A clinical trial in patients with advanced liver cancer. The trial will investigate the safety, tolerability and clinical activitiy of durvalumab or tremelimumab as monoterapy, durvalumab combined with tremelimumab, or durvalumab combined with bevacizumab

Phase 1

• Conditions: Hepatocellular Carcinoma; MedDRA version: 21.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001663-39-IT
• Lead Sponsor: MEDIMMUNE, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-22
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

1. Male or female subjects
2. 18 years and older
3. Confirmed HCC based on histopathological findings from tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.
4. Immunotherapy-naive and have either progressed on, are intolerant to, or refused treatment with sorafenib or another approved VEGFR TKI. Part 4 only: Must not have received prior systemic therapy for HCC.
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 292
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 164

Exclusion Criteria

1. Prior exposure to immune-mediated therapy
2. Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
3. GI Bleeding (eg, esophageal varices or ulcer bleeding) within 12 months.
4. Ascites requiring nonpharmacologic intervention to maintain symptom control, within 6 months prior to the first scheduled dose.
5. Main portal vein thrombosis (Vp4) as documented on imaging
6. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
7. Active or prior documented autoimmune or inflammatory disease with some exceptions
8. Current or prior use of immunosuppressive medication within 14 days of first dose of IP, with some exceptions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified