1L BTC Phase II/III Gemcitabine Plus Cisplatin With or Without Bintrafusp alfa (M7824)

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224877

Enrollment

524

Registered

2019-09-18

Start date

2019-10-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer

Interventions

investigational material(s) Generic name etc : M7824 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion 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 Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals

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 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)

Design outcomes

Primary

Measure	Time frame
safety efficacy exploratory -	—

Secondary

Measure	Time frame
pharmacokinetics pharmacogenomics -	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026