Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer (FORTITUDE-102)

A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: Bemarituzumab; Drug: Nivolumab; Other: Placebo; Drug: Chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 528
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Recruiting
    • Fundacion Respirar
  • Capital Federal, Argentina, C1199ABB
    • Recruiting
    • Hospital Italiano
  • Córdoba, Argentina, X5000JHQ
    • Recruiting
    • Sanatorio Allende
  • Córdoba, Argentina, X5016KEH
    • Recruiting
    • Hospital Privado Universitario de Córdoba
  • La Rioja, Argentina, F5300COE
    • Recruiting
    • Centro Oncologico Riojano Integral
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
      • Recruiting
      • Cemic
    • La Plata, Buenos Aires, Argentina, 1900
      • Recruiting
      • Hospital Italiano de La Plata
  • Distrito Federal
    • Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1019ABS
      • Recruiting
      • Centro Medico Austral
  • Jujuy
    • San Salvador de Jujuy, Jujuy, Argentina, 4600
      • Recruiting
      • Fundacion Ars Medica
  • Río Negro
    • Viedma, Río Negro, Argentina, 8500
      • Recruiting
      • Clinica Viedma
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Recruiting
      • Exelsus Oncologia Clinica
• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
      • Recruiting
      • GenesisCare -North Shore Oncology
    • Waratah, New South Wales, Australia, 2298
      • Recruiting
      • Calvary Mater Newcastle Hospital
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • Recruiting
      • The Queen Elizabeth Hospital
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Recruiting
      • Ballarat Health Services
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Austin Health, Austin Hospital
• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medizinische Universitaet Graz
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medizinische Universitaet Innsbruck
  • Rankweil, Austria, 6830
    • Recruiting
    • Landeskrankenhaus Feldkirch
  • Salzburg, Austria, 5020
    • Recruiting
    • Landeskrankenhaus Salzburg
  • Wien, Austria, 1090
    • Recruiting
    • Universitaetsklinikum Allgemeines Krankenhaus Wien
  • Wiener Neustadt, Austria, 2700
    • Recruiting
    • Krankenhaus Wiener Neustadt
• Belgium
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
  • Charleroi, Belgium, 5530
    • Recruiting
    • Grand Hôpital de Charleroi
  • Edegem, Belgium, 2650
    • Recruiting
    • Universitair Ziekenhuis Antwerpen
  • Gent, Belgium, 9000
    • Recruiting
    • Universitair Ziekenhuis Gent
  • Jette, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
  • Libramont, Belgium, 6800
    • Recruiting
    • Hopital De Libramont
  • Liege, Belgium, 4000
    • Recruiting
    • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • Turnhout, Belgium, 2300
    • Recruiting
    • Algemeen Ziekenhuis Turnhout Campus Sint-Jozef
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Recruiting
    • Instituto COI
  • São Paulo, Brazil, 04501-000
    • Recruiting
    • Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-230
      • Recruiting
      • Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 70200-730
      • Recruiting
      • Hospital Sírio Libanês
  • Espírito Santo
    • Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-014
      • Recruiting
      • Hospital Evangelico de Cachoeiro de Itapemirim
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-090
      • Recruiting
      • Personal Oncologia de Precisao e Personalizada
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59075-740
      • Recruiting
      • Liga Norte-Riograndense Contra O Cancer
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
      • Recruiting
      • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
      • Recruiting
      • Hospital das Clinicas de Porto Alegre
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Recruiting
      • Fundacao Pio 12 Hospital de Amor de Barretos
    • Sao Paulo, São Paulo, Brazil, 01221-020
      • Recruiting
      • Instituto do Cancer Arnaldo Vieira de Carvalho
    • Sao Paulo, São Paulo, Brazil, 01308-050
      • Recruiting
      • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
    • Sao Paulo, São Paulo, Brazil, 01508-010
      • Recruiting
      • Fundacao Antonio Prudente AC Camargo Cancer Center
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Recruiting
      • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Recruiting
    • Complex Oncology Center - Burgas
  • Haskovo, Bulgaria, 6300
    • Recruiting
    • Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
  • Panagyurishte, Bulgaria, 4500
    • Recruiting
    • Multiprofile Hospital for Active Treatment - Uni Hospital OOD
  • Plovdiv, Bulgaria, 4000
    • Recruiting
    • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
  • Sofia, Bulgaria, 1606
    • Recruiting
    • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
  • Sofia, Bulgaria, 1632
    • Recruiting
    • Multiprofile Hospital for Active Treatment Serdika EOOD
• Canada
  • Quebec, Canada, G1J 1Z4
    • Recruiting
    • CHU de Quebec Hopital de l Enfant Jesus
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M4G 2C1
      • Recruiting
      • Princess Margaret Cancer Centre
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Recruiting
      • Centre Hospitalier de L Universite de Montreal
• Chile
  • La Serena, Chile, 1720430
    • Recruiting
    • IC La Serena Research
  • Santiago, Chile, 7500653
    • Recruiting
    • Centro de Estudios Clínicos SAGA SpA
  • Santiago, Chile, 7510032
    • Recruiting
    • Oncovida
  • Santiago, Chile, 8241479
    • Recruiting
    • Icegclinic
  • Santiago, Chile, 8330336
    • Recruiting
    • Centro de Estudios Clinicos e Investigaciones Medicas CeCim
  • Santiago
    • Santiago de Chile, Santiago, Chile, 7510062
      • Recruiting
      • Centro De Estudios Clínicos Suecia SpA
  • Valparaíso
    • Viña del Mar, Valparaíso, Chile, 2520598
      • Recruiting
      • Oncocentro APYS
• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • The First People's Hospital of Foshan
    • Guangzhou, Guangdong, China, 510030
      • Recruiting
      • Sun Yat-sen University Cancer Center
    • Shantou, Guangdong, China, 515031
      • Recruiting
      • Cancer Hospital of Shantou University Medical College
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • Guangxi Medical University Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • The Second Xiangya Hospital of Central South Universiy
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Recruiting
      • The First People's Hospital of Changzhou
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital Southeast University
    • Yangzhou, Jiangsu, China, 225001
      • Recruiting
      • Northern Jiangsu Peoples Hospital
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Recruiting
      • General Hospital of Ningxia Medical University
  • Shaanxi
    • Xian, Shaanxi, China, 710068
      • Recruiting
      • Shaanxi Provincial Peoples Hospital
  • Shandong
    • Jining, Shandong, China, 272007
      • Recruiting
      • Affiliated hospital of Jining Medical University
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Recruiting
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czechia, 779 00
    • Recruiting
    • Fakultni Nemocnice Olomouc
  • Praha 10, Czechia, 100 34
    • Recruiting
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 2, Czechia, 128 08
    • Recruiting
    • Vseobecna fakultni nemocnice v Praze
  • Praha 4, Czechia, 140 59
    • Recruiting
    • Fakultni Thomayerova nemocnice
• France
  • Amiens Cedex 1, France, 80054
    • Recruiting
    • Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
  • Besançon, France, 25030
    • Recruiting
    • Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz
  • Bordeaux, France, 33000
    • Recruiting
    • Institut Bergonié
  • Brest, France, 29200
    • Recruiting
    • Centre Hospitalier Universitaire de Brest
  • Clermont-Ferrand cedex 1, France, 63003
    • Recruiting
    • Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing
  • Lille, France, 59037
    • Recruiting
    • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
  • Limoges Cedex, France, 87042
    • Recruiting
    • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
  • Lyon cedex 8, France, 69373
    • Recruiting
    • Centre Léon Bérard
  • Nice, France, 06189
    • Recruiting
    • Centre Antoine Lacassagne
  • Paris, France, 75015
    • Recruiting
    • Hôpital Européen Georges Pompidou
  • Paris Cedex 10, France, 75475
    • Recruiting
    • Hopital Saint Louis
  • Paris Cedex 14, France, 75674
    • Recruiting
    • Institut Mutualiste Montsouris
  • Rouen Cedex, France, 76031
    • Recruiting
    • Centre Hospitalier Universitaire de Rouen
  • Saint Herblain, France, 44800
    • Recruiting
    • Centre Rene Gauducheau - Institut de Cancerologie de l Ouest
  • Saint Priest en Jarez, France, 42270
    • Recruiting
    • Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
  • Strasbourg cedex, France, 67065
    • Recruiting
    • Institut de cancerologie Strasbourg Europe
  • Toulouse Cedex 9, France, 31059
    • Recruiting
    • Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charite - Universitaetsmedizin Berlin, Campus Virchow
  • Dresden, Germany, 01307
    • Recruiting
    • Universitaetsklinikum Dresden
  • Frankfurt am Main, Germany, 60488
    • Recruiting
    • Krankenhaus Nordwest GmbH
  • Hamburg, Germany, 20249
    • Recruiting
    • Haematologisch Onkologische Praxis Eppendorf
  • Hannover, Germany, 30625
    • Recruiting
    • Medizinische Hochschule Hannover
  • Kiel, Germany, 24105
    • Recruiting
    • Universitaetsklinikum Schleswig-Holstein
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitaetsklinikum Leipzig
  • Ludwigsburg, Germany, 71640
    • Recruiting
    • Regional Kliniken Holding Klinikum Ludwigsburg
  • Mainz, Germany, 55131
    • Recruiting
    • Johannes Gutenberg Universitaet Mainz
  • Mannheim, Germany, 68167
    • Recruiting
    • Universitaetsmedizin Mannheim
  • Muenchen, Germany, 81675
    • Recruiting
    • Klinikum rechts der Isar der TUM
  • Muenchen, Germany, 81377
    • Recruiting
    • Klinikum der LMU Muenchen
  • Tuebingen, Germany, 72076
    • Recruiting
    • Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen
  • Ulm, Germany, 89081
    • Recruiting
    • Universitaetsklinikum Ulm
  • Wolfsburg, Germany, 38440
    • Recruiting
    • Klinikum der Stadt Wolfsburg
• Hong Kong
  • Shatin, New Territories, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
• Hungary
  • Budapest, Hungary, 1122
    • Recruiting
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary, 1097
    • Recruiting
    • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  • Budapest, Hungary, 1082
    • Recruiting
    • Semmelweis Egyetem
  • Debrecen, Hungary, 4032
    • Recruiting
    • Debreceni Egyetem Klinikai Kozpont
  • Szolnok, Hungary, 5000
    • Recruiting
    • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
  • Tatabanya, Hungary, 2800
    • Recruiting
    • Komarom-Esztergom Varmegyei Szent Borbala Korhaz
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah Ein-Kerem Medical Center
  • Ramat Gan, Israel, 5262000
    • Recruiting
    • Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel-Aviv Sourasky Medical Center
• Italy
  • Ancona, Italy, 60126
    • Recruiting
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • Bergamo, Italy, 24127
    • Recruiting
    • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • Castellana Grotte, Italy, 70013
    • Recruiting
    • Ente Ospedaliero IRCCS Saverio De Bellis
  • Cremona, Italy, 26100
    • Recruiting
    • Azienda Socio Sanitaria Territoriale di Cremona
  • Firenze, Italy, 50134
    • Recruiting
    • Azienda Ospedaliero Universitaria Careggi
  • Genova, Italy, 16132
    • Recruiting
    • Ospedale Policlinico San Martino IRCCS
  • Milano, Italy, 20133
    • Recruiting
    • Fondazione Irccs Istituto Nazionale Dei Tumori
  • Milano, Italy, 20132
    • Recruiting
    • IRCCS Ospedale San Raffaele
  • Napoli, Italy, 80131
    • Recruiting
    • Azienda Ospedaliero Universitaria Luigi Vanvitelli
  • Padova, Italy, 35128
    • Recruiting
    • Istituto Oncologico Veneto IRCCS
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 466-8560
      • Recruiting
      • Nagoya University Hospital
  • Chiba
    • Chiba-shi, Chiba, Japan, 260-8717
      • Recruiting
      • Chiba Cancer Center
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • Recruiting
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama-shi, Ehime, Japan, 791-0280
      • Recruiting
      • National Hospital Organization Shikoku Cancer Center
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 811-1395
      • Recruiting
      • National Hospital Organization Kyushu Cancer Center
  • Gifu
    • Gifu-shi, Gifu, Japan, 501-1194
      • Recruiting
      • Gifu University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Recruiting
      • Hokkaido University Hospital
  • Hyogo
    • Akashi-shi, Hyogo, Japan, 673-8558
      • Recruiting
      • Hyogo Cancer Center
    • Kobe-shi, Hyogo, Japan, 650-0047
      • Recruiting
      • Kobe City Medical Center General Hospital
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 232-0024
      • Recruiting
      • Yokohama City University Medical Center
    • Yokohama-shi, Kanagawa, Japan, 241-8515
      • Recruiting
      • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
  • Niigata
    • Niigata-shi, Niigata, Japan, 951-8566
      • Recruiting
      • Niigata Cancer Center Hospital
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Recruiting
      • Kansai Medical University Hospital
    • Osaka-shi, Osaka, Japan, 541-8567
      • Recruiting
      • Osaka International Cancer Institute
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Recruiting
      • Kindai University Hospital
    • Suita-shi, Osaka, Japan, 565-0871
      • Recruiting
      • Osaka University Hospital
  • Saitama
    • Kitaadachi-gun, Saitama, Japan, 362-0806
      • Recruiting
      • Saitama Cancer Center
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Recruiting
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • Recruiting
      • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Recruiting
    • Kyungpook National University Chilgok Hospital
  • Daejeon, Korea, Republic of, 35015
    • Recruiting
    • Chungnam National University Hospital
  • Jeonju-si, Jeollabuk-do, Korea, Republic of, 54907
    • Recruiting
    • Jeonbuk National University Hospital
  • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    • Recruiting
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 03181
    • Recruiting
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • The Catholic University of Korea Seoul St Marys Hospital
• Poland
  • Bielsko-Biala, Poland, 43-300
    • Recruiting
    • Beskidzkie Centrum Onkologii Szpital Miejski imienia Jana Pawla Drugiego
  • Gliwice, Poland, 44-102
    • Recruiting
    • Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach
  • Konin, Poland, 62-500
    • Recruiting
    • Przychodnia Lekarska KOMED Roman Karaszewski
  • Lublin, Poland, 20-080
    • Recruiting
    • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Olsztyn, Poland, 10-228
    • Recruiting
    • Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
  • Siedlce, Poland, 08-110
    • Recruiting
    • Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
  • Szczecin, Poland, 71-252
    • Recruiting
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie
  • Warszawa, Poland, 02-172
    • Recruiting
    • MTZ Clinical Research Powered by Pratia
  • Warszawa, Poland, 01-748
    • Recruiting
    • Lux med onkologia sp zoo szpital szamocka
  • Warszawa, Poland, 02-034
    • Recruiting
    • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
  • Wroclaw, Poland, 50-556
    • Terminated
    • Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
• Portugal
  • Braga, Portugal, 4710-243
    • Recruiting
    • Hospital de Braga, EPE
  • Guimaraes, Portugal, 4835-044
    • Recruiting
    • Hospital da Senhora da Oliveira Guimaraes, EPE
  • Lisboa, Portugal, 1649-035
    • Recruiting
    • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
  • Lisboa, Portugal, 1500-650
    • Recruiting
    • Hospital da Luz, SA
  • Matosinhos, Portugal, 4464-513
    • Recruiting
    • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
  • Porto, Portugal, 4200-319
    • Recruiting
    • Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao
  • Porto, Portugal, 4100-180
    • Recruiting
    • Hospital CUF Porto
• Romania
  • Bucharest, Romania, 022328
    • Recruiting
    • Institutul Clinic Fundeni
  • Cluj Napoca, Romania, 400015
    • Recruiting
    • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
  • Cluj-Napoca, Romania, 400000
    • Recruiting
    • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
  • Craiova, Romania, 200542
    • Recruiting
    • Centrul de Oncologie Sf Nectarie SRL
  • Iasi, Romania, 700483
    • Recruiting
    • Institutul Regional de Oncologie Iasi
  • Timisoara, Romania, 300239
    • Recruiting
    • SC Oncomed SRL
• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
  • Singapore, Singapore, 168583
    • Recruiting
    • National Cancer Centre Singapore
• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
  • Andalucía
    • Sevilla, Andalucía, Spain, 41013
      • Recruiting
      • Hospital Universitario Virgen Del Rocio
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Recruiting
      • Hospital Universitario Central de Asturias
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marqués de Valdecilla
  • Cataluña
    • Barcelona, Cataluña, Spain, 08035
      • Recruiting
      • Hospital Universitari Vall d Hebron
    • Barcelona, Cataluña, Spain, 08003
      • Recruiting
      • Hospital Del Mar
    • Hospitalet de Llobregat, Cataluña, Spain, 08908
      • Recruiting
      • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
  • Comunidad Valenciana
    • Elche, Comunidad Valenciana, Spain, 03203
      • Recruiting
      • Hospital General Universitario de Elche
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Recruiting
      • Hospital Clínico Universitario de Valencia
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Recruiting
      • Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Recruiting
      • Hospital Universitario de Navarra
• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Universitaetsspital Basel
  • Geneve, Switzerland, 1205
    • Recruiting
    • Hôpitaux Universitaires de Genève
  • Zurich, Switzerland, 8091
    • Recruiting
    • Universitaetsspital Zuerich
• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital
  • Tainan, Taiwan, 70403
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 11490
    • Recruiting
    • Tri-Service General Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Siriraj Hospital
  • Bangkok, Thailand, 10210
    • Recruiting
    • Chulabhorn Hospital
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Maharaj Nakorn Chiang Mai Hospital
  • Chiang Rai, Thailand, 57000
    • Recruiting
    • Chiangrai Prachanukroh Hospital
  • Songkhla, Thailand, 90110
    • Recruiting
    • Prince of Songkla Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Addenbrookes Hospital
  • Coventry, United Kingdom, CV2 2DX
    • Recruiting
    • University Hospital Coventry
  • Dundee, United Kingdom, DD1 9SY
    • Recruiting
    • Ninewells Hospital and Medical School
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Guys Hospital
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • Christie Hospital
  • Northwood, United Kingdom, HA6 2RN
    • Recruiting
    • Mount Vernon Cancer Centre
  • Torquay, United Kingdom, TQ2 7AA
    • Recruiting
    • Torbay Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic - Arizona
  • California
    • Cerritos, California, United States, 90703
      • Recruiting
      • The Oncology Institute Clinical Research
    • Downey, California, United States, 90241
      • Recruiting
      • Cancer and Blood Specialty Clinic
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope National Medical Center
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles
    • Orange, California, United States, 92868
      • Recruiting
      • University of California Irvine
    • Redondo Beach, California, United States, 90277
      • Recruiting
      • Torrance Memorial Physician Network
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Translational Research in Oncology - US Inc
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Translational Research in Oncology US Inc, Trio Central Pharmacy
    • Sylmar, California, United States, 91342
      • Recruiting
      • Olive View-University of California in Los Angeles Medical Center
    • Whittier, California, United States, 90602
      • Recruiting
      • Presbyterian Intercommunity Hospital Health Whitter Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale New Haven Hospital Yale Cancer Center
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Recruiting
      • Florida Cancer Specialists - Fort Myers
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health Cancer Institute
    • Orlando, Florida, United States, 32804
      • Recruiting
      • Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Recruiting
      • Greater Baltimore Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Recruiting
      • Summit Medical Group
  • New York
    • New York, New York, United States, 10022
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
    • Stony Brook, New York, United States, 11794-7263
      • Recruiting
      • Stony Brook University Medical Center
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Recruiting
      • FirstHealth Cancer Center
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Gabrail Cancer Center, LLC
  • Oregon
    • Portland, Oregon, United States, 97213
      • Recruiting
      • Providence Portland Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Recruiting
      • Saint Lukes University Health Network
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina, Hollings Cancer Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Recruiting
      • The West Clinic, PLLC
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Texas Oncology - Austin Midtown
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center
    • The Woodlands, Texas, United States, 77380
      • Recruiting
      • United States Oncology Regulatory Affairs Corporate Office
    • The Woodlands, Texas, United States, 77380
      • Recruiting
      • US Oncology Research Investigational Products Center
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Oncology Associates
  • Washington
    • Vancouver, Washington, United States, 98684
      • Recruiting
      • Northwest Cancer Specialists - Vancouver
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Recruiting
      • Aurora Health Care Metro Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: Bemarituzumab; Bemarituzumab will be administered as intravenous (IV) infusion.; Other Names: AMG 552; Drug: Nivolumab; Nivolumab will be administered as IV infusion.; Drug: 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.
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.	Drug: Bemarituzumab; Bemarituzumab will be administered as intravenous (IV) infusion.; Other Names: AMG 552; Drug: Nivolumab; Nivolumab will be administered as IV infusion.; Drug: 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 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.	Drug: Nivolumab; Nivolumab will be administered as IV infusion.; Other: Placebo; Placebo will be administered as IV infusion.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)	Up to 4.5 years
Part 1: Number of Participants Who Experienced One or More Related TEAEs	Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Vital Signs	Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity	Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations	Up to 4.5 years
Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests	Up to 4.5 years
Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Up to 4.5 years
Part 1: Number of Participants Who Experienced DLTs	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Part 1: Objective Response (OR)	Up to 4.5 years
Part 1: Duration of Response (DoR)	Up to 4.5 years
Part 1: Disease Control Rate (DCR)	Up to 4.5 years
Part 1: Progression Free Survival (PFS)	Up to 4.5 years
Part 1: Overall Survival	Up to 4.5 years
Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab	Day 1 to up to 4.5 years
Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab	Day 1 to up to 4.5 years
Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab	Day 1 to up to 4.5 years
Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation	Day 1 to up to 4.5 years
Part 2: Number of Participants Who Experienced One or More TEAEs	Up to 4.5 years
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs	Up to 4.5 years
Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity	Up to 4.5 years
Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests	Up to 4.5 years
Part 2: Cmax of Bemarituzumab	Day 1 to up to 4.5 years
Part 2: Ctrough of Bemarituzumab	Day 1 to up to 4.5 years
Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation	Day 1 to up to 4.5 years
Part 2: PFS in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Up to 4.5 years
Part 2: OR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Up to 4.5 years
Part 2: Overall Survival in All Randomized Participants	Up to 4.5 years
Part 2: PFS in All Randomized Participants	Up to 4.5 years
Part 2: Objective Response Rate (ORR) in All Randomized Participants	Up to 4.5 years
Part 2: DoR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Up to 4.5 years
Part 2: DCR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Up to 4.5 years
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	Up to 4.5 years
Part 2: Change From Baseline in EORTC QLQ-C30 Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Baseline to up to 4.5 years
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	Up to 4.5 years
Part 2: Change From Baseline in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Baseline to up to 4.5 years
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	Up to 4.5 years
Part 2: Change From Baseline of VAS Scores as Measured by EQ-5D-5L in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Baseline to up to 4.5 years
Part 2: Time to Deterioration in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Day 1 to up to 4.5 years
Part 2: Time to Deterioration in Health-Related Quality of Life (HRQoL) Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Day 1 to up to 4.5 years
Part 2: Time to Deterioration in Physical Function Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants	Day 1 to up to 4.5 years

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): September 26, 2026

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Nivolumab; Gastric Cancer; Bemarituzumab; AMG 552; 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6); Gastroesophageal Junction Adenocarcinoma; FGFR2b Overexpression; Capecitabine and Oxaliplatin (CAPOX)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Neoplasms; Adenocarcinoma; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Bemarituzumab
• Other Study ID Numbers: 20210098; 2023-505458-16 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No