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Clinical Trials List

Protocol NumberMS200647_0055
NCT Number(ClinicalTrials.gov Identfier)NCT04066491

2019-11-01 - 2023-01-31

Phase II/III

Recruiting7

ICD-10D01.5

Carcinoma in situ of liver, gallbladder and bile ducts

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 Cance

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Merck Healthcare KGaA

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Ming-Huang Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Shi Chen Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tai-Jan Chiu Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TENG-YU LEE Digestive System Department
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Biliary Tract Cancer

Objectives

Open-label Safety Run-in To assess the following items with M7824 2400 mg Q3W in combination with gemcitabine and cisplatin in locally advanced or metastatic BTC Primary To assess if M7824 2400 mg Q3W is safe and tolerable and to confirm this dose as the recommended Phase II dose for the randomized, double-blind part of the study Secondary To assess the safety profile of M7824 in combination with gemcitabine and cisplatin

Test Drug

Bintrafusp alfa (M7824)

Active Ingredient

M7824 (MSB0011359C)

Dosage Form

Concentrate for solution for infusion

Dosage

10 mg/mL; 600 mg/vial

Endpoints

Primary Outcome Measures :
Safety Run-in Part: Number of Participants with Dose-Limiting Toxicities (DLTs) During the DLT Evaluation Period [ Time Frame: Day 1 up to Day 21 of Cycle 1 (each Cycle is of 21 days) ]
Double-blinded Part: Overall Survival (OS) [ Time Frame: First dose of study intervention up to 4 years ]

Secondary Outcome Measures :
Safety Run-in Part: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events [ Time Frame: First dose of study intervention up to 4 years ]
Safety Run-in Part: Number of Participants with Abnormalities (Grade >= 3) in Laboratory Tests [ Time Frame: First dose of study intervention up to 4 years ]
Double-blinded: Confirmed Objective Response (COR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Assessed by Investigator [ Time Frame: First dose of study intervention up to 4 years ]
Double-blinded Part: Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator or Death [ Time Frame: Time from CR or PR up to 4 years ]
Double-blinded Part: Durable Response of at Least 6 Months According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator [ Time Frame: First dose of study intervention up to 4 years ]
Double-blinded Part: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment Related Adverse Events and Adverse Events of Special Interest (AESI) [ Time Frame: First dose of study intervention up to 4 years ]
Double-blinded Part: Serum Concentration Observed Immediately at the End of Infusion (Ceoi) of Bintrafusp alfa [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1 Day 1, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years ]
Double-blinded Part: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Bintrafusp alfa [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1 Day 1, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years ]
Safety Run-in Part: Area Under Serum Concentration-Time Curve (AUC0-t) From Time Zero to The Last Sampling Time of Bintrafusp alfa [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1 Day 1 and Day 2, Week 2 Day 8, Week 3 Day 15, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years ]
Safety Run-in Part: Area Under Serum Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of Bintrafusp alfa [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1 Day 1 and Day 2, Week 2 Day 8, Week 3 Day 15, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years ]
Safety Run-in Part: Maximum Observed Serum Concentration (Cmax) of Bintrafusp alfa [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1 Day 1 and Day 2, Week 2 Day 8, Week 3 Day 15, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years ]
Safety Run-in Part: Time to Reach Maximum Observed Serum Concentration (Tmax) of Bintrafusp alfa [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1 Day 1 and Day 2, Week 2 Day 8, Week 3 Day 15, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years ]
Safety Run-in Part: Apparent Terminal Half-Life (t1/2) of Bintrafusp alfa [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1 Day 1 and Day 2, Week 2 Day 8, Week 3 Day 15, Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years ]
Double-blinded Part: Immunogenicity as measured by Anti-drug Antibodies Concentration [ Time Frame: Pre-dose, 30 minutes post-dose at Week 4 Day 22, Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, Week 25 Day 169 and every 12 week from Week 25 approximately up to 4 years ]
Double-blinded Part: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Assessed by Investigator [ Time Frame: First dose of study intervention up to 4 years ]

Inclution 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

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

The Estimated Number of Participants

  • Taiwan

    70 participants

  • Global

    524 participants

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