Study identifier:D419CC00002
ClinicalTrials.gov identifier:NCT03298451
EudraCT identifier:2016-005126-11
CTIS identifier:N/A
A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients with Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma
Phase 3
No
Durvalumab, Tremelimumab (Regimen 1), Tremelimumab (Regimen 2), Sorafenib, Durvalumab (Regimen 1), Durvalumab (Regimen 2)
All
1324
Interventional
18 Years - 100 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 Durvalumab | Drug: Durvalumab Durvalumab IV (intravenous infusion). Other Name: MEDI4736 |
Experimental: Arm 2 Durvalumab in combination with tremelimumab (Regimen 1) | Drug: Tremelimumab (Regimen 1) Tremelimumab IV (intravenous infusion). Drug: Durvalumab (Regimen 1) Durvalumab IV (intravenous infusion). |
Experimental: Arm 3 Durvalumab in combination with tremelimumab (Regimen 2) | Drug: Tremelimumab (Regimen 2) Tremelimumab IV (intravenous infusion). Drug: Durvalumab (Regimen 2) Durvalumab IV (intravenous infusion). |
Active Comparator: Arm 4 Sorafenib | Drug: Sorafenib Sorafenib, as per standard of care |