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

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05301842

Acronym

EMERALD-3

Enrollment

760

Registered

2022-03-31

Start date

2022-03-28

Completion date

2027-02-26

Last updated

2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Locoregional HCC, Durvalumab, Tremelimumab, Lenvatinib, TACE, Liver Cancer

Brief summary

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

Detailed description

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).

Interventions

DRUGTremelimumab

Tremelimumab IV (intravenous)

DRUGDurvalumab

Durvalumab IV (intravenous)

PROCEDURETransarterial Chemoembolization (TACE)

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

DRUGLenvatinib

Lenvatinib (oral)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Open-label

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Progression Free Survival (PFS) for Arm A vs Arm C	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

Measure	Time frame	Description
Overall Survival (OS) for Arm A vs Arm C	Approximately 5 years	OS is defined as the time from the date of randomization until death due to any cause
Progression Free Survival (PFS) for Arm B vs Arm C	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
Overall Survival (OS) for Arm B vs Arm C	Approximately 5 years	OS is defined as the time from the date of randomization until death due to any cause

Countries

Belgium, Brazil, Canada, China, Egypt, France, Germany, India, Italy, Japan, Malaysia, Mexico, Philippines, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Taiwan, Thailand, United States, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026