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

A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination with Tremelimumab ± Lenvatinib Given Concurrently with Transarterial Chemoembolization (TACE) Compared to TACE Alone in Patients with Locoregional Hepatocellular Carcinoma (EMERALD-3) - EMERALD-3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003822-54-PT

Enrollment

525

Registered

2022-12-06

Start date

2023-07-07

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Locoregional Hepatocellular Carcinoma (HCC) MedDRA version: 21.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Durvalumab Product Code: MEDI4736 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Durvalumab CAS Number: 1428935-60-7 Current Sponsor code: MEDI4736 Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - No evidence of extrahepatic disease - Disease not amenable to curative surgery or transplantation or curative ablation - Disease must be amenable to TACE - Child-Pugh score class A and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria - Adequate organ and marrow function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 315 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 210

Exclusion criteria

Exclusion criteria: - History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia - History of encephalopathy within past 12 months - Uncontrolled arterial hypertension - Co-infection with HBV and HDV - Major portal vein thrombosis visible on baseline imaging

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate superiority of durvalumab + tremelimumab + lenvatinib + TACE relative to TACE alone by assessment of PFS in participants with locoregional HCC;Secondary Objective: To demonstrate superiority of durvalumab + tremelimumab + TACE relative to TACE alone by assessment of PFS in participants with locoregional HCC To demonstrate superiority of durvalumab + tremelimumab + lenvatinib + TACE relative to TACE alone by assessment of OS in participants with locoregional HCC To demonstrate superiority of durvalumab + tremelimumab + TACE relative to TACE alone by assessment of OS in participants with locoregional HCC;Primary end point(s): Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR;Timepoint(s) of evaluation of this end point: Assessments for PFS will be collected regularly at predefined time points until disease progression	—

Measure

Time frame

Main Objective: To demonstrate superiority of durvalumab + tremelimumab + lenvatinib + TACE relative to TACE alone by assessment of PFS in participants with locoregional HCC;Secondary Objective: To demonstrate superiority of durvalumab + tremelimumab + TACE relative to TACE alone by assessment of PFS in participants with locoregional HCC To demonstrate superiority of durvalumab + tremelimumab + lenvatinib + TACE relative to TACE alone by assessment of OS in participants with locoregional HCC To demonstrate superiority of durvalumab + tremelimumab + TACE relative to TACE alone by assessment of OS in participants with locoregional HCC;Primary end point(s): Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR;Timepoint(s) of evaluation of this end point: Assessments for PFS will be collected regularly at predefined time points until disease progression

—

Secondary

Measure	Time frame
Secondary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: Assessments will be made regularly until disease progression or until the end of the study	—

Countries

Brazil, Canada, China, Egypt, France, Germany, India, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Philippines, Portugal, Russian Federation, Spain, Taiwan, Thailand, United States, Viet Nam

Contacts

Public ContactClinical Study Information Center

AstraZeneca

information.center@astrazeneca.com1877240-9479

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026