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

Who is this study for? Chemotherapy and Immunotherapy-Naïve Patients with Locally Advanced or Metastatic Biliary Tract Cancer
What treatments are being studied? Bintrafusp Alfa
Status: Terminated
Location: See all (99) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC

• Participants must have available tumor tissue (primary or metastatic) (archival or fresh biopsies) before the first administration of study treatment

• At least 1 measurable lesion according to RECIST 1.1

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry and at Week 1, Day 1 prior to dosing

• Life expectancy of \>= 12 weeks, as judged by the Investigator

• Adequate hematological function, hepatic function, renal function, coagulation function as defined in the protocol

• Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals

• Other protocol defined inclusion criteria could apply

Locations
United States
Arizona
Ironwood Cancer & Research Centers - Chandler II
Chandler
Banner MD Anderson Cancer Center
Gilbert
Mayo Clinic Arizona
Phoenix
California
Beverly Hills Cancer Center
Beverly Hills
Florida
Mayo Clinic in Florida - Department of Neurology
Jacksonville
Mount Sinai Medical Center
Miami Beach
Kansas
University of Kansas Medical Center Research Institute, Inc. - University of Kansas Cancer Center/Bloch Pavilion
Westwood
Maryland
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore
Minnesota
Mayo Clinic - Rochester
Rochester
Texas
Methodist Transplant Physicians
Dallas
MD Anderson Cancer Center - Unit 429
Houston
Renovatio Clinical - CENTRAL SITE
The Woodlands
Other Locations
Argentina
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
Ciudad Autonoma Buenos Aires
Instituto de Investigaciones Metabolicas (IDIM)
Ciudad Autonoma Buenos Aires
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma Buenos Aires
Centro Oncologico Riojano Integral (CORI)
La Rioja
CEDIT
Salta
Centro Medico San Roque S.R.L.
San Miguel De Tucuman
Fundacion ARS Medica
San Salvador De Jujuy
Australia
Blacktown Hospital - PARENT
Blacktown
Monash Health
Clayton
Epworth Freemasons
Melbourne
Icon Cancer Care South Brisbane
South Brisbane
Brazil
Hospital de Câncer de Barretos - Fundação Pio XII
Barretos
INCA - Instituto Nacional de Câncer
Rio De Janeiro
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Sao Jose Rio Preto
A. C. Camargo Cancer Center
São Paulo
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo
Chile
IC la serena Research
La Serena
Centro de Investigación Clínica Bradford Hill
Santiago
Hospital Clínico Universidad de Chile
Santiago
Prosalud
Santiago
Instituto Clinico Oncologico del Sur (ICOS)
Temuco
China
Beijing Cancer Hospital
Beijing
Beijing Chao Yang Hospital
Beijing
Beijing Friendship Hospital, Capital Medical University
Beijing
West China Hospital, Sichuan University
Chengdu
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou
The Affiliated Hospital of Qingdao University
Qingdao
Fudan University Shanghai Cancer Hospital
Shanghai
The Second Affiliated Hospital of Soochow University
Suzhou
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
France
ICO - Site Paul Papin - service d'oncologie medicale
Angers Cedex 2
Centre Georges François Leclerc - Oncologie Médicale
Dijon Cedex
CHU Lille - Hôpital Claude Huriez
Lille Cedex
ICO - Site René Gauducheau
Saint Herblain
CHU de Toulouse - Hôpital Ranguei
Toulouse Cedex 9
Germany
Vivantes Klinikum Neukoelln - Haematologie und Onkologie
Berlin
Universitaetsklinikum Bonn AoeR - Medizinische Klinik I Gastroenterologie
Bonn
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
Dresden
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Medizinische Klinik I - HCC Ambulanz
Mainz
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Milano
IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi
Padova
Università Campus Bio-Medico di Roma
Roma
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - UOC Oncologia
Verona
Japan
Chiba Cancer Center
Chiba-shi
National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology
Chuo-ku
NHO Kyushu Cancer Center - Dept of Gastroenterology/Hepatology/Pancreatology
Fukuoka-shi
National Cancer Center Hospital East
Kashiwa-shi
Cancer Institute Hospital of JFCR - Dept of Hepato,Biliary and Pancreatic Medicine
Koto-ku
Kyorin University Hospital
Mitaka-shi
Aichi Cancer Center Hospital
Nagoya-shi
Osaka City University Hospital
Osaka-shi
Kindai University Hospital
Osakasayama-shi
Kanagawa Cancer Center
Yokohama-shi
Poland
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
Gliwice
Pratia
Krakow
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warszawa
ETG Zamosc
Zamosc
Republic of Korea
Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)
Daejeon
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Spain
Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia
Barcelona
Hospital Universitari Vall d'Hebron - Dept of Oncology
Barcelona
Hospital San Pedro de Alcantara - Servicio de Oncologia
Caceres
Hospital Universitario Reina Sofia - Dept of Oncology
Cordoba
ICO l´Hospitalet - Hospital Duran i Reynals
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid
Hospital Universitario Clinico San Carlos - Servicio de Oncologia
Madrid
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia
Madrid
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
Valencia
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
Valencia
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan
United Kingdom
The Christie - Dept of Oncology
Manchester
Time Frame
Start Date: 2019-09-20
Completion Date: 2022-11-10
Participants
Target number of participants: 309
Treatments
Experimental: Safety Run-In Part: M7824 + Gemcitabine + Cisplatin
Experimental: Double-blinded Part: M7824 + Gemcitabine + Cisplatin
Placebo_comparator: Double-blinded Part: Placebo + Gemcitabine + Cisplatin
Sponsors
Collaborators: Merck KGaA, Darmstadt, Germany
Leads: EMD Serono Research & Development Institute, Inc.

This content was sourced from clinicaltrials.gov

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