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



Status:Recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:3/17/2019
Start Date:October 19, 2015
End Date:October 30, 2020
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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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

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


Inclusion Criteria:

1. Male or female subjects

2. 18 years and older (Japan-20 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-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:

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 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
We found this trial at
15
sites
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Durham, NC
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Beijing,
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Boston, MA
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Dallas, TX
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Indianapolis, IN
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Jacksonville, FL
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Nashville, TN
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New Haven, CT
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New York, NY
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Philadelphia, PA
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Portland, OR
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San Francisco, CA
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Scottsdale, AZ
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Seattle, WA
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Tampa, FL
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