A clinical trial in patients with liver cancer that cannot be removed by surgery, investigating the safety, tolerability, and clinical activity of investigational drugs MEDI4736 and tremelimumab. The study will look at the effect of these two drugs either as a single agents (monotherapy) or as combination therapy (when given together to patients).
- Conditions
- Hepatocellular CarcinomaMedDRA version: 18.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001663-39-ES
- Lead Sponsor
- MedImmune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1. Male or female subjects
2. 18 years and older
3. Confirmed diagnosis of unresectable hepatocellular carcinoma with or without concomitant viral hepatits B or hepatitis C infection.
4. Subjects must have either: progressed on, are intolerant to, or refused treatment with sorafenib.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Prior exposure to immune-mediated therapy
2. Hepatic encephalopathy characterized by asterixis
3. Active or prior documented gastrointestinal variceal bleed
4. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
6. Active or prior documented autoimmune or inflammatory disease with some exceptions
7. Current or prior use of immunosuppressive medication within 14 days with some exceptions
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method