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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

Connecticut

New Haven
Yale University
Status: Active
Name Not Available

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Temporarily closed to accrual
Contact: Rachel Lynn Alvey
Phone: 317-278-6455
Email: rlalvey@iu.edu

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Name Not Available

Singapore

Singapore
Johns Hopkins Singapore
Status: Active
Contact: Akhil Chopra
Phone: 65-68802171
Email: akhilchopra@imc.jhmi.edu

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
MedImmune Inc

Trial IDs

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