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

Study identifier:D419CC00002

ClinicalTrials.gov identifier:NCT03298451

EudraCT identifier:2016-005126-11

CTIS identifier:N/A

Recruitment Complete

Official Title

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

Medical condition

Hepatocellular Carcinoma

Phase

Phase 3

Healthy volunteers

No

Study drug

Durvalumab, Tremelimumab (Regimen 1), Tremelimumab (Regimen 2), Sorafenib, Durvalumab (Regimen 1), Durvalumab (Regimen 2)

Sex

All

Actual Enrollment

1324

Study type

Interventional

Age

18 Years - 100 Years

Date

Study Start Date: 11 Oct 2017
Primary Completion Date: 27 Aug 2021
Estimated Study Completion Date: 27 Aug 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria