For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Male or female participants
  2. 18 years and older (Japan-20 years and older)
  3. Confirmed hepatocellular carcinoma (HCC) based on histopathological findings from tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.
  4. Immunotherapy-naïve
  5. 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.

EXCLUSION CRITERIA

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. Gastrointestinal bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
  4. Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic 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 with some exceptions

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Hepatocellular Carcinoma

Age (in years)

18 - 99

Phase

Phase 2

Participants needed

433

Est. Completion Date

Dec 29, 2023

Treatment type

Interventional


Sponsor

MedImmune LLC

ClinicalTrials.gov identifier

NCT02519348

Study number

D4190C00022

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