Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
NCT ID: NCT04066491
Last Updated: 2023-11-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2/PHASE3
309 participants
INTERVENTIONAL
2019-09-20
2022-11-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)
NCT04203160
Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer
NCT01284413
Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
NCT00304135
Biliary Cancers: EGFR INhibitor, Gemcitabine and Oxaliplatin
NCT00552149
Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer
NCT00123825
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Safety Run-In Part: M7824 + Gemcitabine + Cisplatin
M7824
Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of Complete Response), otherwise until criterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 milligram per meter square (mg/m\^2) and 25 mg/m\^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks.
Gemcitabine
Gemcitabine was received intravenously at a dose of 1000 milligram per meter square (mg/m\^2) on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks (Q3W).
Cisplatin
Cisplatin was received intravenously at a dose of 25 mg/m\^2 on Day 1 and Day 8 of 21-day cycle, for 8 cycles every 3 weeks (Q3W).
Double-blinded Part: M7824 + Gemcitabine + Cisplatin
M7824
Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of Complete Response), otherwise until criterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 milligram per meter square (mg/m\^2) and 25 mg/m\^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks.
Gemcitabine
Gemcitabine was received intravenously at a dose of 1000 milligram per meter square (mg/m\^2) on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks (Q3W).
Cisplatin
Cisplatin was received intravenously at a dose of 25 mg/m\^2 on Day 1 and Day 8 of 21-day cycle, for 8 cycles every 3 weeks (Q3W).
Double-blinded Part: Placebo + Gemcitabine + Cisplatin
Placebo
Participants received intravenous infusion of M7824 matched placebo, once every 3 weeks (Q3W) until 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met.
Gemcitabine
Gemcitabine was received intravenously at a dose of 1000 milligram per meter square (mg/m\^2) on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks (Q3W).
Cisplatin
Cisplatin was received intravenously at a dose of 25 mg/m\^2 on Day 1 and Day 8 of 21-day cycle, for 8 cycles every 3 weeks (Q3W).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
M7824
Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of Complete Response), otherwise until criterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 milligram per meter square (mg/m\^2) and 25 mg/m\^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks.
Placebo
Participants received intravenous infusion of M7824 matched placebo, once every 3 weeks (Q3W) until 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met.
Gemcitabine
Gemcitabine was received intravenously at a dose of 1000 milligram per meter square (mg/m\^2) on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks (Q3W).
Cisplatin
Cisplatin was received intravenously at a dose of 25 mg/m\^2 on Day 1 and Day 8 of 21-day cycle, for 8 cycles every 3 weeks (Q3W).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression
* Participants with symptomatic central nervous system (CNS) metastases
* Significant acute or chronic infection including known history of positive test for human immunodeficiency virus (HIV), active tuberculosis, uncontrolled biliary infection and active bacterial or fungal infection requiring systemic therapy (with the exception of hepatitis B and hepatitis C) requiring systemic therapy at study entry and at Week 1 Day 1 prior to dosing.
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
* History of or concurrent interstitial lung disease
* History of hypersensitivity reactions to bintrafusp alfa, anaphylaxis, or recent (within 5 months) uncontrolled asthma, cardiovascular/cerebrovascular disease
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
* Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 Tucumán, , 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, , France
Centre Georges François Leclerc - Oncologie Médicale
Dijon, , France
CHU Lille - Hôpital Claude Huriez
Lille, , France
ICO - Site René Gauducheau
Saint-Herblain, , France
CHU de Toulouse - Hôpital Ranguei
Toulouse, , 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
Milan, , Italy
IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi
Padua, , 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, , Japan
National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology
Chūōku, , Japan
NHO Kyushu Cancer Center - Dept of Gastroenterology/Hepatology/Pancreatology
Fukuoka, , Japan
National Cancer Center Hospital East
Kashiwa-shi, , Japan
Cancer Institute Hospital of JFCR - Dept of Hepato,Biliary and Pancreatic Medicine
Kōtoku, , Japan
Kyorin University Hospital
Mitaka-shi, , Japan
Aichi Cancer Center Hospital
Nagoya, , Japan
Osaka City University Hospital
Osaka, , Japan
Kindai University Hospital
Osakasayama-shi, , Japan
Kanagawa Cancer Center
Yokohama, , Japan
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
Gliwice, , Poland
Pratia
Krakow, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, , Poland
ETG Zamosc
Zamość, , Poland
Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)
Daejeon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
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
Cáceres, , Spain
Hospital Universitario Reina Sofia - Dept of Oncology
Córdoba, , 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 City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
The Christie - Dept of Oncology
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1):e000564. doi: 10.1136/jitc-2020-000564.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-001992-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS200647_0055
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.