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JOURNAL ONKOLOGIE – STUDIE
FORTITUDE-102

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

Rekrutierend

NCT-Nummer:
NCT05111626

Studienbeginn:
März 2022

Letztes Update:
28.03.2024

Wirkstoff:
Bemarituzumab, Nivolumab, Chemotherapy

Indikation (Clinical Trials):
Adenocarcinoma, Stomach Neoplasms, Esophageal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 261)

Charite - Universitaetsmedizin Berlin, Campus Virchow
13353 Berlin
(Berlin)
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Universitaetsklinikum Dresden
01307 Dresden
(Sachsen)
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Krankenhaus Nordwest GmbH
60488 Frankfurt am Main
(Hessen)
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Haematologisch Onkologische Praxis Eppendorf
20249 Hamburg
(Hamburg)
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Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
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Universitaetsklinikum Schleswig-Holstein
24105 Kiel
(Schleswig-Holstein)
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Universitaetsklinikum Leipzig
04103 Leipzig
(Sachsen)
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Regional Kliniken Holding Klinikum Ludwigsburg
71640 Ludwigsburg
(Baden-Württemberg)
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Johannes Gutenberg Universitaet Mainz
55131 Mainz
(Rheinland-Pfalz)
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Universitaetsmedizin Mannheim
68167 Mannheim
(Baden-Württemberg)
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Klinikum der LMU Muenchen
81377 Muenchen
(Bayern)
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Klinikum rechts der Isar der TUM
81675 Muenchen
(Bayern)
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Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen
72076 Tuebingen
(Baden-Württemberg)
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Universitaetsklinikum Ulm
89081 Ulm
(Baden-Württemberg)
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Klinikum der Stadt Wolfsburg
38440 Wolfsburg
(Niedersachsen)
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The Oncology Institute Clinical Research
90703 Cerritos
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Cancer and Blood Specialty Clinic
90241 Downey
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City of Hope National Medical Center
91010 Duarte
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University of California Los Angeles
90095 Los Angeles
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University of California Irvine
92868 Orange
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Torrance Memorial Physician Network
90277 Redondo Beach
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Translational Research in Oncology - US Inc
90404 Santa Monica
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Translational Research in Oncology US Inc, Trio Central Pharmacy
90404 Santa Monica
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Olive View-University of California in Los Angeles Medical Center
91342 Sylmar
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Presbyterian Intercommunity Hospital Health Whitter Hospital
90602 Whittier
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Yale New Haven Hospital Yale Cancer Center
06520 New Haven
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Florida Cancer Specialists - Fort Myers
33901 Fort Myers
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Mayo Clinic Florida
32224 Jacksonville
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Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
32804 Orlando
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Orlando Health Cancer Institute
32806 Orlando
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Greater Baltimore Medical Center
21204 Baltimore
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Henry Ford Health System
48202 Detroit
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Mayo Clinic Rochester
55905 Rochester
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Summit Medical Group
07932 Florham Park
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Memorial Sloan Kettering Cancer Center
10022 New York
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Stony Brook University Medical Center
11794-7263 Stony Brook
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FirstHealth Cancer Center
28374 Pinehurst
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Gabrail Cancer Center, LLC
44718 Canton
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Providence Portland Medical Center
97213 Portland
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Saint Lukes University Health Network
18104 Allentown
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Medical University of South Carolina, Hollings Cancer Center
29425 Charleston
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The West Clinic, PLLC
38138 Germantown
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Sarah Cannon Research Institute
37203 Nashville
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Texas Oncology - Austin Midtown
78705 Austin
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University of Texas MD Anderson Cancer Center
77030 Houston
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United States Oncology Regulatory Affairs Corporate Office
77380 The Woodlands
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US Oncology Research Investigational Products Center
77380 The Woodlands
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Virginia Oncology Associates
23502 Norfolk
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Northwest Cancer Specialists - Vancouver
98684 Vancouver
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Aurora Health Care Metro Inc
53215 Milwaukee
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Cemic
C1431FWO Ciudad Autonoma de Buenos Aires
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Hospital Italiano de La Plata
1900 La Plata
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Centro Medico Austral
C1019ABS Ciudad Autónoma de Buenos Aires
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Fundacion Ars Medica
4600 San Salvador de Jujuy
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Exelsus Oncologia Clinica
4000 San Miguel de Tucuman
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Fundacion Respirar
C1426ABP Buenos Aires
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C1199ABB Capital Federal
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Hospital Privado Universitario de Cordoba
X5016KEH Córdoba
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Centro Oncologico Riojano Integral
F5300COE La Rioja
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GenesisCare -North Shore Oncology
2065 St Leonards
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Calvary Mater Newcastle Hospital
2298 Waratah
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The Queen Elizabeth Hospital
5011 Woodville South
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Austin Health, Austin Hospital
3084 Heidelberg
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Medizinische Universitaet Innsbruck
6020 Innsbruck
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2700 Wiener Neustadt
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Universitaetsklinikum Allgemeines Krankenhaus Wien
1090 Wien
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Universite Catholique de Louvain Cliniques Universitaires Saint Luc
1200 Bruxelles
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2650 Edegem
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1090 Jette
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3000 Leuven
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Centre Hospitalier Universitaire de Liege - Sart Tilman
4000 Liege
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Algemeen Ziekenhuis Turnhout Campus Sint-Jozef
2300 Turnhout
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Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
60430-230 Fortaleza
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Hospital Evangelico de Cachoeiro de Itapemirim
29308-014 Cachoeiro de Itapemirim
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Personal Oncologia de Precisao e Personalizada
30130-090 Belo Horizonte
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Liga Norte-Riograndense Contra O Cancer
59075-740 Natal
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Hospital das Clinicas de Porto Alegre
90035-003 Porto Alegre
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Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
90110-270 Porto Alegre
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Fundacao Pio 12 Hospital de Amor de Barretos
14784-400 Barretos
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Instituto do Cancer Arnaldo Vieira de Carvalho
01221-020 Sao Paulo
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Sociedade Beneficente de Senhoras Hospital Sirio Libanes
01308-050 Sao Paulo
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Fundacao Antonio Prudente AC Camargo Cancer Center
01508-010 Sao Paulo
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Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
15090-000 São José do Rio Preto
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Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
04501-000 São Paulo
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Complex Oncology Center - Burgas
8000 Burgas
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Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
6300 Haskovo
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Multiprofile Hospital for Active Treatment - Uni Hospital OOD
4500 Panagyurishte
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Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
4000 Plovdiv
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Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
1606 Sofia
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Multiprofile Hospital for Active Treatment Serdika EOOD
1632 Sofia
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London Health Sciences Centre
N6A 5W9 London
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Princess Margaret Cancer Centre
M4G 2C1 Toronto
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Centre Hospitalier de L Universite de Montreal
H2X 3E4 Montréal
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CHU de Quebec Hopital de l Enfant Jesus
G1J 1Z4 Quebec
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Centro De Estudios Clínicos Suecia SpA
7510062 Santiago de Chile
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Centro de Estudios Clinicos SAGA Spa
7500653 Santiago
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Centro de Estudios Clinicos e Investigaciones Medicas CeCim
8330336 Santiago
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The first people's Hospital of Foshan
528000 Foshan
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Sun Yat-sen University Cancer Center
510030 Guangzhou
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Cancer Hospital of Shantou University Medical College
515031 Shantou
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Guangxi Medical University Cancer Hospital
530021 Nanning
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The Second Xiangya Hospital of Central South Universiy
410000 Changsha
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The First People's Hospital of Changzhou
213003 Changzhou
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Zhongda Hospital Southeast University
210009 Nanjing
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Northern Jiangsu Peoples Hospital
225001 Yangzhou
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General Hospital of Ningxia Medical University
750004 Yinchuan
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Shaanxi Provincial Peoples Hospital
710068 Xian
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Affiliated Hospital of Jining Medical University
272007 Jining
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Fakultni nemocnice Hradec Kralove
500 05 Hradec Kralove
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Fakultni nemocnice Kralovske Vinohrady
100 34 Praha 10
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Vseobecna fakultni nemocnice v Praze
128 08 Praha 2
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Fakultni Thomayerova nemocnice
140 59 Praha 4
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Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
80054 Amiens Cedex 1
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Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
25030 Besançon
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Centre Hospitalier Universitaire de Brest
29200 Brest
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Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing
63003 Clermont-Ferrand cedex 1
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Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
59037 Lille
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Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
87042 Limoges Cedex
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Institut Mutualiste Montsouris
75674 Paris Cedex 14
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Hôpital Européen Georges Pompidou
75015 Paris
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Centre Hospitalier Universitaire de Rouen
76031 Rouen Cedex
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Centre Rene Gauducheau - Institut de Cancerologie de l Ouest
44800 Saint Herblain
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Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
42270 Saint Priest en Jarez
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Institut de cancerologie Strasbourg Europe
67065 Strasbourg cedex
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Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
31059 Toulouse Cedex 9
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Prince of Wales Hospital
Shatin, New Territories
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Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
1097 Budapest
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Debreceni Egyetem Klinikai Kozpont
4032 Debrecen
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Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
5000 Szolnok
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Komarom-Esztergom Varmegyei Szent Borbala Korhaz
2800 Tatabanya
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Shaare Zedek Medical Center
9103102 Jerusalem
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Hadassah Ein-Kerem Medical Center
9112001 Jerusalem
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Tel-Aviv Sourasky Medical Center
6423906 Tel Aviv
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Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
60126 Ancona
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Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
24127 Bergamo
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Ente Ospedaliero IRCCS Saverio De Bellis
70013 Castellana Grotte
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Azienda Socio Sanitaria Territoriale di Cremona
26100 Cremona
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Azienda Ospedaliero Universitaria Careggi
50134 Firenze
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Ospedale Policlinico San Martino IRCCS
16132 Genova
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Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
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Azienda Ospedaliero Universitaria Luigi Vanvitelli
80131 Napoli
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Istituto Oncologico Veneto IRCCS
35128 Padova
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Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
56126 Pisa
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Nagoya University Hospital
466-8560 Nagoya-shi
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National Cancer Center Hospital East
277-8577 Kashiwa-shi
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National Hospital Organization Shikoku Cancer Center
791-0280 Matsuyama-shi
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National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka-shi
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Hokkaido University Hospital
060-8648 Sapporo
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Kobe City Medical Center General Hospital
650-0047 Kobe-shi
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Yokohama City University Medical Center
232-0024 Yokohama-shi
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Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
241-8515 Yokohama-shi
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Niigata Cancer Center Hospital
951-8566 Niigata-shi
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Kansai Medical University Hospital
573-1191 Hirakata-shi
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Osaka International Cancer Institute
541-8567 Osaka-shi
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Kindai University Hospital
589-8511 Osakasayama-shi
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Osaka University Hospital
565-0871 Suita-shi
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Saitama Cancer Center
362-0806 Kitaadachi-gun
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National Cancer Center Hospital
104-0045 Chuo-ku
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The Cancer Institute Hospital of Japanese Foundation for Cancer Research
135-8550 Koto-ku
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Kyungpook National University Chilgok Hospital
41404 Daegu
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Chungnam National University Hospital
35015 Daejeon
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Jeonbuk National University Hospital
54907 Jeonju-si, Jeollabuk-do
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Seoul National University Bundang Hospital
13620 Seongnam-si, Gyeonggi-do
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Korea University Anam Hospital
02841 Seoul
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Seoul National University Hospital
03080 Seoul
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Kangbuk Samsung Hospital
03181 Seoul
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Severance Hospital Yonsei University Health System
03722 Seoul
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Asan Medical Center
05505 Seoul
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Samsung Medical Center
06351 Seoul
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The Catholic University of Korea Seoul St Marys Hospital
06591 Seoul
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Korea University Guro Hospital
08308 Seoul
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Beskidzkie Centrum Onkologii Szpital Miejski imienia Jana Pawla Drugiego
43-300 Bielsko-Biala
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Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach
44-102 Gliwice
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Przychodnia Lekarska Komed Roman Karaszewski
62-500 Konin
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20-080 Lublin
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Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
10-228 Olsztyn
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08-110 Siedlce
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71-252 Szczecin
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01-748 Warszawa
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Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
02-034 Warszawa
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MTZ Clinical Research powered by Pratia
02-172 Warszawa
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Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
50-556 Wroclaw
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4835-044 Guimaraes
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Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
1649-035 Lisboa
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Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
4464-513 Matosinhos
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4200-319 Porto
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022328 Bucharest
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400015 Cluj Napoca
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400000 Cluj-Napoca
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Centrul de Oncologie Sf Nectarie SRL
200542 Craiova
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700483 Iasi
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119074 Singapore
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168583 Singapore
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41013 Sevilla
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33011 Oviedo
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39008 Santander
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08035 Barcelona
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08908 Hospitalet de Llobregat
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03203 Elche
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46010 Valencia
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15006 A Coruña
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31008 Pamplona
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28034 Madrid
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28041 Madrid
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1205 Geneve
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8091 Zurich
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Kaohsiung Medical University Chung-Ho Memorial Hospital
80756 Kaohsiung
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40447 Taichung
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National Cheng Kung University Hospital
70403 Tainan
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11217 Taipei
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Maharaj Nakorn Chiang Mai Hospital
50200 Chiang Mai
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57000 Chiang Rai
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90110 Songkhla
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Addenbrookes Hospital
CB2 0QQ Cambridge
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University Hospital Coventry
CV2 2DX Coventry
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DD1 9SY Dundee
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M20 4BX Manchester
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Studien-Informationen

Brief Summary:

The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus

5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.

The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6

or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy

(mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.

Ein-/Ausschlusskriterien

Inclusion Criteria Part 1 and Part 2:

- Adult with unresectable, locally advanced or metastatic (not amenable to curative

therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Measurable disease or non-measurable, but evaluable disease, according to Response

Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)

- Participant has no contraindications to nivolumab and either mFOLFOX6 or CAPOX

chemotherapy as per local prescribing information. Participants in Part 1 must have no

contraindications to mFOLFOX6. Participants in Part 2 with contraindications to

mFOLFOX6 are permitted and may be administered the CAPOX regimen, if no

contraindications for this regimen exist. Participants in Part 2 with

contraindications to CAPOX are permitted and may be administered the mFOLFOX6 regimen,

if no contraindications for this regimen exist

- Adequate organ function as follows:

- Absolute neutrophil count ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior

to the first dose of study treatment

- Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper

limit of normal (ULN) (or < 5 x ULN if liver involvement)

- Total bilirubin <1.5 x ULN (or < 2 x ULN if liver involvement or Gilbert's

disease)

- Part 1 only: Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute

calculated using the formula of Cockcroft and Gault ([140 - Age] × Mass [kg]/[72

× Creatinine mg/dL]) (x 0.85 if female).

- Part 2 only: Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute

calculated using the formula of Cockcroft and Gault ([140 - Age] × Mass [kg]/[72 ×

Creatinine mg/dL]) (x 0.85 if female).

- INR or prothrombin time (PT) < 1.5 × ULN except for participants receiving

anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks

prior to enrollment

Additional Inclusion Criteria Part 2:

- No prior treatment for metastatic or unresectable disease except for a maximum of

1 dose of chemotherapy with or without nivolumab; prior adjuvant, neo-adjuvant, and

peri-operative therapy is allowed, provided it has been completed more than 6 months

prior to the first dose of study treatment

- Fibroblast growth factor receptor 2b (FGFR2b) ≥ 10% 2+/3+ tumor cells (TC) as

determined by centrally performed immunohistochemistry (IHC) testing, based on tumor

sample either archival (obtained within 6 months/180 days prior to signing

pre-screening informed consent) or a fresh biopsy.

Exclusion Criteria:

- Prior treatment with any selective inhibitor of the fibroblast growth factor

(FGF)-FGFR pathway

- Known positive human epidermal growth factor receptor 2 (HER2) status

- Untreated or symptomatic central nervous system disease metastases and leptomeningeal

disease

- Peripheral sensory neuropathy grade 2 or higher

- Clinically significant cardiac disease

- Other malignancy within the last 2 years (exceptions for definitively treated disease)

- Chronic or systemic ophthalmologic disorders

- Major surgery or other investigational study within 28 days prior to randomization

- Palliative radiotherapy within 14 days prior to randomization

- Abnormalities of the cornea that may pose an increased risk of developing a corneal

ulcer

- Active autoimmune disease that has required systemic treatment (except replacement

therapy) within the past 2 years or any other diseases requiring immunosuppressive

therapy while on study

Studien-Rationale

Primary outcome:

1. Part 1: Number of Participants Who Experienced DLTs (Time Frame - 28 days)

2. Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) (Time Frame - Up to 4.5 years)

3. Part 1: Number of Participants Who Experienced One or More Related TEAEs (Time Frame - Up to 4.5 years)

4. Part 1: Number of Participants With Clinically Significant Changes in Vital Signs (Time Frame - Up to 4.5 years)

5. Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity (Time Frame - Up to 4.5 years)

6. Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations (Time Frame - Up to 4.5 years)

7. Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests (Time Frame - Up to 4.5 years)

8. Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Up to 4.5 years)

Secondary outcome:

1. Part 1: Objective Response (OR) (Time Frame - Up to 4.5 years)

2. Part 1: Duration of Response (DoR) (Time Frame - Up to 4.5 years)

3. Part 1: Disease Control Rate (DCR) (Time Frame - Up to 4.5 years)

4. Part 1: Progression Free Survival (PFS) (Time Frame - Up to 4.5 years)

5. Part 1: Overall Survival (Time Frame - Up to 4.5 years)

6. Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab (Time Frame - Day 1 to up to 4.5 years)

7. Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab (Time Frame - Day 1 to up to 4.5 years)

8. Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab (Time Frame - Day 1 to up to 4.5 years)

9. Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation (Time Frame - Day 1 to up to 4.5 years)

10. Part 2: PFS in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Up to 4.5 years)

11. Part 2: OR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Up to 4.5 years)

12. Part 2: Number of Participants Who Experienced One or More TEAEs (Time Frame - Up to 4.5 years)

13. Part 2: Number of Participants With Clinically Significant Changes in Vital Signs (Time Frame - Up to 4.5 years)

14. Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity (Time Frame - Up to 4.5 years)

15. Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests (Time Frame - Up to 4.5 years)

16. Part 2: Overall Survival in All Randomized Participants (Time Frame - Up to 4.5 years)

17. Part 2: PFS in All Randomized Participants (Time Frame - Up to 4.5 years)

18. Part 2: Objective Response Rate (ORR) in All Randomized Participants (Time Frame - Up to 4.5 years)

19. Part 2: DoR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Up to 4.5 years)

20. Part 2: DCR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Up to 4.5 years)

21. Part 2: Mean Score in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Version 3.0 (QLQ-C30) Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Up to 4.5 years)

22. Part 2: Change From Baseline in EORTC QLQ-C30 Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Baseline to up to 4.5 years)

23. Part 2: Mean Score in Stomach Cancer Related Symptoms Measured by EORTC Quality of Life Questionnaire-Stomach 22 (QLQ-STO22) in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Up to 4.5 years)

24. Part 2: Change From Baseline in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Baseline to up to 4.5 years)

25. Part 2: Mean Score of Visual Analogue Scale (VAS) Scores as Measured by EuroQol 5-dimensional (EQ-5D-5L) in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Up to 4.5 years)

26. Part 2: Change From Baseline of VAS Scores as Measured by EQ-5D-5L in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Baseline to up to 4.5 years)

27. Part 2: Time to Deterioration in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Day 1 to up to 4.5 years)

28. Part 2: Time to Deterioration in Health-Related Quality of Life (HRQoL) Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Day 1 to up to 4.5 years)

29. Part 2: Time to Deterioration in Physical Function Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants (Time Frame - Day 1 to up to 4.5 years)

30. Part 2: Cmax of Bemarituzumab (Time Frame - Day 1 to up to 4.5 years)

31. Part 2: Ctrough of Bemarituzumab (Time Frame - Day 1 to up to 4.5 years)

32. Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation (Time Frame - Day 1 to up to 4.5 years)

Studien-Arme

  • Experimental: Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab
    Participants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK).
  • Experimental: Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab
    Participants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle. Or participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle.
  • Placebo Comparator: Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab
    Participants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle. Or participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle.

Geprüfte Regime

  • Bemarituzumab (AMG 552):
    Bemarituzumab will be administered as intravenous (IV) infusion.
  • Nivolumab:
    Nivolumab will be administered as IV infusion.
  • Chemotherapy:
    mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion. OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally.
  • Placebo:
    Placebo will be administered as IV infusion.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer"

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