
연락처 및 위치
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Amersfoort, 네덜란드, 3813 TZ
- 모병
- Meander Medisch Centrum
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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, 5022 GC
- 모병
- Elisabeth-TweeSteden Ziekenhuis
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Utrecht, 네덜란드, 3584 CX
- 모병
- UMC Utrecht
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Kaohsiung City, 대만, 83301
- 모병
- Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung City, 대만, 80756
- 모병
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Tainan, 대만, 704
- 모병
- National Cheng Kung University Hospital
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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
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Seoul, 대한민국, 05505
- 모병
- Asan Medical Center
-
Seoul, 대한민국, 03080
- 모병
- Seoul National University Hospital
-
Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
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Seoul, 대한민국, 03722
- 모병
- Severance Hospital Yonsei University Health System
-
Seoul, 대한민국, 06591
- 모병
- The Catholic University of Korea Seoul St Marys Hospital
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-
-
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Berlin, 독일, 13353
- 모병
- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
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Dresden, 독일, 01307
- 모병
- Universitaetsklinikum Carl Gustav Carus TU Dresden
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Essen, 독일, 45147
- 모병
- Essen University Hospital
-
Frankfurt am Main, 독일, 60488
- 모병
- Krankenhaus NorthWest
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Freiburg im Breisgau, 독일, 79110
- 모병
- Praxis fur interdisziplinare Onkologie & Hamatologie GbR
-
Hamburg, 독일, 22763
- 모병
- Asklepios Klinik Altona
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Heidelberg, 독일, 69120
- 모병
- National Center for Tumor Diseases NCT
-
Mainz, 독일, 55131
- 모병
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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Munich, 독일, 81377
- 모병
- Klinikum der Universitaet Muenchen
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Ulm, 독일, 89081
- 모병
- Universitatsklinikum Ulm
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-
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Cheras, 말레이시아, 56000
- 모병
- Hospital Canselor Tuanku Muhriz UKM
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George Town, 말레이시아, 10450
- 모병
- Hospital Pulau Pinang
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Ipoh, 말레이시아, 30450
- 모병
- Hospital Raja Permaisuri Bainun
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Kuala Lumpur, 말레이시아, 59100
- 모병
- University Malaya Medical Centre
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Kuala Lumpur, 말레이시아, 50586
- 모병
- Hospital Kuala Lumpur
-
Kuching, 말레이시아, 93586
- 모병
- Hospital Umum Sarawak
-
Putrajaya, 말레이시아, 62250
- 모병
- National Cancer Institute
-
-
-
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Arizona
-
Gilbert, Arizona, 미국, 85234
- 모병
- Banner MD Anderson Cancer Center
-
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Arkansas
-
Jonesboro, Arkansas, 미국, 72401
- 모병
- St. Bernard's Medical Center
-
Springdale, Arkansas, 미국, 72762
- 모병
- Highlands Oncology Group
-
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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
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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
-
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Colorado
-
Denver, Colorado, 미국, 80218
- 모병
- Rocky Mountain Cancer Centers
-
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Connecticut
-
New Haven, Connecticut, 미국, 06519
- 모병
- Yale University School Of Medicine
-
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District of Columbia
-
Washington D.C., District of Columbia, 미국, 20007
- 모병
- Georgetown Univ Medical Center Lombardi Cancer Center
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Florida
-
Fort Myers, Florida, 미국, 33901
- 모병
- Florida Cancer Specialists South
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Orlando, Florida, 미국, 32804
- 모병
- AdventHealth Medical Group Oncology and Hematology at Orlando
-
St. Petersburg, Florida, 미국, 33701-4553
- 모병
- Florida Cancer Specialists North Region
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West Palm Beach, Florida, 미국, 33401-3406
- 모병
- Florida Cancer Specialists East
-
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Georgia
-
Atlanta, Georgia, 미국, 30303
- 모병
- Grady Memorial Hospital
-
Atlanta, Georgia, 미국, 30322
- 모병
- Winship Cancer Institute Emory University
-
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Illinois
-
Arlington Heights, Illinois, 미국, 60005
- 모병
- Illinois Cancer Specialists
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Peoria, Illinois, 미국, 61615
- 모병
- Illinois CancerCare
-
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Indiana
-
Fort Wayne, Indiana, 미국, 46804
- 모병
- Fort Wayne Medical Oncology & Hematology
-
-
Iowa
-
Iowa City, Iowa, 미국, 52242
- 모병
- University of Iowa Hospital
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Waukee, Iowa, 미국, 50263
- 모병
- Mission Cancer Blood
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Kansas
-
Wichita, Kansas, 미국, 67214
- 모병
- Cancer Center of Kansas
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Louisiana
-
New Orleans, Louisiana, 미국, 70121
- 모병
- Ochsner Clinic Foundation
-
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Maryland
-
Baltimore, Maryland, 미국, 21237
- 모병
- MedStar Franklin Square Medical Center
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Frederick, Maryland, 미국, 21702-4337
- 모병
- Frederick Health Hospital - James M Stockman Cancer Institute
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- 모병
- University of Michigan
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Ann Arbor, Michigan, 미국, 48105
- 모병
- VA Ann Arbor Healthcare System
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Detroit, Michigan, 미국, 48202
- 모병
- Henry Ford Hospital
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Grand Rapids, Michigan, 미국, 49503
- 모병
- Cancer And Hematology Centers of Western Michigan PC
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Mississippi
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Hattiesburg, Mississippi, 미국, 39401
- 모병
- Hattiesburg Clinic
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Missouri
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St Louis, Missouri, 미국, 63110
- 모병
- Washington University School Of Medicine
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Nebraska
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Omaha, Nebraska, 미국, 68130
- 모병
- Nebraska Cancer Specialists Midwest Cancer Center
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Nevada
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Las Vegas, Nevada, 미국, 89169
- 모병
- Comprehensive Cancer Centers of Nevada
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New Jersey
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East Brunswick, New Jersey, 미국, 08816
- 모병
- Astera Cancer Care
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New Brunswick, New Jersey, 미국, 08901
- 모병
- Rutgers Cancer Institute
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New Mexico
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Albuquerque, New Mexico, 미국, 87102
- 모병
- University of New Mexico Cancer Center
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New York
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Mineola, New York, 미국, 11501
- 모병
- Perlmutter Cancer Center at NYU Long Island
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New York, New York, 미국, 10003
- 모병
- Mount Sinai
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New York, New York, 미국, 10032
- 모병
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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New York, New York, 미국, 10016
- 모병
- NYU Langone Medical Center NYU Hematology Associates
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New York, New York, 미국, 10009
- 모병
- Mount Sinai West
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Shirley, New York, 미국, 11967
- 모병
- New York Cancer and Blood Specialists
-
The Bronx, New York, 미국, 10461
- 모병
- Montefiore Einstein Comprehensive Cancer Center
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Williamsville, New York, 미국, 14221
- 모병
- University of Buffalo Kaleida Health Cancer Care
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- 모병
- University of North Carolina at Chapel Hill
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Ohio
-
Canton, Ohio, 미국, 44718
- 모병
- Gabrail Cancer Center
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Cleveland, Ohio, 미국, 44106
- 모병
- University Hospitals Cleveland Medical Center
-
Cleveland, Ohio, 미국, 44195
- 모병
- Taussig Cancer Insititute Cleveland Clinic
-
Cleveland, Ohio, 미국, 44111
- 모병
- Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
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Independence, Ohio, 미국, 44131
- 모병
- Cleveland Clinic Cancer Center Independence Family Health Center
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Mansfield, Ohio, 미국, 44906
- 모병
- Cleveland Clinic Cancer Center Mansfield
-
Mayfield Heights, Ohio, 미국, 44124
- 모병
- Cleveland Clinic Cancer Center Hillcrest Hospital
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Sandusky, Ohio, 미국, 44870
- 모병
- Cleveland Clinic Cancer Centers Sandusky
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Strongsville, Ohio, 미국, 44136
- 모병
- Cleveland Clinic Cancer Center Strongsville
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Warrensville Heights, Ohio, 미국, 44122
- 모병
- Cleveland Clinic Cancer Center South Pointe Hospital
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Wooster, Ohio, 미국, 44691
- 모병
- Wooster Milltown Specialty and Surgery Center
-
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Oregon
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Bend, Oregon, 미국, 97701
- 모병
- St Charles Medical Center
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Portland, Oregon, 미국, 97239
- 모병
- Oregon Health And Science University
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Pennsylvania
-
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
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-
Tennessee
-
Nashville, Tennessee, 미국, 37203
- 모병
- SCRI Oncology Partners
-
-
Texas
-
Abilene, Texas, 미국, 79606
- 모병
- Texas Oncology West Texas
-
Dallas, Texas, 미국, 75246
- 모병
- Texas Oncology DFW
-
Dallas, Texas, 미국, 75390
- 모병
- UT Southwestern
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Houston, Texas, 미국, 77030
- 모병
- MD Anderson Cancer Center
-
Round Rock, Texas, 미국, 78665
- 모병
- Baylor Scott and White Health 1
-
San Antonio, Texas, 미국, 78240
- 모병
- Texas Oncology - San Antonio
-
Temple, Texas, 미국, 76508
- 모병
- Baylor Scott and White Health
-
-
Virginia
-
Arlington, Virginia, 미국, 22201
- 모병
- Virginia Cancer Specialists
-
Fairfax, Virginia, 미국, 22031
- 모병
- Inova Schar Cancer Institute Dept of Fairfax Hospital
-
Richmond, Virginia, 미국, 23249
- 모병
- Richmond VA Medical Center
-
Richmond, Virginia, 미국, 23298
- 모병
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Edmonds, Washington, 미국, 98026
- 모병
- Swedish Cancer Institute Edmonds
-
Issaquah, Washington, 미국, 98029
- 모병
- Swedish Cancer Institute Issaquah
-
Seattle, Washington, 미국, 98104
- 모병
- Swedish Cancer Institute
-
Seattle, Washington, 미국, 98109
- 모병
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Madison, Wisconsin, 미국, 53705
- 모병
- William S. Middleton Memorial VA
-
-
-
-
-
Anderlecht, 벨기에, 1070
- 모병
- Institut Jules Bordet
-
Edegem, 벨기에, 2650
- 모병
- Universitair Ziekenhuis Antwerpen
-
Ghent, 벨기에, 9000
- 모집하지 않고 적극적으로
- AZ Maria Middelares
-
Haine Saint Paul La Louviere, 벨기에, 7100
- 모병
- Hopital de 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
-
Santa Maria, 브라질, 97015 450
- 모병
- Clinica de Hematologia e Oncologia Viver Ltda
-
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 University Hospital
-
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
-
-
-
-
-
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
-
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
-
Cambridge, 영국, CB2 0QQ
- 모병
- Addenbrooke's Hospital
-
Edinburgh, 영국, EH4 2XU
- 모병
- Western General 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, NW1 2BU
- 모병
- University College Hospital
-
Northwood, 영국, HA6 2RN
- 모병
- Mount Vernon Cancer Centre
-
Sutton, 영국, SM2 5PT
- 모병
- Royal Marsden Hospital (Sutton)
-
-
-
-
-
Beer Yaakov, 이스라엘, 70300
- 모병
- Yitzhak Shamir Medical Center
-
Haifa, 이스라엘, 3109601
- 모병
- Rambam Medical Center
-
Jerusalem, 이스라엘, 9112001
- 모병
- Hadassah University Hospita Ein Kerem
-
Petah Tikva, 이스라엘, 4941492
- 모병
- Rabin Medical Center
-
Ramat Gan, 이스라엘, 52621
- 완전한
- Sheba Medical Center
-
Tel Aviv, 이스라엘, 6423906
- 모병
- Tel Aviv Sourasky Medical Center
-
Tel Aviv, 이스라엘, 69710
- 모병
- Assuta MC
-
-
-
-
-
Meldola, 이탈리아, 47014
- 모병
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
-
Milan, 이탈리아, 20133
- 모병
- Istituto Dei Tumori Di Milano
-
Padova, 이탈리아, 35128
- 모병
- Istituto Oncologico Veneto - IRCCS
-
Pisa, 이탈리아, 56126
- 모병
- Azienda Ospedaliero Universitaria Pisana
-
Rozzano, 이탈리아, 20089
- 모병
- Istituto Clinico Humanitas
-
-
-
-
-
Delhi, 인도, 110085
- 모병
- Rajiv Gandhi Cancer Institute and Research Centre
-
Kolkata, 인도, 700053
- 모병
- B P Poddar Hospital and Medical research Limited
-
Mumbai, 인도, 400012
- 모병
- Tata Memorial Hospital
-
Pune, 인도, 411004
- 모병
- Deenanath Mangeshkar Hospital and Research Centre
-
Varanasi, 인도, 221005
- 모병
- Mahamana Pandit Madan Mohan Malviya Cancer Centre
-
-
-
-
-
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
-
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, 100191
- 모병
- Peking University Third Hospital
-
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
-
Guangzhou, 중국, 510655
- 모병
- The Sixth Affiliated Hospital Sun Yat sen University
-
Guangzhou, 중국, 519041
- 모병
- Guangdong Provincial People's Hospital
-
Guangzhou, 중국, 510062
- 모병
- Sun Yat Sen University Cancer Center
-
Hangzhou, 중국, 310009
- 모병
- The Second Affiliated Hospital of Zhejiang University College of Medicine
-
Hangzhou, 중국, 310022
- 모병
- Zhejiang Cancer Hospital
-
Hangzhou, 중국, 310003
- 모병
- The First Affiliated Hospital Zhejiang University College of Medicine
-
Harbin, 중국, 150081
- 모병
- Harbin medical university cancer hospital
-
Huizhou, 중국, 516001
- 모병
- Huizhou Central People's 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
-
Shenzhen, 중국, 518036
- 모병
- Peking University Shenzhen Hospital
-
Sichuan, 중국, 610044
- 모병
- West China Hospital of Sichuan University
-
Taiyuan, 중국, 030001
- 모병
- First Hospital of Shanxi Medical University
-
Tianjin, 중국, 300060
- 모병
- Tianjin Medical University Cancer Institute and Hospital
-
Wuhan, 중국, 430079
- 모병
- Hubei Cancer Hospital
-
-
-
-
Alberta
-
Calgary, Alberta, 캐나다, T2N 5G2
- 모병
- Arthur J E Child Comprehensive Cancer Centre
-
-
Ontario
-
Ottawa, Ontario, 캐나다, K1H 8L6
- 모병
- Ottawa Hospital
-
Toronto, Ontario, 캐나다, M5G1X6
- 모병
- Princess Margaret Cancer Centre
-
-
Quebec
-
Montreal, Quebec, 캐나다, H2X 0C1
- 모병
- Centre de Recherche du CHUM
-
-
-
-
-
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
-
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
- 모병
- 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
- 모병
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
-
Lodz, 폴란드, 93 339
- 완전한
- Instytut Centrum Zdrowia Matki Polki
-
Olsztyn, 폴란드, 10 228
- 모병
- Szpital Kliniczny MSWiA z WMCO
-
Opole, 폴란드, 45 061
- 모병
- SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
-
Warsaw, 폴란드, 02 781
- 모병
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
-
-
-
-
-
Barrio Monacillos, 푸에르토 리코, 00935
- 모병
- Pan American Center for Oncology Trials LLC
-
-
-
-
-
Avignon, 프랑스, 84918
- 모병
- Institut Sainte Catherine
-
Lille, 프랑스, 59000
- 모병
- Hopital Claude Huriez
-
Lyon, 프랑스, 69008
- 모병
- Hopital Prive Jean Mermoz
-
Montpellier, 프랑스, 34298
- 모병
- Institut du Cancer de Montpellier
-
Nantes, 프랑스, 44000
- 모병
- CHU Nantes
-
Paris, 프랑스, 75571
- 모병
- Hopital Saint Antoine
-
Pessac, 프랑스, 33604
- 모병
- Hopital Haut Leveque
-
Poitiers, 프랑스, 86000
- 모병
- CHU De Poitiers
-
Villejuif, 프랑스, 94805
- 모병
- Gustave Roussy
-
-
-
-
-
Budapest, 헝가리, 1082
- 모병
- Semmelweis Egyetem
-
Eger, 헝가리, 3300
- 모병
- Markhot Ferenc Oktatokorhaz es Rendelointezet
-
Pécs, 헝가리, 7624
- 완전한
- Pecsi Tudomanyegyetem
-
Szeged, 헝가리, 6720
- 모병
- Szegedi Tudomanyegyetem
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
- Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available)
- Must agree to the submission of fresh tumor tissue
- Have measurable disease according to RECIST v1.1
- Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (>) 12 months prior to CRC recurrence/metastases
- Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
Exclusion Criteria:
- Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
- Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI
- Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor
- Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm A: Amivantamab in Combination With Chemotherapy
Participants will receive amivantamab in combination with chemotherapy (mFOLFOX6 [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin] or FOLFIRI [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met. |
Amivantamab will be administered.
다른 이름들:
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Oxaliplatin will be administered as chemotherapy regimen. Irinotecan hydrochloride will be administered as chemotherapy regimen. |
|
활성 비교기: Arm B: Cetuximab in Combination With Chemotherapy
Participants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met. |
5-fluorouracil will be administered as chemotherapy regimen. Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen. Oxaliplatin will be administered as chemotherapy regimen. Irinotecan hydrochloride will be administered as chemotherapy regimen. Cetuximab will be administered.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
기간: Up to 4 years and 2 months
|
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v) 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date. |
Up to 4 years and 2 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: Up to 7 Years 3 Months
|
OS is defined as the time from the date of randomization to the date of participant's death due to any cause. Any participant not known to have died at the time of analysis will be censored based on the last recorded date on which the participant was known to be alive. |
Up to 7 Years 3 Months
|
|
Objective Response Rate (ORR) as Assessed by BICR
기간: Up to 7 Years 3 Months
|
ORR is defined as the proportion of randomized participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria. BOR is defined as best response recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent systemic anti cancer therapy or date of curative-intent procedure, whichever occurs first. |
Up to 7 Years 3 Months
|
|
Objective Response Rate (ORR) as Assessed by Investigator
기간: Up to 7 Years 3 Months
|
ORR is defined as the percentage of randomized participants achieving complete CR or PR, as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Progression Free Survival (PFS) as Assessed by Investigator
기간: Up to 7 Years 3 Months
|
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by the investigator. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable disease assessment date. |
Up to 7 Years 3 Months
|
|
Duration of Response (DOR) as Assessed by BICR
기간: Up to 7 Years 3 Months
|
DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by BICR using RECIST v1.1 criteria. |
Up to 7 Years 3 Months
|
|
Duration of Response (DOR) as Assessed Investigator
기간: Up to 7 Years 3 Months
|
DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Time to Response (TTR) as Assessed by BICR
기간: Up to 7 Years 3 Months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by BICR. |
Up to 7 Years 3 Months
|
|
Time to Response as Assessed by Investigator
기간: Up to 7 Years 3 Months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by investigator. |
Up to 7 Years 3 Months
|
|
Progression-free Survival After Subsequent Therapy (PFS2)
기간: Up to 7 Years 3 Months
|
PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first. |
Up to 7 Years 3 Months
|
|
Disease Control Rate (DCR) as Assessed by BICR
기간: Up to 7 Years 3 Months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by BICR using RECIST v1.1 criteria. |
Up to 7 Years 3 Months
|
|
Disease Control Rate (DCR) as Assessed by Investigator
기간: Up to 7 Years 3 Months
|
DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by the investigator. |
Up to 7 Years 3 Months
|
|
Time to Treatment Failure
기간: Up to 7 Years 3 Months
|
Time to treatment failure is defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity, or initiation of new anticancer therapy. |
Up to 7 Years 3 Months
|
|
Curative Resection (R0) Rate
기간: Up to 7 Years 3 Months
|
Curative resection (R0) rate is defined as the proportion of participants from the analysis set who underwent curative-intent surgery, where the residual tumor classification was R0. |
Up to 7 Years 3 Months
|
|
Number of Participants with Adverse Events (AEs) by Severity
기간: Up to 7 Years 3 Months
|
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. AE severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) v5.0. by using the standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE. |
Up to 7 Years 3 Months
|
|
Number of Participants with Abnormalities in Laboratory Values
기간: Up to 7 Years 3 Months
|
Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported. |
Up to 7 Years 3 Months
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
기간: From Baseline up to 7 Years 3 Months
|
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms. |
From Baseline up to 7 Years 3 Months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30
기간: Up to 7 Years 3 Months
|
The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptom. |
Up to 7 Years 3 Months
|
|
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC-QLQ-C29) Score
기간: From Baseline up to 7 Years 3 Months
|
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. |
From Baseline up to 7 Years 3 Months
|
|
Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29
기간: Up to 7 Years 3 Months
|
The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. |
Up to 7 Years 3 Months
|
|
Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score
기간: Up to 7 Years 3 Months
|
The EORTC item 168 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "not at all" to 4 "very much." Higher scores indicate severe side effects. |
Up to 7 Years 3 Months
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
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
- 유기 화학 물질
- 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
- 조정 복합체
- 피리 미딘
- Formyltetrahydrofolates
- 테트라 하이드로 폴 레이트
- 엽산
- Pterins
- Teridines
- 우라실
- 피리 미디 논
- 코엔자임
- 옥살리플라틴
- 이리노테칸
- 세툭시맙
- 플루오로우라실
- 류코보린
- 레보류코보린
- Amivantamab
기타 연구 ID 번호
- 61186372COR3001
- 2024-513852-13-00 (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. .