A Study of Safety, Tolerability, and Clinical Activity of MEDI4736 and Tremelimumab Administered as Monotherapy and in Combination to Subjects With Unresectable Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: JPRN-jRCT2080223264
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 40

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>-

Secondary Outcome Measures

Name	Time	Method
efficacy<br>-