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Pembrolizumab and Bavituximab in Advanced Hepatocellular Carcinoma
NCT03519997Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2018
- Primary completion
- Apr 2023
- Countries
- 1
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- bavituximab
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, open-label, single-arm trial of bavituximab in hepatocellular carcinoma (HCC). Primary endpoint: Overall Response Rate at 36 months. Started Apr 2018; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Pembro + Bavi
Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly
03
Who it enrols
Adults with locally advanced or metastatic hepatocellular carcinoma, Child-Pugh A, ECOG 0-1, no prior systemic therapy for HCC, adequate organ function, and no active autoimmune disease or severe heart disease.
04
Endpoints
Primary
Overall Response Rate
Secondary
Overall Survival
Number of Adverse Events According to the CTCAE
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