A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Key Inclusion Criteria:
- Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate hematological, liver and kidney function. Measurable or non-measurable, but evaluable disease using RECIST v1.1
- Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by a centrally performed immunohistochemistry tissue test and/or FGFR2 gene amplification as determined by a centrally performed circulating tumor deoxyribonucleic acid (ctDNA) blood based assay
- Candidate for mFOLFOX6 chemotherapy
Key Exclusion Criteria:
- Untreated or symptomatic central nervous system (CNS) metastases
- Clinically significant cardiac disease,
- Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
- Active infection requiring systemic treatment
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
- Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
- Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
- Known positivity for human epidermal growth factor receptor 2 (HER2)
- Women who are pregnant or breastfeeding
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Sites / Locations
- University of Arizona Cancer Center
- The Oncology Institute of Tuscon
- Marin Cancer Care, Inc-California Cancer Care A Medical Group, Inc
- Sutter Medical Group
- UCLA Medical Centre - Santa Monica Hematology and Oncology
- Innovative Clinical Research Institute (ICRI)
- Yale Cancer Center
- Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut
- University of Chicago
- Northwestern Medicine Cancer Center Warrenville
- University of Kansas Medical Center
- Oschsner Clinic Foundation
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- University of Michigan Health System
- Karmanos Cancer Institute
- Josephine Ford Cancer Center-Henry Ford Cancer Center
- Summit Medical Group. Morristown Oncology
- University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)
- Stony Brook Cancer Center
- Westchester Institute For Treatment Of Cancer & Blood Disorders
- UNC- Chapel Hill
- FirstHealth Outpatient Cancer Center
- St. Luke's Physician Group - St. Luke's Cancer Care Associates
- Medical University of South Carolina
- Tennessee Cancer Specialists
- Arlington Cancer Center
- Utah Cancer Specialists (Intermountain Hematology - Oncology Associates) UCS Cancer Center
- Virginia Mason Seattle Main Clinic
- Chris O'brien Lifehouse
- The Townsville Hospital
- Sydney Adventist Hospital
- AZ Sint Jan
- CH de l'Ardenne
- CHC Clinique Saint-Joseph
- CHU UCL Namur, site Godinne
- Anhui Provincial Cancer Hospital
- Shiyan Taihe Hospital
- Wuhan Union Hospital of China
- The 81st Hospital of Chinese PLA
- Beijing Cancer Hospital
- Chinese PLA General Hospital
- The First Hospital of Jilin University
- Sino Japanese Friendship Hospital of Jilin University
- Hunan Cancer Hospital
- Xiangya Hospital of Central South University
- Chongqing Daping Hospital
- Fujian Cancer Hospital
- The First Affiliated Hospital, Zhejiang University
- Sir Run Run Shaw Hospital
- Zhejiang Cancer Hospital
- Harbin Medical University Cancer Hopsital
- Nanton Tumor Hospital
- Shanghai East Hospital
- Fudan University Shanghai Cancer Center
- Ruijin Hospital Affiliated to Shanghai Jiatong University School of Medicine
- Cancer Hospital of Shantou University Medical College
- Liaoning Cancer Hospital
- Fourth Hospital of Hebei Medical University
- The Second Affiliated Hospital of Soochow University
- Tianjin Medical University Cancer Institute and Hospital
- Henan Cancer Hospital
- CHRU Jean MINJOZ
- Chu Morvan - Institut de Cancerologie
- Hopital Nord France Comte - Site Le Mittan
- Polyclinique de Gentilly
- CHU de Saint Etienne
- Centre de Radiotherapie - Clinique Sainte Anne
- Centre Paul Strauss
- Klinik fur Innere Medizin, Shwerpunkt Gastroenterologie, Hamatologie, Onkologie, Nephrologie
- Stadtisches Klinikum Braunschweig
- Krankenhaus Nordwest gGmbH, Institut fur Klinisch-Onkologische Forschung
- Klinikum Ludwigsburg
- Universitatsmedizin Manheim, II. Medizinische Klinik
- Klinikum Ostalb, Stauferklinikum Schwabisch Gmund, Zentrum fur Innere Medizin
- Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik I
- National Institute of Oncology
- Del-Pesti Centrumkorhaz - Orszangos Hematologiai es Infektologiai Intezet, Onkologiai Osztaly
- Sugarterapias es Klinikai Onkologaiai Intezet B-A-Z Megyei Korhaz
- Josa Andras Teaching Hospital
- University of Pecs, Clinic of Oncotherapy
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet
- AOU Ospedall Riuniti Umberto
- AO "S.G. Moscati"
- Centro di Riferimento Oncologico
- Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
- Istituto di Ricovero e Cura a Carattere Scientifico - IRCCS di Candiolo
- Azienda Socio-Sanitaria Territoriale di Cremona
- Azienda Ospedaliero Universitaria Caregg - I S.O.D. Oncologia Medica
- Ospedale Policlinico S. Martino
- Ospedale Generale Mater Salutis" - Azienda ULSS n. 21 di Legnago
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
- Istituto Europeo di Oncologia
- Servizio Oncologia Medica ed Ematologia, AOU dell'Universita
- Fondazione Irccs Policlinico San Matteo
- Azienda Ospedaliera Universitaria Pisana
- Policlinico Universitario Campus Bio-Medico di Roma
- Fondazione IRCSS Casa Sollievo Della Sofferenza
- ASST della Valtellina e dell'Alto Lario - PO di Sondrio
- A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
- Azienda Sanitaria Universitaria Integrata de Udine
- National Cancer Center Hospital East
- Kagawa University Hospital
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
- Hiroshima Citizens Hospital
- St. Marianna University School of Medicine Hospital
- Japan Community Health Care Organization Kyushu Hospital
- The Cancer Institute Hospital of JFCR
- Niigata Cancer Center Hospital
- Hyogo College of Medicine College Hospital
- Osaka General Medical Center
- Osaka Medical College Hospital
- Gangnam Severance Hospital, Yonsei University Health System
- Hallym University Sacred Heart Hospital
- Seoul National University Bundang Hospital
- Ajou University Hospital
- Chonbuk National University Hospital
- Gachon University Gil Medical Center
- Kyungpook National University Chilgok Hospital
- Dong-A University Hospital
- Chungnam National University Hospital (CNUH)
- Korea University Anam Hospital
- Yonsei University Health System
- Kangbuk Samsung Hospital
- Asan Medical Center
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Korea University Guro Hospital
- Seoul National University Hospital
- Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II w Bielsku-Bialej
- Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny
- Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
- SP ZOZ Ministerstwa Spraw Wewnetrznych z Warminsko - Mazurskim Centrum Onkologii
- Europejskie Centrum Zdrowia Otwock Szpital im. F. Chopina
- Lekarz Beata Madej Mruk I Partner. Spolka Partnerska Oddzial nr 1 w Rzesowie
- Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej
- Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Onkologi I Radioterapii
- Centro Hospitalar do Baixo Vouga, EPE
- Hospital de Braga
- Hospital Senhora Da Oliveira EPE
- Centro Hospitalar Universitario do Porto E.P.E
- Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E
- Centro Hospitalar de Entre o Douro e Vouga EPE
- Unidade Local de Saude de Matosinhos EPE
- Institutul Clinic Fundeni - Clinica Pediatrie
- S.C. Medisprof S.R.L
- Institutul Oncologic, Prof. Dr. I. Chiricuta Cluj-Napoca
- Spitalul Clinic Judetean de Urgenta ,,Sf. Apostol Andrei" Constanta, Clinica Oncologie Medicala
- S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala
- SC Oncolab SRL, Oncologie
- S.C. Oncocenter Oncologie Clinica S.R.L
- Complejo Hospitalario Universitario A Coruna
- Hospital Universitario Fundacion Alcorcon
- Hospital del Mar
- Hospital Duran I Reynals - Instituto Catalan de Oncologia
- Hospital de la Santa Creu I Sant Pau
- Hospital General de Catalunya
- Institut Catala d'Oncologia - Hospital Doctor Josep Trueta
- Hospital Universitari Arnau de Vilanova
- Hospital Universitario Fundacion Jimenez Diaz
- Hospital Universitario HM Sanchinarro
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario Puerta de Hierro Majadahonda
- Clinica Universidad de Navarra
- Complejo Hospital De Navarra
- Corporacio Sanitaria Parc Tauli
- Hosptial Universitario Virgen Macarena
- Hospital Universitario Mutua de Terrassa
- China Medical University Hospital
- Faculty of Medicine, Chulalongkorn University
- Chiangrai Prachanukroh Hospital
- Faculty of Medicine, Prince of Sonkla University
- Khon Kaen Hospital
- Lampang Cancer Hospital
- Cukurova University Faculty of Medicine Paediatric Nephrology
- Hacettepe Universitesi Tip Fakultesi
- Ankara Oncology Education and Research Hospital
- Ondokuz Mayis University Medicine Faculty
- Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi
- Uludag Universitesi Tip Fakultesi
- Gaziantep Universitesi Tip Fakultesi, Sahinbey Onkoloji Hastanesi
- Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
- Istanbul Madeniyet Universitesi Tip Fakultesi
- Istanbul University Cerrahpasa Medical Faculty
- Medical Park Izmir Hastanesi
- Ege University Hopsital
- Kocaeli Universitesi Tip Fakultesi
- Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi
- Yuzuncuyil Universitesi Tip Fakultesi
- Ninewells Hospital and Medical School
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Bemarituzumab + mFOLFOX6
Placebo + mFOLFOX6
Participants received 15 mg/kg bemarituzumab administered every 2 weeks (Q2W) with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Participants received placebo for bemarituzumab administered every 2 weeks with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.