Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in combination with TACE in Patients with Locoregional HCC - EMERALD-3
Study identifier:D910VC00001
ClinicalTrials.gov identifier:NCT05301842
EudraCT identifier:2021-003822-54
CTIS identifier:N/A
Recruiting
Official Title
A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination with Tremelimumab ± Lenvatinib Given Concurrently with TACE Compared to TACE Alone in Patients with Locoregional Hepatocellular Carcinoma (EMERALD-3)
Medical condition
Hepatocellular Carcinoma
Phase
Phase 3
Healthy volunteers
No
Study drug
Tremelimumab, Durvalumab, Lenvatinib
Sex
All
Estimated Enrollment
725
Study type
Interventional
Age
18 Years - 120 Years
Date
Study Start Date: 28 Mar 2022
Estimated Primary Completion Date: 31 Dec 2025
Estimated Study Completion Date: 26 Feb 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE) | Drug: Tremelimumab Tremelimumab IV (intravenous) Other Name: MEDI1123 Drug: Durvalumab Durvalumab IV (intravenous) Other Name: MEDI4736 Procedure/Surgery: Transarterial Chemoembolization (TACE) TACE (chemo and embolic agent injection into the hepatic artery) Other Name: DEB-TACE and cTACE Drug: Lenvatinib Lenvatinib (oral) Other Name: Lenvima |
| Experimental: Arm B Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE) | Drug: Tremelimumab Tremelimumab IV (intravenous) Other Name: MEDI1123 Drug: Durvalumab Durvalumab IV (intravenous) Other Name: MEDI4736 Procedure/Surgery: Transarterial Chemoembolization (TACE) TACE (chemo and embolic agent injection into the hepatic artery) Other Name: DEB-TACE and cTACE |
| Active Comparator: Arm C Transarterial Chemoembolization (TACE) | Procedure/Surgery: Transarterial Chemoembolization (TACE) TACE (chemo and embolic agent injection into the hepatic artery) Other Name: DEB-TACE and cTACE |
