Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
Stopped early · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
In brief
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.
Key facts
- Study ID
- NCT04066491
- Run by
- EMD Serono Research & Development Institute, Inc.
- People needed
- 309
- Starts
- 2019-09-20
- Expected to finish
- 2022-11-10
- Last updated by the study team
- 2023-11-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
- Other protocol defined inclusion criteria could apply
You may not qualify 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)
- Other protocol defined exclusion criteria could apply
Where it is running
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
- Mayo Clinic Arizona — Phoenix, Arizona, United States
- Beverly Hills Cancer Center — Beverly Hills, California, United States
- Mayo Clinic in Florida - Department of Neurology — Jacksonville, Florida, United States
- Mount Sinai Medical Center — Miami Beach, Florida, United States
- University of Kansas Medical Center Research Institute, Inc. - University of Kansas Cancer Center/Bloch Pavilion — Westwood, Kansas, United States
- Sidney Kimmel Comprehensive Cancer Center at John Hopkins — Baltimore, Maryland, United States
- Mayo Clinic - Rochester — Rochester, Minnesota, United States
- Methodist Transplant Physicians — Dallas, Texas, United States
- MD Anderson Cancer Center - Unit 429 — Houston, Texas, United States
- Renovatio Clinical - CENTRAL SITE — The Woodlands, Texas, United States
- Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo — Ciudad Autonoma Buenos Aires, Argentina
- Instituto de Investigaciones Metabolicas (IDIM) — Ciudad Autonoma Buenos Aires, Argentina
- Instituto Medico Especializado Alexander Fleming — Ciudad Autonoma Buenos Aires, Argentina
- Centro Oncologico Riojano Integral (CORI) — La Rioja, Argentina
- CEDIT — Salta, Argentina
- Centro Medico San Roque S.R.L. — San Miguel de Tucumán, Argentina
- Fundacion ARS Medica — San Salvador de Jujuy, Argentina
- Blacktown Hospital - PARENT — Blacktown, Australia
- Monash Health — Clayton, Australia
- Epworth Freemasons — Melbourne, Australia
- Icon Cancer Care South Brisbane — South Brisbane, Australia
- Hospital de Câncer de Barretos - Fundação Pio XII — Barretos, Brazil
- INCA - Instituto Nacional de Câncer — Rio de Janeiro, Brazil
- Ironwood Cancer & Research Centers - Chandler II — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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