Study identifier:D910VC00001
ClinicalTrials.gov identifier:NCT05301842
EudraCT identifier:2021-003822-54
CTIS identifier:2023-508701-24-00
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)
Hepatocellular Carcinoma
Phase 3
No
Tremelimumab, Durvalumab, Lenvatinib
All
760
Interventional
18 Years - 120 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jan 2025 by AstraZeneca
AstraZeneca
-
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).
Location
Location
Taipei, Taiwan, Province of China, TAIWAN
Location
Busan, Republic of Korea, 49241
Location
Seoul, Republic of Korea, 03080
Location
Ottawa, ON, Canada, K1H 8L6
Location
Kingston, ON, Canada, K7L 5P9
Location
Commack, NY, United States, 11725
Location
Memphis, TN, United States, 38104
Location
Bangkok, Thailand, 10300
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 |
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