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A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
Sponsor: MedImmune LLC
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
433
Start Date
2015-10-19
Completion Date
2026-04-01
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Tremelimumab
Tremelimumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.
Durvalumab
Durvalumab will be administered by IV infusion according to doses and frequency mentioned in arms' description.
Bevacizumab
Bevacizumab 15 mg/kg will be administered by IV infusion every 3 weeks until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurred first.
Locations (44)
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Phoenix, Arizona, United States
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San Francisco, California, United States
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New Haven, Connecticut, United States
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Jacksonville, Florida, United States
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Tampa, Florida, United States
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Indianapolis, Indiana, United States
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Boston, Massachusetts, United States
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New York, New York, United States
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Stony Brook, New York, United States
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Durham, North Carolina, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Seattle, Washington, United States
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Hangzhou, China
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Nanjing, China
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Shanghai, China
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Benevento, Italy
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Milan, Italy
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Roma, Italy
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Chūōku, Japan
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Kashiwa, Japan
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Osakasayama-shi, Japan
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Bukit Merah, Singapore
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Singapore, Singapore
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Singapore, Singapore
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Busan, South Korea
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Junggu, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Barcelona, Spain
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Córdoba, Spain
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Pamplona, Spain
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Kaohsiung City, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan