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NCT Number: NCT05301842

Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Brussels, Belgium

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No evidence of extrahepatic disease
  • Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
  • Child Pugh score class A
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
  • Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
  • Adequate organ and marrow function

Exclusion criteria

  • History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia
  • History of hepatic encephalopathy
  • Major portal vein thrombosis visible on baseline imaging
  • Uncontrolled arterial hypertension
  • Co-infection with HBV and HDV

Treatment and study plan

Tremelimumab

Drug

Tremelimumab IV (intravenous)

Other names: MEDI1123

Durvalumab

Drug

Durvalumab IV (intravenous)

Other names: MEDI4736

Transarterial chemoembolization (TACE)

Procedure

TACE (chemo and embolic agent injection into the hepatic artery)

Other names: DEB-TACE and cTACE

Lenvatinib

Drug

Lenvatinib (oral)

Other names: Lenvima

Primary outcomes

  1. Progression Free Survival (PFS) for Arm A vs Arm C

    Time frame: Approximately 5 years

    PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause

Secondary outcomes

  1. Overall Survival (OS) for Arm A vs Arm C

    Time frame: Approximately 5 years

    OS is defined as the time from the date of randomization until death due to any cause

  2. Progression Free Survival (PFS) for Arm B vs Arm C

    Time frame: Approximately 5 years

    PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause

  3. Overall Survival (OS) for Arm B vs Arm C

    Time frame: Approximately 5 years

    OS is defined as the time from the date of randomization until death due to any cause

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: EMERALD-3

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 31, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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