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M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

Primary Purpose

Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

M7824

About this trial

This is an interventional treatment trial for Biliary Tract Cancer focused on measuring M7824, Bintrafusp alfa (proposed INN), Transforming growth factor-beta, First-line Platinum-Based Chemotherapy, Programmed death-ligand 1, Metastatic Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder cancer

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.
Availability of tumor (primary or metastatic) archival material or fresh biopsies is mandatory
Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy administered for locally advanced or metastatic disease. Only one prior treatment line is allowed
Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
Life expectancy >= 12 weeks as judged by the Investigator
Adequate hematological function defined by white blood cell (WBC) count >= 3 * 10^9/Litre with absolute neutrophil count (ANC) >= 1.5 * 109/Litre, lymphocyte count >= 0.5 * 10^9/Litre, platelet count >=75 * 10^9/Litre, and hemoglobin (Hgb) >= 9 grams/decilitre
Adequate hepatic function defined by a total bilirubin level =< 1.5 * upper limit of normal (ULN), an aspartate aminotransferase (AST) level =< 2.5 * ULN, and an alanine aminotransferase (ALT) level =<2.5 * ULN. For participants with liver involvement in their tumor, AST =< 5.0 * ULN and ALT =< 5.0 * ULN is acceptable
Adequate coagulation function defined as prothrombin time (PT) or international normalized ratio (INR) =< 1.5 * ULN unless the participant is receiving anticoagulant therapy
Albumin >= 3.0 grams/decilitre
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
Adequate renal function defined by either creatinine =< 1.5 * ULN or an estimated creatinine clearance (CCr) > 40 milliliter (mL) per minute (min) according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Ampullary cancer is excluded
Significant acute or chronic infections
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
Interstitial lung disease or its history
Participants who are not eligible for or have not been treated with 1L systemic chemotherapy
Anticancer treatment within 21 days before the start of study intervention
Concurrent treatment with nonpermitted drugs
Prior participation in a M7824 clinical trial
Prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-PD 1, anti PD L1, anti- cytotoxic T-cell lymphocyte-4 (CTLA-4) antibodies.
Pregnancy or breast feeding
Systemic anticancer treatment after failing 1L platinum-based chemotherapy
Other protocol defined exclusion criteria could apply

Sites / Locations

Mayo Clinic Arizona
UCSF Mount Zion Medical Ctr
Mayo Clinic in Florida - Department of Neurology
H. Lee Moffitt Cancer Center and Research Institute, Inc
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Mayo Clinic - Rochester
MD Anderson Cancer Center - Unit
Peking University Cancer Hospital
Affiliated Tumor Hospital of Harbin Medical University
Groupe Hospitalier Sud - Hôpital Haut Lévêque - Service Hepato Gastroentérologie Oncologie Digest
ICO - Site René Gauducheau
Institut Gustave Roussy
Istituto Clinico Humanitas
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Unita' Operativa di Pediatria
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica
National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology
National Cancer Center Hospital East
Kyorin University Hospital - Dept of Oncology
Kindai University Hospital - Dept of Gastroenterology
Kanagawa Cancer Center
Seoul National University Bundang Hospital
Seoul National University Hospital
Severance Hospital, Yonsei University Health System
Asan Medical Center
Samsung Medical Center
Hospital de la Santa Creu i Sant Pau
Hospital Universitari Vall d'Hebron - Dept of Oncology
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia
Chang Gung Memorial Hospital, Linkou
National Cheng Kung University Hospital
National Taiwan University Hospital
St James's University Hospital - Dept of Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

M7824

Arm Description

Outcomes

Primary Outcome Measures

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)

Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). 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.

Secondary Outcome Measures

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 confirmed response, as the time from first documentation of objective response (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 Rate (DRR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

DRR was defined as the percentage of participants with confirmed objective response (CR or PR) with duration of at least 6 months. 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. DRR was determined according to RECIST v1.1 and assessed by IRC.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs)

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. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. AESIs included Infusion-related reactions, Immune-related AEs, Transforming growth factor-beta (TGF-β) inhibition mediated skin AE and anemia.

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

PFS was defined as the time from first administration of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. 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.

Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator

Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (Complete Response [CR] or Partial Rresponse [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 Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and assessed by Investigator. Results were calculated based on Kaplan-Meier estimates.

Durable Response Rate (DRR) Acoording to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator

Overall Survival (OS)

OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method.

Serum Pre-Dose Concentrations (Ctrough) of M7824

Ctrough was defined as the concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration for multiple dosing).

Serum Concentration at End of Infusion (CEOI) of M7824

Serum Concentration at End of Infusion (CEOI) of M7824 is reported.

Number of Participants With Positive Antidrug Antibodies (ADA)

Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.

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) According to Programmed Death Ligand 1 (PD-L1) Expression

Percentage of Participants With Confirmed Objective Response as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) According to Microsatellite Instability (MSI) Status

Confirmed OR was defined as the percentage of participants with a confirmed OR of CR or PR. 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 OR was determined according to RECIST v1.1 and as adjudicated by IRC through MSI Status subgroups as:- MSI High = if participant is MSI High for any (at least one) test;- Microsatellite stable (MSS) or MSI Low = if participant is not MSI High for any test;- Unknown (missing) = no MSI tests available at baseline was reported. MSI high: if 2 or more unstable markers were detected in sample; MSI low: if 1 marker was unstable and remaining markers were stable and MSS if all markers were stable.

Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (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 as adjudicated by IRC through PD-L1 Subgroup: PD-L1 expression on tumor cells (TC) and on immune cells (IC) at baseline and in the following categories: <1%, >=1%, <5%, >=5%, <25%, >=25%, <50%, >=50% was reported.

Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (CR) or (PR) to the date of first documentation of 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 % 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 as adjudicated by IRC through MSI Status subgroups as:- MSI High = if participant is MSI High for any (at least one) test;- MSS or MSI Low = if participant is not MSI High for any test;- Unknown (missing) = no MSI tests available at baseline was reported. MSI high: if 2 or more unstable markers were detected in sample; MSI low: if 1 marker was unstable and remaining markers were stable and MSS if all markers were stable.

Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression

Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status

DRR was defined as the percentage of participants with confirmed OR (CR or PR) with duration of at least 6 months. 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 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DRR was determined according to RECIST v1.1 and adjudicated by IRC through MSI Status subgroups as:- MSI High = if participant is MSI High for any (at least one) test;- MSS or MSI Low = if participant is not MSI High for any test;- Unknown (missing) = no MSI tests available at baseline was reported. MSI high: if 2 or more unstable markers were detected in sample; MSI low: if 1 marker was unstable and remaining markers were stable and MSS if all markers were stable.

Full Information

NCT ID

NCT03833661

First Posted

February 6, 2019

Last Updated

October 24, 2023

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany

1. Study Identification

Unique Protocol Identification Number

NCT03833661

Brief Title

M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

Official Title

A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

March 26, 2019 (Actual)

Primary Completion Date

November 9, 2020 (Actual)

Study Completion Date

September 30, 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

The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.

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

M7824, Bintrafusp alfa (proposed INN), Transforming growth factor-beta, First-line Platinum-Based Chemotherapy, Programmed death-ligand 1, Metastatic Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

M7824

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

M7824

Other Intervention Name(s)

Bintrafusp alfa

Intervention Description

Participants received an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

Time from first treatment up to 555 days

Secondary Outcome Measure Information:

Title

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

Time from first documentation of objective response to data cutoff (assessed up to 736 days)

Title

Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

Description

Time Frame

Time from first treatment to data cutoff (assessed up to 736 days)

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs)

Description

Time Frame

Time from first treatment to data cutoff (assessed up to 736 days)

Title

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 first administration of study drug until the first documentation of PD or death, assessed up to data-cutoff (736 days)

Title

Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator

Description

Time Frame

Time from first treatment to data cutoff (assessed up to 736 days)

Title

Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator

Description

Time Frame

Time from first documentation of objective response to data cutoff (assessed up to 736 days)

Title

Durable Response Rate (DRR) Acoording to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator

Description

Time Frame

Time from first treatment to data cutoff (assessed up to 736 days)

Title

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator

Description

Time Frame

Time from first administration of study drug until the first documentation of PD or death, assessed up to data-cutoff (736 days)

Title

Overall Survival (OS)

Description

OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method.

Time Frame

Time from first administration of study drug to data cutoff (assessed up to 736 days)

Title

Serum Pre-Dose Concentrations (Ctrough) of M7824

Description

Ctrough was defined as the concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration for multiple dosing).

Time Frame

At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421 and Day 505

Title

Serum Concentration at End of Infusion (CEOI) of M7824

Description

Serum Concentration at End of Infusion (CEOI) of M7824 is reported.

Time Frame

At Day 1 and Day 29

Title

Number of Participants With Positive Antidrug Antibodies (ADA)

Description

Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.

Time Frame

Time from first treatment to data cutoff (assessed up to 736 days)

Title

Description

Time Frame

Time from first treatment to data cutoff (assessed up to 736 days)

Title

Description

Time Frame

Time from first treatment to data cutoff (assessed up to 736 days)

Title

Description

DOR was defined for participants with confirmed response, as the time from first documentation of objective response (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 as adjudicated by IRC through PD-L1 Subgroup: PD-L1 expression on tumor cells (TC) and on immune cells (IC) at baseline and in the following categories: <1%, >=1%, <5%, >=5%, <25%, >=25%, <50%, >=50% was reported.

Time Frame

Time from first documentation of objective response to data cutoff (assessed up to 736 days)

Title

Description

Time Frame

Time from first documentation of objective response to data cutoff (assessed up to 736 days)

Title

Description

Time Frame

Time from first treatment to data cutoff (assessed up to 736 days)

Title

Description

Time Frame

Time from first treatment to data cutoff (assessed up to 736 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. Availability of tumor (primary or metastatic) archival material or fresh biopsies is mandatory Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy administered for locally advanced or metastatic disease. Only one prior treatment line is allowed Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1 Life expectancy >= 12 weeks as judged by the Investigator Adequate hematological function defined by white blood cell (WBC) count >= 3 * 10^9/Litre with absolute neutrophil count (ANC) >= 1.5 * 109/Litre, lymphocyte count >= 0.5 * 10^9/Litre, platelet count >=75 * 10^9/Litre, and hemoglobin (Hgb) >= 9 grams/decilitre Adequate hepatic function defined by a total bilirubin level =< 1.5 * upper limit of normal (ULN), an aspartate aminotransferase (AST) level =< 2.5 * ULN, and an alanine aminotransferase (ALT) level =<2.5 * ULN. For participants with liver involvement in their tumor, AST =< 5.0 * ULN and ALT =< 5.0 * ULN is acceptable Adequate coagulation function defined as prothrombin time (PT) or international normalized ratio (INR) =< 1.5 * ULN unless the participant is receiving anticoagulant therapy Albumin >= 3.0 grams/decilitre Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals Adequate renal function defined by either creatinine =< 1.5 * ULN or an estimated creatinine clearance (CCr) > 40 milliliter (mL) per minute (min) according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection Other protocol defined inclusion criteria could apply Exclusion Criteria: Ampullary cancer was excluded Significant acute or chronic infections Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent Interstitial lung disease or its history Participants who were not eligible for or have not been treated with 1L systemic chemotherapy Anticancer treatment within 21 days before the start of study intervention Concurrent treatment with nonpermitted drugs Prior participation in a M7824 clinical trial Prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-PD 1, anti PD L1, anti- cytotoxic T-cell lymphocyte-4 (CTLA-4) antibodies. Pregnancy or breast feeding Systemic anticancer treatment after failing 1L platinum-based chemotherapy 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

Mayo Clinic Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

UCSF Mount Zion Medical Ctr

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

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

H. Lee Moffitt Cancer Center and Research Institute, Inc

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612-9497

Country

United States

Facility Name

Sidney Kimmel Comprehensive Cancer Center at John Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Mayo Clinic - Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

MD Anderson Cancer Center - Unit

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Peking University Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

Affiliated Tumor Hospital of Harbin Medical University

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

Groupe Hospitalier Sud - Hôpital Haut Lévêque - Service Hepato Gastroentérologie Oncologie Digest

City

Pessac Cedex

ZIP/Postal Code

33604

Country

France

Facility Name

ICO - Site René Gauducheau

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Institut Gustave Roussy

City

Villejuif cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Istituto Clinico Humanitas

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Unita' Operativa di Pediatria

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Fondazione IRCCS Istituto Nazionale dei Tumori Milano

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology

City

Chuo-ku

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

National Cancer Center Hospital East

City

Kashiwa-shi

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Kyorin University Hospital - Dept of Oncology

City

Mitaka-shi

ZIP/Postal Code

181-8611

Country

Japan

Facility Name

Kindai University Hospital - Dept of Gastroenterology

City

Osakasayama-shi

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Kanagawa Cancer Center

City

Yokohama-shi

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Hospital de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08027

Country

Spain

Facility Name

Hospital Universitari Vall d'Hebron - Dept of Oncology

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Facility Name

Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Chang Gung Memorial Hospital, Linkou

City

Linkou

ZIP/Postal Code

333

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

Facility Name

St James's University Hospital - Dept of Oncology

City

Leeds

ZIP/Postal Code

LS9 7TF

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_0047

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

M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

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