Hepatocellular Carcinoma
Conditions
Interventions
investigational material(s)
Generic name etc : MEDI4736 + tremelimumab, MEDI4736, tremelimumab
INN of investigational material : durvalumab + tremelimumab, durvalumab, tremelimumab
Therapeutic categor
Sponsors
AstraZeneca
MedImmune LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Confirmed HCC based on histopathological findings from tumor tissues. Unresectable HCC with diagnosis confirmed pathologically or with noninvasive methods - Immunotherapy-naive and have either progressed on, are intolerant to, or refused treatment with sorafenib. Subjects who receive treatment with systemic therapies other than sorafenib are not eligible 18 Years and older (20 years and older in Japan)
Exclusion criteria
Exclusion criteria: - Prior exposure to immune-mediated therapy - Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy - GI Bleeding (eg, esophageal varices or ulcer bleeding) within 12 months - Ascites requiring non-pharmacologic intervention or escalation in pharmacologic intervention to maintain symptom control, within 6 months prior to the first scheduled dose - Main portal vein thrombosis(Vp4) as documented on imaging - Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment - Active or prior documented autoimmune or inflammatory disease with some exceptions - Current or prior use of immunosuppressive medication within 14 days with some exceptions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Countries
Asia except Japan, Europe, Japan, North America
Outcome results
None listed