Spots Global Cancer Trial Database for Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
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Trial Identification
Brief Title: Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
Official Title: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer
Study ID: NCT04066491
Study Description
Brief Summary: Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer & Research Centers - Chandler II, Chandler, Arizona, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
Beverly Hills Cancer Center, Beverly Hills, California, United States
Mayo Clinic in Florida - Department of Neurology, Jacksonville, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Kansas Medical Center Research Institute, Inc. - University of Kansas Cancer Center/Bloch Pavilion, Westwood, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Methodist Transplant Physicians, Dallas, Texas, United States
MD Anderson Cancer Center - Unit 429, Houston, Texas, United States
Renovatio Clinical - CENTRAL SITE, The Woodlands, Texas, United States
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo, Ciudad Autonoma Buenos Aires, , Argentina
Instituto de Investigaciones Metabolicas (IDIM), Ciudad Autonoma Buenos Aires, , Argentina
Instituto Medico Especializado Alexander Fleming, Ciudad Autonoma Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
CEDIT, Salta, , Argentina
Centro Medico San Roque S.R.L., San Miguel de Tucuman, , Argentina
Fundacion ARS Medica, San Salvador de Jujuy, , Argentina
Blacktown Hospital - PARENT, Blacktown, , Australia
Monash Health, Clayton, , Australia
Epworth Freemasons, Melbourne, , Australia
Icon Cancer Care South Brisbane, South Brisbane, , Australia
Hospital de Câncer de Barretos - Fundação Pio XII, Barretos, , Brazil
INCA - Instituto Nacional de Câncer, Rio de Janeiro, , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André, , Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto, Sao Jose Rio Preto, , Brazil
A. C. Camargo Cancer Center, São Paulo, , Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, São Paulo, , Brazil
IC la serena Research, La Serena, , Chile
Centro de Investigación Clínica Bradford Hill, Santiago, , Chile
Hospital Clínico Universidad de Chile, Santiago, , Chile
Prosalud, Santiago, , Chile
Instituto Clinico Oncologico del Sur (ICOS), Temuco, , Chile
Beijing Cancer Hospital, Beijing, , China
Beijing Chao Yang Hospital, Beijing, , China
Beijing Friendship Hospital, Capital Medical University, Beijing, , China
West China Hospital, Sichuan University, Chengdu, , China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou, , China
The Affiliated Hospital of Qingdao University, Qingdao, , China
Fudan University Shanghai Cancer Hospital, Shanghai, , China
The Second Affiliated Hospital of Soochow University, Suzhou, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China
ICO - Site Paul Papin - service d'oncologie medicale, Angers Cedex 2, , France
Centre Georges François Leclerc - Oncologie Médicale, Dijon cedex, , France
CHU Lille - Hôpital Claude Huriez, Lille cedex, , France
ICO - Site René Gauducheau, Saint Herblain, , France
CHU de Toulouse - Hôpital Ranguei, Toulouse Cedex 9, , France
Vivantes Klinikum Neukoelln - Haematologie und Onkologie, Berlin, , Germany
Universitaetsklinikum Bonn AoeR - Medizinische Klinik I Gastroenterologie, Bonn, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I, Dresden, , Germany
Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Medizinische Klinik I - HCC Ambulanz, Mainz, , Germany
Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Milano, , Italy
IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi, Padova, , Italy
Università Campus Bio-Medico di Roma, Roma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - UOC Oncologia, Verona, , Italy
Chiba Cancer Center, Chiba-shi, , Japan
National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology, Chuo-ku, , Japan
NHO Kyushu Cancer Center - Dept of Gastroenterology/Hepatology/Pancreatology, Fukuoka-shi, , Japan
National Cancer Center Hospital East, Kashiwa-shi, , Japan
Cancer Institute Hospital of JFCR - Dept of Hepato,Biliary and Pancreatic Medicine, Koto-ku, , Japan
Kyorin University Hospital, Mitaka-shi, , Japan
Aichi Cancer Center Hospital, Nagoya-shi, , Japan
Osaka City University Hospital, Osaka-shi, , Japan
Kindai University Hospital, Osakasayama-shi, , Japan
Kanagawa Cancer Center, Yokohama-shi, , Japan
Chungnam National University Hospital - Department of Internal Medicine (Rheumatology), Daejeon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie, Gliwice, , Poland
Pratia, Krakow, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warszawa, , Poland
ETG Zamosc, Zamosc, , Poland
Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia, Barcelona, , Spain
Hospital Universitari Vall d'Hebron - Dept of Oncology, Barcelona, , Spain
Hospital San Pedro de Alcantara - Servicio de Oncologia, Caceres, , Spain
Hospital Universitario Reina Sofia - Dept of Oncology, Cordoba, , Spain
ICO l´Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica, Madrid, , Spain
Hospital Universitario Clinico San Carlos - Servicio de Oncologia, Madrid, , Spain
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica, Valencia, , Spain
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica, Valencia, , Spain
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou, Taoyuan, , Taiwan
The Christie - Dept of Oncology, Manchester, , United Kingdom
Contact Details
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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