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

NCT02519348

Active Not RecruitingPhase 2

Sponsor: MedImmune LLC

Conditions: Hepatocellular Carcinoma

Interventions: Tremelimumab, Durvalumab, Bevacizumab

Countries: United States, China, Hong Kong, Italy, Japan, Singapore, South Korea, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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:

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
Locations (44)
  • Phoenix, Arizona, United States
  • San Francisco, California, United States
  • New Haven, Connecticut, United States
  • Jacksonville, Florida, United States
  • Tampa, Florida, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • New York, New York, United States
  • Stony Brook, New York, United States
  • Durham, North Carolina, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Seattle, Washington, United States
  • Hangzhou, China
  • Nanjing, China
  • Shanghai, China
  • Hong Kong, Hong Kong
  • Shatin, Hong Kong
  • Benevento, Italy
  • Milan, Italy
  • Roma, Italy
  • Chūōku, Japan
  • Kashiwa, Japan
  • Osakasayama-shi, Japan
  • Bukit Merah, Singapore
  • Singapore, Singapore
  • Singapore, Singapore
  • + 14 more on CT.gov