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Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

Primary Purpose

Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

M7824

Placebo

Gemcitabine

Cisplatin

About this trial

This is an interventional treatment trial for Biliary Tract Cancer focused on measuring Metastatic Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer, Ampullary cancer, M7824, Bintrafusp alfa, Transforming growth factor-beta, Programmed death-ligand 1, INTR@PID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Previous and/or intercurrent cancers
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)
Other protocol defined exclusion criteria could apply

Sites / Locations

Ironwood Cancer & Research Centers - Chandler II
Banner MD Anderson Cancer Center
Mayo Clinic Arizona
Beverly Hills Cancer Center
Mayo Clinic in Florida - Department of Neurology
Mount Sinai Medical Center
University of Kansas Medical Center Research Institute, Inc. - University of Kansas Cancer Center/Bloch Pavilion
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Mayo Clinic - Rochester
Methodist Transplant Physicians
MD Anderson Cancer Center - Unit 429
Renovatio Clinical - CENTRAL SITE
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
Instituto de Investigaciones Metabolicas (IDIM)
Instituto Medico Especializado Alexander Fleming
Centro Oncologico Riojano Integral (CORI)
CEDIT
Centro Medico San Roque S.R.L.
Fundacion ARS Medica
Blacktown Hospital - PARENT
Monash Health
Epworth Freemasons
Icon Cancer Care South Brisbane
INCA - Instituto Nacional de Câncer
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Fundação Faculdade Regional de Medicina de São José do Rio Preto
A. C. Camargo Cancer Center
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
IC la serena Research
Centro de Investigación Clínica Bradford Hill
Hospital Clínico Universidad de Chile
Prosalud
Instituto Clinico Oncologico del Sur (ICOS)
Beijing Cancer Hospital
Beijing Friendship Hospital, Capital Medical University
West China Hospital, Sichuan University
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
The Affiliated Hospital of Qingdao University
Fudan University Shanghai Cancer Hospital
The Second Affiliated Hospital of Soochow University
Tianjin Medical University Cancer Institute & Hospital
Union Hospital Tongji Medical College Huazhong University of Science and Technology
ICO - Site Paul Papin - service d'oncologie medicale
Centre Georges François Leclerc - Oncologie Médicale
CHU Lille - Hôpital Claude Huriez
ICO - Site René Gauducheau
CHU de Toulouse - Hôpital Ranguei
Vivantes Klinikum Neukoelln - Haematologie und Onkologie
Universitaetsklinikum Bonn AoeR - Medizinische Klinik I Gastroenterologie
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
Klinikum der Johann Wolfgang Goethe-Universitaet
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Medizinische Klinik I - HCC Ambulanz
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - UOC Oncologia
Chiba Cancer Center
National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology
NHO Kyushu Cancer Center - Dept of Gastroenterology/Hepatology/Pancreatology
National Cancer Center Hospital East
Cancer Institute Hospital of JFCR - Dept of Hepato,Biliary and Pancreatic Medicine
Kyorin University Hospital
Aichi Cancer Center Hospital
Osaka City University Hospital
Kindai University Hospital
Kanagawa Cancer Center
Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)
Seoul National University Bundang Hospital
Asan Medical Center
Korea University Anam Hospital
Korea University Guro Hospital
Samsung Medical Center
Seoul National University Hospital
Severance Hospital, Yonsei University Health System
The Catholic University of Korea, Seoul St. Mary's Hospital
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
Pratia
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
ETG Zamosc
Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia
Hospital Universitari Vall d'Hebron - Dept of Oncology
Hospital San Pedro de Alcantara - Servicio de Oncologia
Hospital Universitario Reina Sofia - Dept of Oncology
ICO l´Hospitalet - Hospital Duran i Reynals
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Hospital Universitario Clinico San Carlos - Servicio de Oncologia
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
Kaohsiung Chang Gung Memorial Hospital
China Medical University Hospital
Taichung Veterans General Hospital
National Cheng Kung University Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital
Chang Gung Memorial Hospital, Linkou
The Christie - Dept of Oncology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Safety Run-In Part: M7824 + Gemcitabine + Cisplatin

Double-blinded Part: M7824 + Gemcitabine + Cisplatin

Double-blinded Part: Placebo + Gemcitabine + Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)

A DLT is a toxicity related to the study intervention that meets the following criteria as evaluated in the open-label, safety run-in: Grade 3 or 4 Immune-related adverse event (irAE) that needs permanent discontinuation of M7824 treatment; a malignant skin lesion induced by M7824 that is local and can be resected with a negative resection margin is not a DLT; Grade 3 or 4 nonhematologic toxicity other than irAE, A life threatening hematological toxicity (unless clearly attributable to chemotherapy alone), which is hardly medically manageable, including a bleeding event resulting in urgent intervention and admission to an intensive care unit and Grade 5 toxicity.

Double-blind Part: Overall Survival

Overall Survival was defined as the time from study day 1 to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.

Secondary Outcome Measures

Safety Run-in Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs) and Treatment Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs.

Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities

Laboratory investigation included hematology and biochemistry. The number of participants with Grade >=3 laboratory abnormalities were reported. Severity of grade 3 or higher TEAEs were graded using NCI-CTCAE v5.0 toxicity grades, as follows: Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death.

Double-blind Part: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)

Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Double-blind Part: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

Percentage of participants with confirmed objective response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC.

Double-blind Part: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

DOR was defined for participants with objective response, as the time from first documentation of objective response (confirmed Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates.

Durable Response of at Least 6 Months According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

Double-blind Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), Treatment Related TEAEs and Adverse Events of Special Interest (AESIs) According to NCI-CTCAE Version 5.0

AE was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and should be closely followed. For this study, AESIs include the following: Infusion-related reactions including immediate hypersensitivity; Immune-related AEs; Transforming growth factor beta (TGFβ) inhibition mediated skin reactions; Anemia; Bleeding AEs.

Full Information

NCT ID

NCT04066491

First Posted

August 22, 2019

Last Updated

November 14, 2022

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany

1. Study Identification

Unique Protocol Identification Number

NCT04066491

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 Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

September 20, 2019 (Actual)

Primary Completion Date

May 20, 2021 (Actual)

Study Completion Date

November 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer

Keywords

Metastatic Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer, Ampullary cancer, M7824, Bintrafusp alfa, Transforming growth factor-beta, Programmed death-ligand 1, INTR@PID

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

309 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Safety Run-In Part: M7824 + Gemcitabine + Cisplatin

Arm Type

Experimental

Arm Title

Double-blinded Part: M7824 + Gemcitabine + Cisplatin

Arm Type

Experimental

Arm Title

Double-blinded Part: Placebo + Gemcitabine + Cisplatin

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

M7824

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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).

Primary Outcome Measure Information:

Title

Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)

Description

Time Frame

Day 1 up to Day 21 of Cycle 1 (each Cycle is of 21 days)

Title

Double-blind Part: Overall Survival

Description

Overall Survival was defined as the time from study day 1 to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.

Time Frame

Time from study day 1 up to data cutoff (assessed up to 609 days)

Secondary Outcome Measure Information:

Title

Description

Time Frame

Time from first treatment to up to data cutoff (assessed up to 609 days)

Title

Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities

Description

Time Frame

Time from first treatment to up to data cutoff (assessed up to 609 days)

Title

Double-blind Part: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)

Description

Time Frame

Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 609 days

Title

Description

Time Frame

Time from randomization of study drug up to data cut off (assessed up to 609 days)

Title

Double-blind Part: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

Description

Time Frame

From first documented objective response to PD or death due to any cause, assessed approximately up to 609 days

Title

Durable Response of at Least 6 Months According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

Time Frame

Time from first treatment assessed up to 1199 days

Title

Description

Time Frame

Time from first treatment to up to data cutoff (assessed up to 609 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Previous and/or intercurrent cancers 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) Other protocol defined exclusion criteria could apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Responsible

Organizational Affiliation

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Official's Role

Study Director

Facility Information:

Facility Name

Ironwood Cancer & Research Centers - Chandler II

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Banner MD Anderson Cancer Center

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Mayo Clinic Arizona

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Facility Name

Beverly Hills Cancer Center

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Mayo Clinic in Florida - Department of Neurology

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Mount Sinai Medical Center

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

University of Kansas Medical Center Research Institute, Inc. - University of Kansas Cancer Center/Bloch Pavilion

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66216

Country

United States

Facility Name

Sidney Kimmel Comprehensive Cancer Center at John Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Mayo Clinic - Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Methodist Transplant Physicians

City

Dallas

State/Province

Texas

ZIP/Postal Code

75203

Country

United States

Facility Name

MD Anderson Cancer Center - Unit 429

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Renovatio Clinical - CENTRAL SITE

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Instituto de Investigaciones Metabolicas (IDIM)

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Instituto Medico Especializado Alexander Fleming

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Centro Oncologico Riojano Integral (CORI)

City

La Rioja

Country

Argentina

Facility Name

CEDIT

City

Salta

Country

Argentina

Facility Name

Centro Medico San Roque S.R.L.

City

San Miguel de Tucuman

Country

Argentina

Facility Name

Fundacion ARS Medica

City

San Salvador de Jujuy

Country

Argentina

Facility Name

Blacktown Hospital - PARENT

City

Blacktown

Country

Australia

Facility Name

Monash Health

City

Clayton

Country

Australia

Facility Name

Epworth Freemasons

City

Melbourne

Country

Australia

Facility Name

Icon Cancer Care South Brisbane

City

South Brisbane

Country

Australia

Facility Name

INCA - Instituto Nacional de Câncer

City

Rio de Janeiro

Country

Brazil

Facility Name

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

City

Santo André

Country

Brazil

Facility Name

Fundação Faculdade Regional de Medicina de São José do Rio Preto

City

Sao Jose Rio Preto

Country

Brazil

Facility Name

A. C. Camargo Cancer Center

City

São Paulo

Country

Brazil

Facility Name

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

City

São Paulo

Country

Brazil

Facility Name

IC la serena Research

City

La Serena

Country

Chile

Facility Name

Centro de Investigación Clínica Bradford Hill

City

Santiago

Country

Chile

Facility Name

Hospital Clínico Universidad de Chile

City

Santiago

Country

Chile

Facility Name

Prosalud

City

Santiago

Country

Chile

Facility Name

Instituto Clinico Oncologico del Sur (ICOS)

City

Temuco

Country

Chile

Facility Name

Beijing Cancer Hospital

City

Beijing

Country

China

Facility Name

Beijing Friendship Hospital, Capital Medical University

City

Beijing

Country

China

Facility Name

West China Hospital, Sichuan University

City

Chengdu

Country

China

Facility Name

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

City

Hangzhou

Country

China

Facility Name

The Affiliated Hospital of Qingdao University

City

Qingdao

Country

China

Facility Name

Fudan University Shanghai Cancer Hospital

City

Shanghai

Country

China

Facility Name

The Second Affiliated Hospital of Soochow University

City

Suzhou

Country

China

Facility Name

Tianjin Medical University Cancer Institute & Hospital

City

Tianjin

Country

China

Facility Name

Union Hospital Tongji Medical College Huazhong University of Science and Technology

City

Wuhan

Country

China

Facility Name

ICO - Site Paul Papin - service d'oncologie medicale

City

Angers Cedex 2

Country

France

Facility Name

Centre Georges François Leclerc - Oncologie Médicale

City

Dijon cedex

Country

France

Facility Name

CHU Lille - Hôpital Claude Huriez

City

Lille cedex

Country

France

Facility Name

ICO - Site René Gauducheau

City

Saint Herblain

Country

France

Facility Name

CHU de Toulouse - Hôpital Ranguei

City

Toulouse Cedex 9

Country

France

Facility Name

Vivantes Klinikum Neukoelln - Haematologie und Onkologie

City

Berlin

Country

Germany

Facility Name

Universitaetsklinikum Bonn AoeR - Medizinische Klinik I Gastroenterologie

City

Bonn

Country

Germany

Facility Name

Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

City

Dresden

Country

Germany

Facility Name

Klinikum der Johann Wolfgang Goethe-Universitaet

City

Frankfurt

Country

Germany

Facility Name

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Medizinische Klinik I - HCC Ambulanz

City

Mainz

Country

Germany

Facility Name

Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - UOC Oncologia

City

Verona

Country

Italy

Facility Name

Chiba Cancer Center

City

Chiba-shi

Country

Japan

Facility Name

National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology

City

Chuo-ku

Country

Japan

Facility Name

NHO Kyushu Cancer Center - Dept of Gastroenterology/Hepatology/Pancreatology

City

Fukuoka-shi

Country

Japan

Facility Name

National Cancer Center Hospital East

City

Kashiwa-shi

Country

Japan

Facility Name

Cancer Institute Hospital of JFCR - Dept of Hepato,Biliary and Pancreatic Medicine

City

Koto-ku

Country

Japan

Facility Name

Kyorin University Hospital

City

Mitaka-shi

Country

Japan

Facility Name

Aichi Cancer Center Hospital

City

Nagoya-shi

Country

Japan

Facility Name

Osaka City University Hospital

City

Osaka-shi

Country

Japan

Facility Name

Kindai University Hospital

City

Osakasayama-shi

Country

Japan

Facility Name

Kanagawa Cancer Center

City

Yokohama-shi

Country

Japan

Facility Name

Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)

City

Daejeon

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

Country

Korea, Republic of

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Korea University Anam Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Korea University Guro Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul St. Mary's Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

City

Gliwice

Country

Poland

Facility Name

Pratia

City

Krakow

Country

Poland

Facility Name

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

City

Warszawa

Country

Poland

Facility Name

ETG Zamosc

City

Zamosc

Country

Poland

Facility Name

Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia

City

Barcelona

Country

Spain

Facility Name

Hospital Universitari Vall d'Hebron - Dept of Oncology

City

Barcelona

Country

Spain

Facility Name

Hospital San Pedro de Alcantara - Servicio de Oncologia

City

Caceres

Country

Spain

Facility Name

Hospital Universitario Reina Sofia - Dept of Oncology

City

Cordoba

Country

Spain

Facility Name

ICO l´Hospitalet - Hospital Duran i Reynals

City

L'Hospitalet de Llobregat

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

City

Madrid

Country

Spain

Facility Name

Hospital Universitario Clinico San Carlos - Servicio de Oncologia

City

Madrid

Country

Spain

Facility Name

Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

City

Madrid

Country

Spain

Facility Name

Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

City

Valencia

Country

Spain

Facility Name

Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

City

Valencia

Country

Spain

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung

Country

Taiwan

Facility Name

China Medical University Hospital

City

Taichung

Country

Taiwan

Facility Name

Taichung Veterans General Hospital

City

Taichung

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital, Linkou

City

Taoyuan

Country

Taiwan

Facility Name

The Christie - Dept of Oncology

City

Manchester

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

IPD Sharing Time Frame

Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union.

IPD Sharing Access Criteria

Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

IPD Sharing URL

http://bit.ly/IPD21

Citations:

PubMed Identifier

32461347

Citation

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.

Results Reference

result

Links:

URL

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200647_0055

Description

Trial Awareness and Transparency website

URL

https://medical.emdserono.com/en_US/home.html

Description

US Medical Information website, Medical Resources

Learn more about this trial

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

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