Skip to main content

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Trial Status: Active

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy.

Inclusion Criteria

  • HCC based on histopathological confirmation
  • No prior systemic therapy for HCC
  • Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
  • Child-Pugh Score class A
  • ECOG performance status of 0 or 1 at enrollment

Exclusion Criteria

  • Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
  • Clinically meaningful ascites
  • Main portal vein tumor thrombosis
  • Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
  • HBV and HVC co-infection, or HBV and Hep D co-infection

Arizona

Phoenix
Mayo Clinic Hospital in Arizona
Status: CLOSED_TO_ACCRUAL
Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: UCSF Clinical Trials
Phone: 877-827-3222

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

Florida

Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL

Kansas

Fairway
University of Kansas Clinical Research Center
Status: ACTIVE
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: COMPLETED
Brigham and Women's Hospital
Status: COMPLETED
Dana-Farber Cancer Institute
Status: COMPLETED

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Ghassan K. Abou-Alfa
Phone: 646-888-4184

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Marcella West Aguilar
Phone: 214-648-1479

The study population includes patients 18 years of age or older with advanced HCC, Barcelona

Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh

A classification liver disease. Patients must not have received any prior systemic therapy

for unresectable HCC.

Patients in all treatment arms may continue receiving their originally assigned treatment, at

the Investigator's discretion, until progression

Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to

receive benefit from their assigned treatment and meet the criteria for treatment in the

setting of PD may continue to receive their assigned treatment.

If a patient discontinues study drug(s) due to disease progression, the patient will enter

survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic

deterioration or who have commenced subsequent anticancer therapy, will have tumor

assessments until confirmed PD and will be followed for survival.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D419CC00002
  • Secondary IDs NCI-2018-01057
  • Clinicaltrials.gov ID NCT03298451