NCT02519348Active, not recruitingPhase 2
A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
A Study of Safety, Tolerability, and Clinical Activity of Durvalumab and Tremelimumab Administered as Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Subjects With Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 433 (actual)
- First submitted
- 30 Jul 2015
- Start date
- 19 Oct 2015
- Primary completion date
- 6 Nov 2020
- Lead sponsor
- MedImmune LLC
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT02519348
- EU CT number
- 2024-517085-41-00
- EudraCT number
- 2015-001663-39
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 433
- From 19 Oct 2015 to the primary completion date, 6 Nov 2020
- 36 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to immune-mediated therapy
- Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
- Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose.
- 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
Other illness
- Gastrointestinal bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
- Main portal vein thrombosis (Vp4) as documented on imaging
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Osakasayama-shi | Japan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Junggu | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Bukit Merah | Singapore | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.