Clinical trial

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Name

D419CC00002

Description

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

Trial arms

Trial start

2017-10-11

Estimated PCD

2021-08-27

Trial end

2024-08-27

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Durvalumab

Durvalumab IV (intravenous infusion).

Arms:

Arm 1

Other names:

MEDI4736

Tremelimumab (Regimen 1)

Tremelimumab IV (intravenous infusion).

Arms:

Arm 2

Tremelimumab (Regimen 2)

Tremelimumab IV (intravenous infusion).

Arms:

Arm 3

Sorafenib

Sorafenib, as per standard of care

Arms:

Arm 4

Durvalumab (Regimen 1)

Durvalumab IV (intravenous infusion).

Arms:

Arm 2

Durvalumab (Regimen 2)

Durvalumab IV (intravenous infusion).

Arms:

Arm 3

Size

1324

Primary endpoint

Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg

From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1324, 'type': 'ACTUAL'}}

Updated at

2024-04-25

1 organization

3 products

1 drug

2 abstracts

1 indication

Organization

AstraZeneca

Drug

AN0025

Indication

Hepatocellular Carcinoma

Product

Tremelimumab

Product

Sorafenib

Product

Durvalumab

Abstract

Outcomes by occurrence of immune-mediated adverse events (imAEs) with tremelimumab (T) plus durvalumab (D) in the phase 3 HIMALAYA study in unresectable hepatocellular carcinoma (uHCC).

Org: Humanity and Health Clinical Trial Center, Liver Unit and HPB Oncology Area, Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Hokkaido, Japan, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Barcelona Clinic Liver Cancer,

Abstract

Temporal patterns of immune-mediated adverse events (imAEs) with tremelimumab (T) plus durvalumab (D) in the phase 3 HIMALAYA study in unresectable hepatocellular carcinoma (uHCC).

Org: Humanity and Health Clinical Trial Center, Humanity and Health Medical Group, Rogel Cancer Center, Department of Medicine, Icahn School of Medicine at Mount Sinai, Bashkir State Medical University,