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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
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

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Research Site
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HangzhouChinaUnknown status
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NanjingChinaUnknown status
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ShanghaiChinaUnknown status
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BarcelonaSpainUnknown status
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CórdobaSpainUnknown status
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PamplonaSpainUnknown status
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Hong KongHong Kong SAR ChinaUnknown status
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ShatinHong Kong SAR ChinaUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
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ChūōkuJapanUnknown status
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KashiwaJapanUnknown status
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Osakasayama-shiJapanUnknown status
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BusanSouth KoreaUnknown status
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JungguSouth KoreaUnknown status
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Seongnam-siSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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Bukit MerahSingaporeUnknown status
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SingaporeSingaporeUnknown status
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Kaohsiung CityTaiwanUnknown status
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TaipeiTaiwanUnknown status
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Taoyuan CityTaiwanUnknown status
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BostonUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DurhamUnited StatesUnknown status
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IndianapolisUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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NashvilleUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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PortlandUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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SeattleUnited StatesUnknown status
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Stony BrookUnited StatesUnknown status
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TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.