Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono Research & Development Institute, Inc.
With
Merck KGaA, Darmstadt, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Clareo Health | Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
