Skip to main content

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

Trial Status: Closed to Accrual

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

  • Male or female subjects
  • 18 years and older (Japan-20 years and older)
  • Confirmed 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.

Exclusion Criteria

  • Prior exposure to immune-mediated therapy
  • Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
  • GI Bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
  • Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose.
  • Main portal vein thrombosis (Vp4) as documented on imaging
  • 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

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL

Connecticut

New Haven
Yale University
Status: ACTIVE

Florida

Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL
Tampa
Moffitt Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Rachel Lynn Alvey
Phone: 317-278-6455

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Thomas Jefferson University Hospital
Status: CLOSED_TO_ACCRUAL

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: CLOSED_TO_ACCRUAL

Singapore

Singapore
Johns Hopkins Singapore
Status: CLOSED_TO_ACCRUAL
Contact: Akhil Chopra
Phone: 65-68802171

Trial Phase Phase II

Trial Type Treatment

Lead Organization
MedImmune Inc

  • Primary ID D4190C00022
  • Secondary IDs NCI-2016-00207
  • Clinicaltrials.gov ID NCT02519348