Study Name
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC)
ClinicalTrials.gov Identifier (if applicable)
NCT04066491
Clinical Trial Category (check all that apply)
  • First Line Therapy
Study Center
Institution Name
EMD Serono Research & Development Institute, Inc.
State
– Please Select –
Country
United States
List additional Institutions (include address, phone number, and website)
For the updated list of institutions, please refer to study locations listed in ClinicalTrials.gov.
Study Contacts
Principal Investigator
Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
P.I. Phone
(888) 275-7376
P.I. Email
service@emdgroup.com
List additional Principal Investigators (include phone number and email)
For the updated list of Principal Investigators, please refer to study locations listed in ClinicalTrials.gov.
Study Coordinator
Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Coordinator Phone
(888) 275-7376
Study Coordinator Email
service@emdgroup.com
OVERVIEW – in layman’s terms (150 words max)
This randomized, double-blind, placebo-controlled Phase 2/3 study will evaluate whether bintrafusp alfa in combination with current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.
Enrollment
512
Study Start Date
09/20/2019
Estimated Completion Date
07/24/2023
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • Study aims to assess an investigational drug compared with a matching placebo, when given with combination chemotherapy of gemcitabine plus cisplatin. This study will assess the intervention as a potential first-option treatment, looking primarily at safety (side effects), tolerability (how well the drug is tolerated), and efficacy (response).
Inclusion Criteria – Patients Must:
  • Locally advanced or metastatic BTC have not had treatment for the cancer with chemotherapy, immunotherapy, or radiotherapy, people whose BTC has recurred 6 months or more after completion of adjuvant treatment may also be eligible
  • Have histologically or cytologically confirmed locally advanced or metastatic BTC
  • Have available tumor tissue (primary or metastatic) (archival or fresh biopsies) before the first administration of study treatment
  • Have at least 1 measurable lesion according to RECIST 1.1
  • Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry and at Week 1, Day 1 prior to dosing
  • Have life expectancy of >= 12 weeks, as judged by the Investigator
  • Have 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 – Patients Must NOT:
  • Have previous and/or intercurrent cancers
  • Be a recipient of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression
  • Have symptomatic central nervous system (CNS) metastases
  • Have 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
  • Have active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Have a history of or concurrent interstitial lung disease
  • Have history of hypersensitivity reactions to bintrafusp alfa, anaphylaxis, or recent (within 5 months) uncontrolled asthma, cardiovascular/cerebrovascular disease
  • Have chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
  • Have prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints)
  • Other protocol defined exclusion criteria could apply