A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

Running, not enrolling · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.

Key facts

Study ID

NCT02519348

Run by

MedImmune LLC

People needed

433

Starts

2015-10-19

Expected to finish

2026-12-18

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants
• 18 years and older (Japan-20 years and older)
• Confirmed hepatocellular carcinoma (HCC) based on histopathological findings from tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.
• Immunotherapy-naïve
• Have either progressed on, are intolerant to, or refused treatment with sorafenib or another approved TKI. For arm 5 only: Have not received any prior systemic therapy for HCC.

You may not qualify if…

• Prior exposure to immune-mediated therapy
• Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
• Gastrointestinal bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
• Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic 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

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — San Francisco, California, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — New York, New York, United States
• Research Site — Stony Brook, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Portland, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Dallas, Texas, United States
• Research Site — Seattle, Washington, United States
• Research Site — Hangzhou, China
• Research Site — Nanjing, China
• Research Site — Shanghai, China
• Research Site — Hong Kong, Hong Kong
• Research Site — Shatin, Hong Kong
• Research Site — Benevento, Italy
• Research Site — Milan, Italy
• Research Site — Roma, Italy
• Research Site — Chūōku, Japan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.