En undersøgelse til evaluering af sikkerheden og effektiviteten af Pumitamig i kombination med kemoterapi versus Nivolumab i kombination med kemoterapi hos deltagere med tidligere ubehandlet avanceret eller metastatisk gastrisk, gastroøsofageal forbindelse eller esophagealt adenokarcinom
ROSETTA Gastric-204: Et blindet, randomiseret, fase 2/3-studie af Pumitamig i kombination med kemoterapi versus Nivolumab i kombination med kemoterapi hos deltagere med tidligere ubehandlet avanceret eller metastatisk gastrisk, gastroøsofageal junction eller esophageal adenocarcinom
The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: First line of the email MUST contain NCT # and Site #.
Undersøgelse Kontakt Backup
- Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Studiesteder
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- Ikke rekrutterer endnu
- Local Institution - 0300
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Kontakt:
- Site 0300
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Buenos Aires, Argentina, C1431FWO
- Rekruttering
- Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
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Kontakt:
- Julieta Grasselli, Site 0054
- Telefonnummer: 541158826679
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Buenos Aires
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Rekruttering
- Instituto Alexander Fleming
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Kontakt:
- Federico Esteso, Site 0061
- Telefonnummer: 01132218900
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1414
- Rekruttering
- Centro Médico Fleischer
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Kontakt:
- Guillermo Mendez, Site 0069
- Telefonnummer: +5491162691673
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Buenos Aires F.D.
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ABB, Buenos Aires F.D., Argentina, C1199ABB
- Rekruttering
- Hospital Italiano de Buenos Aires
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Kontakt:
- Maria Alicia Verzura, Site 0066
- Telefonnummer: 54111555960279
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New South Wales
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Liverpool, New South Wales, Australien, 2170
- Rekruttering
- Liverpool Hospital
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Kontakt:
- Aflah Roohullah, Site 0176
- Telefonnummer: 0472877240
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Queensland
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Birtinya, Queensland, Australien, 4575
- Rekruttering
- Sunshine Coast University Hospital
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Kontakt:
- Michael Allen, Site 0080
- Telefonnummer: +61752021111
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South Australia
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Elizabeth Vale, South Australia, Australien, 5112
- Rekruttering
- Lyell McEwin Hospital
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Kontakt:
- Anas Alawawdeh, Site 0077
- Telefonnummer: 0881829000
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Victoria
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Clayton, Victoria, Australien, 3168
- Rekruttering
- Monash Health
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Kontakt:
- David Lau, Site 0085
- Telefonnummer: (03)95946666
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Melbourne, Victoria, Australien, 3084
- Rekruttering
- Warringal Medical Centre
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Kontakt:
- Niall Tebbutt, Site 0400
- Telefonnummer: 0410582006
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Western Australia
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Murdoch, Western Australia, Australien, 6150
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- St. John of God Murdoch Hospital
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Kontakt:
- Kynan Feeney, Site 0083
- Telefonnummer: +61894389599
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São José do Rio Preto, Brasilien, 15090-000
- Rekruttering
- Faculdade de Medicina de Sao Jose do Rio Preto
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Kontakt:
- Kathia Abdalla, Site 0221
- Telefonnummer: +551733216638
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Ceará
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Fortaleza, Ceará, Brasilien, 60115-281
- Rekruttering
- Núcleo de Oncologia e Hematologia do Ceará
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Kontakt:
- José Rocha, Site 0208
- Telefonnummer: 85999872264
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30140-085
- Rekruttering
- Centro de Investigação Clínica Ciências Médicas
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Kontakt:
- Gabriela Freitas Chaves, Site 0204
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasilien, 59062-000
- Rekruttering
- Liga Norte Riograndense Contra o Câncer
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Kontakt:
- Sulene Oliveira, Site 0226
- Telefonnummer: 5584991191032
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
- Rekruttering
- Hospital de Clinicas de Porto Alegre
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Kontakt:
- Sergio Azevedo, Site 0210
- Telefonnummer: 351222055700
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Santa Maria, Rio Grande do Sul, Brasilien, 97015-373
- Rekruttering
- Clinica Viver
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Kontakt:
- Luis Carlos Moreira Antunes, Site 0425
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Rekruttering
- Arthur J.E. Child Comprehensive Cancer Centre
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Kontakt:
- Hatim Karachiwala, Site 0088
- Telefonnummer: 587-231-6326
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
- Ikke rekrutterer endnu
- Local Institution - 0119
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Kontakt:
- Site 0119
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Centre
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Kontakt:
- Elena Elimova, Site 0121
- Telefonnummer: 4169464501ext.2520
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- Ikke rekrutterer endnu
- Local Institution - 0175
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Kontakt:
- Site 0175
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7500921
- Ikke rekrutterer endnu
- Local Institution - 0068
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Kontakt:
- Site 0068
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Santiago, Santiago Metropolitan, Chile, 7710007
- Ikke rekrutterer endnu
- Local Institution - 0056
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Kontakt:
- Site 0056
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Santiago, Santiago Metropolitan, Chile, 8420383
- Ikke rekrutterer endnu
- Local Institution - 0055
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Kontakt:
- Site 0055
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Departamento de Nariño
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Pasto, Departamento de Nariño, Colombia, 520001
- Ikke rekrutterer endnu
- Local Institution - 0399
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Kontakt:
- Site 0399
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
- Ikke rekrutterer endnu
- Local Institution - 0398
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Kontakt:
- Site 0398
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Glasgow, Det Forenede Kongerige, G12 0YN
- Ikke rekrutterer endnu
- Local Institution - 0354
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Kontakt:
- Site 0354
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London, Det Forenede Kongerige, SW3 6JJ
- Rekruttering
- Royal Marsden Hospital
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Kontakt:
- Elizabeth Cartwright, Site 0357
- Telefonnummer: 020 7811 8460
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Manchester, Det Forenede Kongerige, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
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Kontakt:
- Wasat Mansoor, Site 0331
- Telefonnummer: 0161 446 8217
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London, City of
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London, London, City of, Det Forenede Kongerige, EC1A 7BE
- Rekruttering
- St Bartholomew's Hospital
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Kontakt:
- Marco Gerlinger, Site 0316
- Telefonnummer: 020 7377 7000
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Oxfordshire
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Oxford, Oxfordshire, Det Forenede Kongerige, OX3 7LJ
- Rekruttering
- Oxford University Hospitals NHS Trust
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Kontakt:
- Elizabeth Smyth, Site 0317
- Telefonnummer: +44 300 304 7777
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Surrey
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Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
- Rekruttering
- The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
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Kontakt:
- Elizabeth Cartwright, Site 0444
- Telefonnummer: 020 7811 8460
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Rekruttering
- Mayo Clinic in Arizona - Phoenix
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Kontakt:
- Mohamad Sonbol, Site 0284
- Telefonnummer: 480-301-8000
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California
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Los Angeles, California, Forenede Stater, 90033
- Rekruttering
- USC/Norris Comprehensive Cancer Center
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Kontakt:
- Syma Iqbal, Site 0437
- Telefonnummer: 310-994-2096
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Orange, California, Forenede Stater, 92868
- Rekruttering
- University of California, Irvine (UCI) Health - UC Irvine Medical Center
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Kontakt:
- Farshid Dayyani, Site 0277
- Telefonnummer: 714-456-5153
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San Francisco, California, Forenede Stater, 94158
- Ikke rekrutterer endnu
- Local Institution - 0428
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Kontakt:
- Site 0428
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Florida
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Fort Myers, Florida, Forenede Stater, 33901
- Rekruttering
- Florida Cancer Specialists - South
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Kontakt:
- Fadi Kayali, Site 0429
- Telefonnummer: 239-274-9930
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Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic in Florida
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Kontakt:
- Conor O'Donnell, Site 0433
- Telefonnummer: 904-953-2000
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St. Petersburg, Florida, Forenede Stater, 33701
- Rekruttering
- Florida Cancer Specialists - North
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Kontakt:
- Muhammad Imam, Site 0430
- Telefonnummer: 000-000-0000
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Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- Moffitt Cancer Center
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Kontakt:
- Allan Lima Pereira, Site 0246
- Telefonnummer: 813-745-4436
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- Rekruttering
- Emory University
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Kontakt:
- Gideon T Dosunmu, Site 0377
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- Ikke rekrutterer endnu
- Local Institution - 0379
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Kontakt:
- Site 0379
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Ikke rekrutterer endnu
- Local Institution - 0268
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Kontakt:
- Site 0268
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Rekruttering
- Mayo Clinic in Rochester, Minnesota
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Kontakt:
- Ben George, Site 0259
- Telefonnummer: 507-284-2511
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Missouri
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Columbia, Missouri, Forenede Stater, 65201
- Rekruttering
- Missouri Cancer Associates
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Kontakt:
- John R. Ogden, Site 0426
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- Rekruttering
- University Of Nebraska Medical Center
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Kontakt:
- Kelsey Klute, Site 0286
- Telefonnummer: 701-471-0277
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New York
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Lake Success, New York, Forenede Stater, 11042
- Rekruttering
- Northwell Health/ RJ Zuckerberg Cancer Center
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Kontakt:
- Nicholas Hornstein, Site 0386
- Telefonnummer: 323-533-7275
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
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Kontakt:
- Yelena Janjigian, Site 0242
- Telefonnummer: 646-888-4186
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Rochester, New York, Forenede Stater, 14642
- Ikke rekrutterer endnu
- Local Institution - 0274
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Kontakt:
- Site 0274
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Rekruttering
- University of North Carolina Medical Center
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Kontakt:
- Brent Hanks, Site 0245
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic
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Kontakt:
- Suneel Kamath, Site 0222
- Telefonnummer: 216-445-6721
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Cleveland, Ohio, Forenede Stater, 44106
- Ikke rekrutterer endnu
- Local Institution - 0443
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Kontakt:
- Site 0443
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Rekruttering
- Oncology Associates Of Oregon, Pc
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Kontakt:
- Marc Uemura, Site 0432
- Telefonnummer: 541-214-8284
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Portland, Oregon, Forenede Stater, 97213-2982
- Rekruttering
- Northwest Cancer Specialists, P.C.
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Kontakt:
- Spencer Shao, Site 0419
- Telefonnummer: 503-528-5005
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- Rekruttering
- UPMC Hillman Cancer Center
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Kontakt:
- Anwaar Saeed, Site 0407
- Telefonnummer: 816-898-9413
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Tennessee Oncology
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Kontakt:
- Brian Grieb, Site 0255
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- SCRI Oncology Partners
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Kontakt:
- Meredith Pelster, Site 0417
- Telefonnummer: 615-986-4366
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Texas
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Amarillo, Texas, Forenede Stater, 79124
- Rekruttering
- Texas Oncology - Amarillo Cancer Center
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Kontakt:
- Anton Melnyk, Site 0423
- Telefonnummer: 325-692-0188
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Austin, Texas, Forenede Stater, 78731
- Rekruttering
- Texas Oncology-Austin Central
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Kontakt:
- Vivian Cline, Site 0416
- Telefonnummer: 512-427-9400
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Beaumont, Texas, Forenede Stater, 77702
- Rekruttering
- Texas Oncology
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Kontakt:
- Pavel Levin, Site 0424
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Denison, Texas, Forenede Stater, 75020
- Rekruttering
- Texas Oncology - Northeast Texas
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Kontakt:
- Amir Faridi, Site 0415
- Telefonnummer: 000-000-0000
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Grapevine, Texas, Forenede Stater, 76051
- Rekruttering
- Texas Oncology - DFW
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Kontakt:
- Ravi Patel, Site 0421
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- University of Texas MD Anderson Cancer Center
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Kontakt:
- Jaffer Ajani, Site 0233
- Telefonnummer: 713-792-2828
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San Antonio, Texas, Forenede Stater, 78240
- Rekruttering
- Texas Oncology - San Antonio
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Kontakt:
- John R. Ogden, Site 0427
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Virginia
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Salem, Virginia, Forenede Stater, 24153
- Rekruttering
- Oncology and Hematology Associates of Southwest Virginia, Inc. - Salem
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Kontakt:
- Mark Kochenderfer, Site 0413
- Telefonnummer: 540-982-0237
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- Rekruttering
- University of Wisconsin Carbone Cancer Center - University Hospital
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Kontakt:
- Nataliya Uboha, Site 0271
- Telefonnummer: 608-265-9966
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-
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Marseille, Frankrig, 13385
- Ikke rekrutterer endnu
- Local Institution - 0060
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Kontakt:
- Site 0060
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Paris, Frankrig, 75015
- Rekruttering
- Hôpital Européen Georges Pompidou
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Kontakt:
- Aziz Zaanan, Site 0049
- Telefonnummer: 33156095064
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Auvergne-Rhône-Alpes
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Lyon Cedex08, Auvergne-Rhône-Alpes, Frankrig, 69373
- Rekruttering
- Centre Leon Berard
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Kontakt:
- Clelia Coutzac, Site 0058
- Telefonnummer: +33478785992
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Finistère
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Brest, Finistère, Frankrig, 29609
- Rekruttering
- CHRU de Brest
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Kontakt:
- Jean-Philippe Metges, Site 0064
- Telefonnummer: 33298223428
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Nord
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Lille, Nord, Frankrig, 59000
- Rekruttering
- Hopital Claude Huriez - CHU de Lille
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Kontakt:
- Anthony Turpin, Site 0051
- Telefonnummer: +33320445461
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Frankrig, 44093
- Rekruttering
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
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Kontakt:
- Yann Touchefeu, Site 0062
- Telefonnummer: 33240083163
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Vienne
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Poitiers, Vienne, Frankrig, 86021
- Rekruttering
- Centre Hospitalier Universitaire de Poitiers
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Kontakt:
- David Tougeron, Site 0046
- Telefonnummer: 33549444951
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Delhi, Indien, 110029
- Ikke rekrutterer endnu
- Local Institution - 0403
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Kontakt:
- Site 0403
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Puducherry, Indien, 605006
- Ikke rekrutterer endnu
- Local Institution - 0302
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Kontakt:
- Site 0302
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Pune, Indien, 411001
- Ikke rekrutterer endnu
- Local Institution - 0310
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Kontakt:
- Site 0310
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Dādra and Nagar Haveli and Damān and Diu
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Nashik, Dādra and Nagar Haveli and Damān and Diu, Indien, 422001
- Ikke rekrutterer endnu
- Local Institution - 0306
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Kontakt:
- Site 0306
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Maharashtra
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Mumbai, Maharashtra, Indien, 400012
- Ikke rekrutterer endnu
- Local Institution - 0305
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Kontakt:
- Site 0305
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Milan, Italien, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Kontakt:
- Filippo Pietrantonio, Site 0163
- Telefonnummer: 390223903807
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Milan, Italien, 20132
- Rekruttering
- Ospedale San Raffaele
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Kontakt:
- Silvia Foti, Site 0171
- Telefonnummer: +390226437615
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Roma, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
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Kontakt:
- Giampaolo Tortora, Site 0170
- Telefonnummer: 390458128116
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Campania
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Naples, Campania, Italien, 80138
- Rekruttering
- AOU della Campania Luigi Vanvitelli
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Kontakt:
- Ferdinando De Vita, Site 0167
- Telefonnummer: 390815666713
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Piedmont
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Turin, Piedmont, Italien, 10126
- Rekruttering
- Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
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Kontakt:
- Massimo Di Maio, Site 0166
- Telefonnummer: +393398188822
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Veneto
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Padova, Veneto, Italien, 35128
- Rekruttering
- Istituto Oncologico Veneto IRCCS
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Kontakt:
- Sara Lonardi, Site 0168
- Telefonnummer: 390498215910
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-
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Gifu, Japan, 501-1194
- Rekruttering
- Gifu University Hospital
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Kontakt:
- Akitaka Makiyama, Site 0006
- Telefonnummer: 000-000-0000
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Minami-Ku, Fukuoka, Japan, 811-1347
- Ikke rekrutterer endnu
- Local Institution - 0002
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Kontakt:
- Site 0002
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Sendai, Japan, 980-8574
- Ikke rekrutterer endnu
- Local Institution - 0024
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Kontakt:
- Site 0024
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center Hospital
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Kontakt:
- Yukiya Narita, Site 0013
- Telefonnummer: 81527626111
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Chiba
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Chiba, Chiba, Japan, 260-8717
- Ikke rekrutterer endnu
- Local Institution - 0014
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Kontakt:
- Site 0014
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Kashiwa, Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
-
Kontakt:
- Kohei Shitara, Site 0033
- Telefonnummer: 81471331111
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- Ikke rekrutterer endnu
- Local Institution - 0012
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Kontakt:
- Site 0012
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Kanagawa
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Yokohama, Kanagawa, Japan, 2418515
- Rekruttering
- Kanagawa cancer center
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Kontakt:
- Hiroki Osumi, Site 0015
- Telefonnummer: 81335700208
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Okayama-ken
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Kurashiki, Okayama-ken, Japan, 710-8602
- Ikke rekrutterer endnu
- Local Institution - 0029
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Kontakt:
- Site 0029
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Osaka
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Osaka, Osaka, Japan, 5418567
- Ikke rekrutterer endnu
- Local Institution - 0004
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Kontakt:
- Site 0004
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Suita, Osaka, Japan, 565-0871
- Rekruttering
- The University of Osaka Hospital
-
Kontakt:
- Noriko Wada, Site 0028
- Telefonnummer: 81668795111
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Takatsuki, Osaka, Japan, 569-8686
- Ikke rekrutterer endnu
- Local Institution - 0376
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Kontakt:
- Site 0376
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-
Shizuoka
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Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
- Rekruttering
- Shizuoka Cancer Center
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Kontakt:
- Takeshi Kawakami, Site 0026
- Telefonnummer: 81559895222
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Tokyo
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Chuo-ku, Tokyo, Japan, 104-0045
- Rekruttering
- National Cancer Center Hospital
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Kontakt:
- Hirokazu Shoji, Site 0003
- Telefonnummer: 81335422511
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Koto-ku, Tokyo, Japan, 135-8550
- Rekruttering
- The Cancer Institute Hospital of JFCR
-
Kontakt:
- Kensei Yamaguchi, Site 0008
- Telefonnummer: 81335200111
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-
-
-
-
Shanghai, Kina, 200032
- Ikke rekrutterer endnu
- Local Institution - 0269
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Kontakt:
- Site 0269
-
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Rekruttering
- Beijing Cancer hospital
-
Kontakt:
- Lin Shen, Site 0418
- Telefonnummer: 13911219511
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Fujian
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Fuzhou, Fujian, Kina, 350014
- Rekruttering
- Fujian Cancer Hospital
-
Kontakt:
- Yigui Chen, Site 0276
- Telefonnummer: 8613509339525
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Guangdong
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Guangzhou, Guangdong, Kina, 510655
- Rekruttering
- The Sixth Affiliated Hospital of Sun Yat-sen University
-
Kontakt:
- Yanhong Deng, Site 0280
- Telefonnummer: 8613925106525
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Guangzhou, Guangdong, Kina, 510000
- Ikke rekrutterer endnu
- Local Institution - 0232
-
Kontakt:
- Site 0232
-
-
Guangxi
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Nanning, Guangxi, Kina, 530200
- Rekruttering
- Guangxi Medical University Affiliated Tumor Hospital
-
Kontakt:
- Yongqiang Li, Site 0231
- Telefonnummer: 13457161928
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150081
- Ikke rekrutterer endnu
- Local Institution - 0237
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Kontakt:
- Site 0237
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Henan
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Weihui, Henan, Kina, 453100
- Ikke rekrutterer endnu
- Local Institution - 0282
-
Kontakt:
- Site 0282
-
Zhengzhou, Henan, Kina, 450008
- Ikke rekrutterer endnu
- Local Institution - 0249
-
Kontakt:
- Site 0249
-
-
Hubei
-
Wuhan, Hubei, Kina, 430079
- Ikke rekrutterer endnu
- Local Institution - 0279
-
Kontakt:
- Site 0279
-
-
Hunan
-
Changsha, Hunan, Kina, 410031
- Ikke rekrutterer endnu
- Local Institution - 0292
-
Kontakt:
- Site 0292
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210009
- Ikke rekrutterer endnu
- Local Institution - 0256
-
Kontakt:
- Site 0256
-
Yangzhou, Jiangsu, Kina, 225001
- Ikke rekrutterer endnu
- Local Institution - 0440
-
Kontakt:
- Site 0440
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- Ikke rekrutterer endnu
- Local Institution - 0409
-
Kontakt:
- Site 0409
-
-
Liaoning
-
Shenyang, Liaoning, Kina, 110042
- Ikke rekrutterer endnu
- Local Institution - 0244
-
Kontakt:
- Site 0244
-
-
Shandong
-
Jinan, Shandong, Kina, 250117
- Ikke rekrutterer endnu
- Local Institution - 0273
-
Kontakt:
- Site 0273
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200120
- Rekruttering
- Shanghai East Hospital
-
Kontakt:
- Yong Gao, Site 0258
- Telefonnummer: 8613310167477
-
-
Shanxi
-
Taiyuan, Shanxi, Kina, 030001
- Ikke rekrutterer endnu
- Local Institution - 0243
-
Kontakt:
- Site 0243
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610041
- Ikke rekrutterer endnu
- Local Institution - 0260
-
Kontakt:
- Site 0260
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300060
- Ikke rekrutterer endnu
- Local Institution - 0248
-
Kontakt:
- Site 0248
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310003
- Ikke rekrutterer endnu
- Local Institution - 0408
-
Kontakt:
- Site 0408
-
Hangzhou, Zhejiang, Kina, 310052
- Ikke rekrutterer endnu
- Local Institution - 0252
-
Kontakt:
- Site 0252
-
-
-
-
DIF
-
Mexico City, DIF, Mexico, 03100
- Ikke rekrutterer endnu
- Local Institution - 0396
-
Kontakt:
- Site 0396
-
-
Mexico City
-
Mexico City, Mexico City, Mexico, 14000
- Ikke rekrutterer endnu
- Local Institution - 0395
-
Kontakt:
- Site 0395
-
Mexico City, Mexico City, Mexico, 14000
- Ikke rekrutterer endnu
- Local Institution - 0397
-
Kontakt:
- Site 0397
-
-
Oaxaca
-
Oaxaca City, Oaxaca, Mexico, 68020
- Ikke rekrutterer endnu
- Local Institution - 0394
-
Kontakt:
- Site 0394
-
-
-
-
-
Jelenia Góra, Polen, 58-506
- Rekruttering
- Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej
-
Kontakt:
- Katarzyna Wozniak, Site 0336
- Telefonnummer: 48502051990
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 03-411
- Rekruttering
- Mazowiecki Szpital Onkologiczny
-
Kontakt:
- Joanna Omyla-Staszewska, Site 0339
- Telefonnummer: 48227661500
-
Warsaw, Masovian Voivodeship, Polen, 02-034
- Rekruttering
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
-
Kontakt:
- Lucjan Wyrwicz, Site 0361
- Telefonnummer: 225709223
-
-
Opole Voivodeship
-
Opole, Opole Voivodeship, Polen, 45-061
- Rekruttering
- SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
-
Kontakt:
- Barbara Radecka, Site 0320
- Telefonnummer: 48502313767
-
-
-
-
-
Cluj-Napoca, Rumænien, 400015
- Rekruttering
- Institutul Oncologic Cluj
-
Kontakt:
- Tudor Ciuleanu, Site 0019
- Telefonnummer: 40745646368
-
Iași, Rumænien, 700106
- Rekruttering
- S.C. Centrul de Oncologie Euroclinic S.R.L.
-
Kontakt:
- Constantin Volovat, Site 0021
- Telefonnummer: 40746110096
-
Iași, Rumænien, 700483
- Rekruttering
- Institutul Regional de Oncologie
-
Kontakt:
- Bogdan Gafton, Site 0005
- Telefonnummer: 40766307558
-
-
Cluj
-
Cluj-Napoca, Cluj, Rumænien, 400162
- Rekruttering
- Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
-
Kontakt:
- Adrian Radu Vidra, Site 0010
- Telefonnummer: +40724251696
-
Florești, Cluj, Rumænien, 407280
- Rekruttering
- SC Radiotherapy Center Cluj SRL
-
Kontakt:
- Andrei Ungureanu, Site 0030
- Telefonnummer: 40742206212
-
-
Dolj
-
Craiova, Dolj, Rumænien, 200542
- Rekruttering
- Centrul de Oncologie "Sfântul Nectarie"
-
Kontakt:
- Michael Schenker, Site 0011
- Telefonnummer: 40727774974
-
-
-
-
-
Madrid, Spanien, 28046
- Rekruttering
- Hospital Universitario La Paz
-
Kontakt:
- Ana Custodio Carretero, Site 0360
- Telefonnummer: 34917277516
-
Madrid, Spanien, 28040
- Rekruttering
- Hospital Clinico San Carlos
-
Kontakt:
- Javier Sastre Valera, Site 0358
- Telefonnummer: 34620944068
-
Madrid, Spanien, 28007
- Rekruttering
- Hospital General Universitario Gregorio Marañon
-
Kontakt:
- Pilar Aitana Calvo Ferrandiz, Site 0389
- Telefonnummer: 34914269519
-
Málaga, Spanien, 29011
- Rekruttering
- H.R.U Málaga - Hospital General
-
Kontakt:
- Inmaculada Ales Diaz, Site 0390
- Telefonnummer: 34951291425
-
-
Barcelona [Barcelona]
-
Barcelona, Barcelona [Barcelona], Spanien, 08035
- Ikke rekrutterer endnu
- Local Institution - 0388
-
Kontakt:
- Site 0388
-
-
Cantabria
-
Santander, Cantabria, Spanien, 39008
- Rekruttering
- Hospital Universitario Marqués de Valdecilla
-
Kontakt:
- Fernando Rivera Herrero, Site 0350
- Telefonnummer: +34654557483
-
-
Navarre
-
Pamplona, Navarre, Spanien, 31009
- Rekruttering
- Complejo Hospitalario de Navarra
-
Kontakt:
- Maria Alsina Maqueda, Site 0391
- Telefonnummer: 0034848422222
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, Spanien, 46010
- Rekruttering
- Hospital Clinico de Valencia
-
Kontakt:
- TANIA FLEITAS, Site 0312
- Telefonnummer: +34961973517
-
-
-
-
Kyǒnggi-do
-
Seongnam, Kyǒnggi-do, Sydkorea, 13620
- Rekruttering
- Seoul National University Bundang Hospital
-
Kontakt:
- Keun-Wook Lee, Site 0034
- Telefonnummer: 821041671676
-
-
Seoul-teukbyeolsi [Seoul]
-
Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 03080
- Rekruttering
- Seoul National University Hospital
-
Kontakt:
- Do-Youn Oh, Site 0027
- Telefonnummer: 82220720701
-
Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Kontakt:
- jeeyun Lee, Site 0001
- Telefonnummer: +82-2-3410-6820
-
Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System
-
Kontakt:
- Sun Young Rha, Site 0020
- Telefonnummer: 82222288050
-
Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 05505
- Rekruttering
- Asan Medical Center
-
Kontakt:
- Min-Hee Ryu, Site 0036
- Telefonnummer: 82230105935
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 06230
- Ikke rekrutterer endnu
- Local Institution - 0111
-
Kontakt:
- Site 0111
-
Edirne, Tyrkiet (Türkiye), 22030
- Ikke rekrutterer endnu
- Local Institution - 0108
-
Kontakt:
- Site 0108
-
Kadiköy/Istanbul, Tyrkiet (Türkiye), 41380
- Ikke rekrutterer endnu
- Local Institution - 0125
-
Kontakt:
- Site 0125
-
Manisa, Tyrkiet (Türkiye), 45030
- Ikke rekrutterer endnu
- Local Institution - 0093
-
Kontakt:
- Site 0093
-
Sakarya, Tyrkiet (Türkiye), 54100
- Ikke rekrutterer endnu
- Local Institution - 0128
-
Kontakt:
- Site 0128
-
-
-
-
-
Berlin, Tyskland, 10117
- Rekruttering
- Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
-
Kontakt:
- Annika Kurreck, Site 0089
- Telefonnummer: +4930450657306
-
Frankfurt, Tyskland, 60488
- Rekruttering
- Krankenhaus Nordwest GmbH
-
Kontakt:
- Thorsten Goetze, Site 0134
- Telefonnummer: 496976014187
-
Hamburg, Tyskland, 20249
- Rekruttering
- Facharztzentrum Eppendorf
-
Kontakt:
- Alexander Stein, Site 0090
- Telefonnummer: 494036035220
-
Heidelberg, Tyskland, 69120
- Rekruttering
- Nationales Centrum Fur Tumorerkrankungen (Nct)
-
Kontakt:
- Georg Haag, Site 0100
- Telefonnummer: 4962215637630
-
Leipzig, Tyskland, 04103
- Ikke rekrutterer endnu
- Local Institution - 0112
-
Kontakt:
- Site 0112
-
Mainz, Tyskland, 55131
- Rekruttering
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
-
Kontakt:
- Markus Moehler, Site 0105
- Telefonnummer: 496131176076
-
Mannheim, Tyskland, 68167
- Rekruttering
- Universitätsmedizin Mannheim
-
Kontakt:
- Ralf-Dieter Hofheinz, Site 0101
- Telefonnummer: +496213832488
-
Ulm, Tyskland, 89081
- Rekruttering
- Universitaetsklinikum Ulm
-
Kontakt:
- Thomas Seufferlein, Site 0117
- Telefonnummer: 4973150044500
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria
- Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.
- Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1 or < 1 status for Phase 2, and document PD-L1 ≥ 1 status for the Phase 3 part of the study.
- Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
- Participants must have measurable disease as defined by RECIST v1.1.
Exclusion Criteria
- Participants must not have untreated known central nervous system (CNS) metastases.
- Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
- Participants must not have evidence of major coagulation disorders (eg, hemophilia).
- Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a stable dose.
- Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.
- Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Arm C
|
Specified dose on specified days
Andre navne:
Specified dose on specified days Specified dose on specified days |
|
Eksperimentel: Arm D
|
Specified dose on specified days Specified dose on specified days Specified dose on specified days |
|
Eksperimentel: Arm A1
|
Specified dose on specified days
Andre navne:
Specified dose on specified days Specified dose on specified days |
|
Eksperimentel: Arm A2
|
Specified dose on specified days
Andre navne:
Specified dose on specified days Specified dose on specified days |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Tidsramme: Up to 2 years after the last participant is randomized
|
Phase 2 |
Up to 2 years after the last participant is randomized
|
|
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
Tidsramme: Up to approximately 33 months
|
Phase 3 |
Up to approximately 33 months
|
|
Overall survival (OS)
Tidsramme: Up to approximately 47 months
|
Phase 3 |
Up to approximately 47 months
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PFS by RECIST v1.1 per investigator assessment
Tidsramme: Up to approximately 33 months
|
Phase 2 |
Up to approximately 33 months
|
|
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Tidsramme: Up to approximately 33 months
|
Phase 2 |
Up to approximately 33 months
|
|
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Tidsramme: Up to approximately 33 months
|
Phase 2 |
Up to approximately 33 months
|
|
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment
Tidsramme: Up to approximately 33 months
|
Phase 2 |
Up to approximately 33 months
|
|
Recommended dose of Pumitamig for Phase 3
Tidsramme: Up to approximately 33 months
|
Phase 2 |
Up to approximately 33 months
|
|
Objective response (OR) by RECIST v1.1 per BICR
Tidsramme: Up to approximately 33 months
|
Phase 3 |
Up to approximately 33 months
|
|
DOR by RECIST v1.1 per BICR
Tidsramme: Up to approximately 33 months
|
Phase 3 |
Up to approximately 33 months
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i maven
- Adenocarcinom i spiserøret
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Nivolumab
- Folfox -protokol
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CA266-0004
- 2025-523263-37 (Anden identifikator: EU CTR)
- U1111-1325-8116 (Anden identifikator: WHO)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
IPD-delingstidsramme
See Plan Description
IPD-delingsadgangskriterier
See Plan Description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .