Clinical trial · Interventional
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival.
Summary
Brief summary (as posted)
Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| M7824 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Safety Run-In Part: M7824 + Gemcitabine + Cisplatin
- interventionNames
- Drug: M7824
- Drug: Gemcitabine
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Double-blinded Part: M7824 + Gemcitabine + Cisplatin
- interventionNames
- Drug: M7824
- Drug: Gemcitabine
- Drug: Cisplatin
- type
- PLACEBO_COMPARATOR
- label
- Double-blinded Part: Placebo + Gemcitabine + Cisplatin
- interventionNames
- Drug: Placebo
- Drug: Gemcitabine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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
References
Publications (2)
- RESULTYoo 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. PMID 32461347
- DERIVEDOh DY, Ikeda M, Lee CK, Rojas C, Hsu CH, Kim JW, Shen L, Furuse J, Park JO, Borad M, de Braud F, Bridgewater J, Lee SS, Moehler M, Audhuy F, Osada M, Sato M, Yoo C. Bintrafusp alfa and chemotherapy as first-line treatment in biliary tract cancer: A randomized phase 2/3 trial. Hepatology. 2025 Mar 1;81(3):823-836. doi: 10.1097/HEP.0000000000000965. Epub 2024 Jun 14. PMID 38875119