A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)

February 26, 2024 updated by: AstraZeneca

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter, global Phase III study to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in combination with durvalumab monotherapy or TACE given with durvalumab plus bevacizumab therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma not amenable to curative therapy

Study Type

Interventional

Enrollment (Actual)

724

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

  • Australia
      • Benowa, Australia, 4217
        • Research Site
      • Box Hill, Australia, 3128
        • Research Site
      • Camperdown, Australia, 2050
        • Research Site
      • Clayton, Australia, 3168
        • Research Site
      • Herston, Australia, 4029
        • Research Site
      • Liverpool, Australia, 2170
        • Research Site
      • Melbourne, Australia, 3004
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Florianópolis, Brazil, 88034-000
        • Research Site
      • Porto Alegre, Brazil, 90035-003
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Porto Alegre, Brazil, 90020-090
        • Research Site
      • Rio de Janeiro, Brazil, 20231-050
        • Research Site
      • Santa Maria, Brazil, 97015-450
        • Research Site
      • Sao Paulo, Brazil, 01323-903
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Research Site
      • Vitória, Brazil, 29043-272
        • Research Site
  • Canada
    • Ontario
      • 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, 100021
        • Research Site
      • Beijing, China, 100730
        • Research Site
      • Beijing, China, 100036
        • Research Site
      • Beijing, China, 100069
        • Research Site
      • Changchun, China, 130021
        • Research Site
      • Changsha, China, 410013
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Fuzhou, China, 350025
        • Research Site
      • Fuzhou, China, 350005
        • Research Site
      • Guangzhou, China, 510080
        • Research Site
      • Guangzhou, China, 510060
        • Research Site
      • Guangzhou, China, 510515
        • Research Site
      • Hangzhou, China, 310022
        • Research Site
      • Harbin, China, 150081
        • Research Site
      • Hefei, China, 230001
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Nanjing, China, 210002
        • Research Site
      • Nanjing, China, 210009
        • Research Site
      • Nantong, China, 226361
        • Research Site
      • Neijiang, China, 641100
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 201508
        • Research Site
      • Shenyang, China, 110001
        • Research Site
      • Shenzhen, China, 518053
        • Research Site
      • Tianjin, China, 300170
        • Research Site
      • Wuhan, China, 430079
        • Research Site
      • Wuhan, China, 430010
        • Research Site
      • Xi'an, China, 710061
        • Research Site
      • Zhengzhou, China, 450008
        • Research Site
      • Zhuhai, China, 519000
        • Research Site
  • France
      • Bobigny, France, 93000
        • Research Site
      • Clichy, France, 92210
        • Research Site
      • Grenoble cedex 9, France, 38043
        • Research Site
      • Montpellier CEDEX 5, France, 34295
        • Research Site
      • Nice Cedex 3, France, 06202
        • Research Site
      • Paris Cedex 13, France, 75651
        • Research Site
      • Pessac, France, 33604
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
      • Vandoeuvre Les Nancy, France, 54511
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • Shatin, Hong Kong, 00000
        • Research Site
  • India
      • Bangalore, India, 560068
        • Research Site
      • Bengaluru, India, 560076
        • Research Site
      • Hyderabad, India, 500004
        • Research Site
      • Kolkata, India, 700160
        • Research Site
      • Kolkata, India, 700054
        • Research Site
      • Madurai, India, 625107
        • Research Site
      • Mumbai, India, 400 012
        • Research Site
      • Nashik, India, 422002
        • Research Site
      • Pune, India, 411004
        • Research Site
      • Surat, India, 395002
        • Research Site
      • Vijayawada, India, 520002
        • Research Site
      • Vishakhapatnam, India, 530017
        • Research Site
  • Italy
      • Arezzo, Italy, 52100
        • Research Site
      • Brescia, Italy, 25100
        • Research Site
      • Milano, Italy, 20132
        • Research Site
      • Milano, Italy, 20133
        • Research Site
      • Pisa, Italy, 56124
        • Research Site
  • Japan
      • Bunkyo-ku, Japan, 113-8655
        • Research Site
      • Chiba-shi, Japan, 260-8677
        • Research Site
      • Chuo-ku, Japan, 104-0045
        • Research Site
      • Fukuoka-shi, Japan, 810-8563
        • Research Site
      • Hiroshima-shi, Japan, 734-8551
        • Research Site
      • Kurume-shi, Japan, 830-0011
        • Research Site
      • Musashino-shi, Japan, 180-8610
        • Research Site
      • Nagoya-shi, Japan, 464-8681
        • Research Site
      • Okayama, Japan, 700-8558
        • Research Site
      • Osaka-shi, Japan, 545-8586
        • Research Site
      • Osaka-shi, Japan, 534-0021
        • Research Site
      • Osakasayama-shi, Japan, 589-8511
        • Research Site
      • Sapporo-shi, Japan, 006-8555
        • Research Site
      • Shiwa-gun, Japan, 028-3695
        • Research Site
      • Tsu-shi, Japan, 514-8507
        • Research Site
      • Yokohama-shi, Japan, 241-8515
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Research Site
      • Daegu, Korea, Republic of, 41944
        • Research Site
      • Goyang-si, Korea, Republic of, 10408
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Research Site
  • Mexico
      • Alc. Cuauhtémoc, Mexico, 06100
        • Research Site
      • Culiacan, Mexico, 80230
        • Research Site
      • Guadalajara, Mexico, 44280
        • Research Site
      • Mexico, Mexico, 14080
        • Research Site
      • Monterrey, Mexico, 64460
        • Research Site
      • Monterrey, Mexico, 64710
        • Research Site
      • Mérida, Mexico, 97134
        • Research Site
      • Tuxtla Gutierrez, Mexico, 29090
        • Research Site
  • Russian Federation
      • Barnaul, Russian Federation, 656049
        • Research Site
      • Ekaterinburg, Russian Federation, 620905
        • Research Site
      • Kazan, Russian Federation, 420029
        • Research Site
      • Moscow, Russian Federation, 115478
        • Research Site
      • Novosibirsk, Russian Federation, 630007
        • Research Site
      • Obninsk, Russian Federation, 249031
        • Research Site
      • Sankt-Peterburg, Russian Federation, 197758
        • Research Site
      • St. Petersburg, Russian Federation, 197758
        • Research Site
  • Singapore
      • Bukit Merah, Singapore, 169610
        • Research Site
  • Spain
      • Córdoba, Spain, 14004
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Pamplona, Spain, 31008
        • Research Site
      • San Sebastián(Guipuzcoa), Spain, 20014
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Research Site
      • Liou Ying Township, Taiwan, 736
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 404
        • Research Site
      • Tainan City, Taiwan, 704
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
      • Taoyuan City, Taiwan, 333
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10210
        • Research Site
      • Bangkok, Thailand, 10300
        • Research Site
      • Bangkok, Thailand, 10400
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Phisanulok, Thailand, 65000
        • Research Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Research Site
      • Tucson, Arizona, United States, 85724
        • Research Site
    • California
      • Costa Mesa, California, United States, 92627
        • Research Site
      • La Jolla, California, United States, 92093-0698
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Research Site
      • Miami, Florida, United States, 33176
        • Research Site
      • Miami, Florida, United States, 33136
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Research Site
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Research Site
    • New York
      • Stony Brook, New York, United States, 11794
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Research Site
      • Durham, North Carolina, United States, 27710
        • Research Site
      • Winston-Salem, North Carolina, United States, 27157
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Research Site
      • Memphis, Tennessee, United States, 38104
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Research Site
      • Dallas, Texas, United States, 75216
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Houston, Texas, United States, 77090
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Hanoi, Vietnam, 123
        • Research Site
      • Ho Chi Minh, Vietnam, 700000
        • Research Site
      • Ho Chi Minh City, Vietnam, 70000
        • 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 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key 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 to B7 and 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

Key Exclusion Criteria

  • Any history of nephrotic or nephritic syndrome
  • Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization
  • Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)
  • History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
  • Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Transarterial Chemoembolization (TACE) in combination with Durvalumab
Drug: Durvalumab
Durvalumab IV (intravenous)
Other Names:
  • MEDI4736
Procedure: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Other: Placebo
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
Experimental: Arm B
Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
Drug: Durvalumab
Durvalumab IV (intravenous)
Other Names:
  • MEDI4736
Procedure: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Drug: Bevacizumab
Bevacizumab IV (intravenous)
Other Names:
  • AVASTIN
Placebo Comparator: Arm C
Transarterial Chemoembolization (TACE) in combination with Placebos
Procedure: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Other: Placebo
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) for Arm B vs Arm C
Time Frame: Approximately 5 years
PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death
Approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) for Arm A vs Arm C
Time Frame: Approximately 5 years
PFS per Blinded Independent Central Review (BICR) assessment will be defined as the time from the date of randomization until the date of first objective disease progression or death
Approximately 5 years
Overall Survival (OS)
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
Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30)
Time Frame: Approximately 5 years
Collection of patient reported outcome (PRO) measures to assess time to deterioration in global health status/quality of life (QoL), functioning (physical) and symptoms
Approximately 5 years
Disease-related symptoms measured by European Organization for Research and Treatment of Cancer (EORTC) 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18)
Time Frame: Approximately 5 years
Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms
Approximately 5 years

Other Outcome Measures

Outcome Measure
Time Frame
Safety of Durvalumab and Bevacizumab as evaluated by summary of adverse events by treatment arm and CTCAE grade
Time Frame: Approximately 5 years
Approximately 5 years
Immunogenicity of Durvalumab and Bevacizumab as measured by presence of anti-drug antibodies (ADAs)
Time Frame: Approximately 5 years
Approximately 5 years
Pharmacokinetics (PK) of Durvalumab and Bevacizumab as determined by peak serum concentrations
Time Frame: Approximately 5 years
Approximately 5 years

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Bruno Sangro, MD, Clinica Universidad de Navarra
  • Principal Investigator: Riccardo Lencioni, MD FSIR EBIR, University of Pisa / Miami Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 30, 2018

Primary Completion (Actual)

September 11, 2023

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D933GC00001
  • 2018-002134-20 (EudraCT Number)

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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