Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC (EMERALD-3)

July 10, 2026 updated by: AstraZeneca

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)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

760

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Research Site
      • Ghent, Belgium, 9000
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Brasília, Brazil, 71681-603
        • Research Site
      • Niterói, Brazil, 24020-096
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Rio de Janeiro, Brazil, 20231-050
        • Research Site
      • Santa Maria, Brazil, 97015-450
        • Research Site
      • Santo André, Brazil, 09060-650
        • Research Site
      • São Paulo, Brazil, 04014-002
        • Research Site
      • Vitória, Brazil, 29043-272
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Research Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Montreal, Quebec, Canada, H2X 3E4
        • Research Site
  • China
      • Beijing, China, 100142
        • Research Site
      • Beijing, China, 100021
        • Research Site
      • Beijing, China, 100069
        • Research Site
      • Changchun, China, 130021
        • Research Site
      • Changsha, China, 410013
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Fuzhou, China, 350011
        • Research Site
      • Fuzhou, China, 350001
        • Research Site
      • Guangzhou, China, 510060
        • Research Site
      • Guangzhou, China, 510515
        • Research Site
      • Haikou, China, 570311
        • Research Site
      • Hangzhou, China, 310022
        • Research Site
      • Harbin, China, 150081
        • Research Site
      • Hefei, China, 230001
        • Research Site
      • Lanzhou, China, 730030
        • Research Site
      • Lishui, China, 323000
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Nanjing, China, 210002
        • Research Site
      • Nantong, China, 226361
        • Research Site
      • Neijiang, China, 641000
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Suzhou, China, 215004
        • Research Site
      • Tianjin, China, 300170
        • Research Site
      • Wenzhou, China, 325000
        • Research Site
      • Wuhan, China, 430022
        • Research Site
      • Wuhan, China, 430010
        • Research Site
      • Xi'an, China, 710000
        • Research Site
      • Zhengzhou, China, 450008
        • Research Site
      • Zhuhai, China, 519000
        • Research Site
  • Egypt
      • Al Mansurah, Egypt, 7650001
        • Research Site
      • Cairo, Egypt, 11451
        • Research Site
      • Shebeen El Kom, Egypt, 32511
        • Research Site
  • France
      • Angers, France, 49933
        • Research Site
      • Clichy, France, 92110
        • Research Site
      • Créteil, France, 94010
        • Research Site
      • Montpellier, France, 34295
        • Research Site
      • Nantes, France, 44093
        • Research Site
      • Nice, France, 06200
        • Research Site
      • Paris, France, 75013
        • Research Site
      • Strasbourg, France, 67091
        • Research Site
      • Toulouse, France, 31059
        • Research Site
      • Vandœuvre-lès-Nancy, France, 54511
        • Research Site
  • Germany
      • Bonn, Germany, 53127
        • Research Site
      • Chemnitz, Germany, 09116
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Düsseldorf, Germany, 40225
        • Research Site
      • Frankfurt, Germany, 60596
        • Research Site
      • Göttingen, Germany, 37075
        • Research Site
      • Hamburg, Germany, 22291
        • Research Site
      • Hanover, Germany, 30625
        • Research Site
      • Heidelberg, Germany, 69120
        • Research Site
      • Kiel, Germany, 24105
        • Research Site
      • Leipzig, Germany, 04103
        • Research Site
      • Magdeburg, Germany, 39120
        • Research Site
      • Ulm, Germany, 89081
        • Research Site
  • India
      • Ahmedabad, India, 380060
        • Research Site
      • Ahmedabad, India, 380054
        • Research Site
      • Bangalore, India, 560027
        • Research Site
      • Delhi, India, 110029
        • Research Site
      • Hyderabad, India, 500032
        • Research Site
      • Jaipur, India, 302022
        • Research Site
      • Kolkata, India, 700099
        • Research Site
      • Mumbai, India, 400012
        • Research Site
      • New Delhi, India, 110 085
        • Research Site
      • New Delhi, India, 110005
        • Research Site
  • Italy
      • Arezzo, Italy, 52100
        • Research Site
      • Florence, Italy, 50134
        • Research Site
      • Milan, Italy, 20132
        • Research Site
      • Milan, Italy, 20133
        • Research Site
      • Roma, Italy, 00128
        • Research Site
      • Rozzano, Italy, 20089
        • Research Site
      • Tricase, Italy, 73039
        • Research Site
  • Japan
      • Chūōku, Japan, 104-0045
        • Research Site
      • Fukuoka, Japan, 810-8563
        • Research Site
      • Hiroshima, Japan, 734-8551
        • Research Site
      • Kashihara-shi, Japan, 634-8522
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Research Site
      • Kumamoto, Japan, 860-8556
        • Research Site
      • Mitaka-shi, Japan, 181-8611
        • Research Site
      • Morioka, Japan, 028-3695
        • Research Site
      • Musashino-shi, Japan, 180-8610
        • Research Site
      • Okayama, Japan, 700-8558
        • Research Site
      • Osaka, Japan, 545-8586
        • Research Site
      • Osaka, Japan, 543-8555
        • Research Site
      • Osakasayama-shi, Japan, 589-8511
        • Research Site
      • Sapporo, Japan, 006-8555
        • Research Site
      • Sendai, Japan, 981-0914
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Research Site
      • Tokushima, Japan, 770-8503
        • Research Site
      • Tsu, Japan, 514-8507
        • Research Site
      • Yokohama, Japan, 241-8515
        • Research Site
  • Malaysia
      • Bandar Puncak Alam, Malaysia, 42300
        • Research Site
      • George Town, Malaysia, 10450
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Research Site
      • Kuala Selangor, Malaysia, 62250
        • Research Site
      • Kuching, Malaysia, 93586
        • Research Site
  • Mexico
      • Guadalajara, Jalisco, Mexico, 44280
        • Research Site
      • México, Mexico, 1400
        • Research Site
      • San Luis Potosí City, Mexico, 78209
        • Research Site
      • Tuxtla Gutiérrez, Mexico, 29090
        • Research Site
  • Philippines
      • Davao City, Philippines, 8000
        • Research Site
      • Makati, Philippines, 1229
        • Research Site
      • Manila, Philippines, 1003
        • Research Site
      • Pasig, Philippines, 1600
        • Research Site
      • Quezon City, Philippines, 1112
        • Research Site
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Research Site
      • Vila Real, Portugal, 5000-508
        • Research Site
  • Puerto Rico
      • Hato Rey Central, Puerto Rico, 00917
        • Research Site
      • San Juan, Puerto Rico, 00927
        • Research Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 22384
        • Research Site
      • Riyadh, Saudi Arabia, 12713
        • Research Site
  • South Korea
      • Busan, South Korea, 49241
        • Research Site
      • Daegu, South Korea, 42601
        • Research Site
      • Goyang-si, South Korea, 10408
        • Research Site
      • Junggu, South Korea, 41944
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 06351
        • Research Site
  • Spain
      • Barcelona, Spain, 08036
        • Research Site
      • Córdoba, Spain, 14004
        • Research Site
      • Donostia / San Sebastian, Spain, 20014
        • Research Site
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
      • Taipei, Taiwan, TAIWAN
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10210
        • Research Site
      • Bangkok, Thailand, 10300
        • Research Site
      • Bangkok, Thailand, 10400
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Research Site
      • Mobile, Alabama, United States, 36607
        • Research Site
    • Arizona
      • Yuma, Arizona, United States, 85364
        • Research Site
    • California
      • Glendale, California, United States, 91204
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Research Site
    • New York
      • Commack, New York, United States, 11725
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site
      • Ho Chi Minh City, Vietnam, 70000
        • Research Site
      • Hà Nội, Vietnam, 100000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
Drug: Tremelimumab
Tremelimumab IV (intravenous)
Other Names:
  • MEDI1123
Drug: Durvalumab
Durvalumab IV (intravenous)
Other Names:
  • MEDI4736
Procedure: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Other Names:
  • DEB-TACE and cTACE
Drug: Lenvatinib
Lenvatinib (oral)
Other Names:
  • Lenvima
Experimental: Arm B
Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
Drug: Tremelimumab
Tremelimumab IV (intravenous)
Other Names:
  • MEDI1123
Drug: Durvalumab
Durvalumab IV (intravenous)
Other Names:
  • MEDI4736
Procedure: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Other Names:
  • DEB-TACE and cTACE
Active Comparator: Arm C
Transarterial Chemoembolization (TACE)
Procedure: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Other Names:
  • DEB-TACE and cTACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 5 years
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
Approximately 5 years
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
Approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

February 23, 2026

Study Completion (Estimated)

February 26, 2027

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D910VC00001
  • 2021-003822-54 (EudraCT Number)
  • 2023-508701-24-00 (Registry Identifier: CITS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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