Back to resultsA Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)
Primary Purpose
Hepatocellular Carcinoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Bevacizumab
Placebo
Transarterial Chemoembolization (TACE)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, TACE, Durvalumab, Bevacizumab, Liver Cancer
Eligibility Criteria
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
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Arm A
Arm B
Arm C
Arm Description
Transarterial Chemoembolization (TACE) in combination with Durvalumab
Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
Transarterial Chemoembolization (TACE) in combination with Placebos
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) for Arm B vs Arm C
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
Secondary Outcome Measures
Progression Free Survival (PFS) for Arm A vs Arm C
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
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause
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)
Collection of patient reported outcome (PRO) measures to assess time to deterioration in global health status/quality of life (QoL), functioning (physical) and symptoms
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)
Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03778957
Brief Title
A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
Acronym
EMERALD-1
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
September 11, 2023 (Actual)
Study Completion Date
August 19, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, TACE, Durvalumab, Bevacizumab, Liver Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
724 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Transarterial Chemoembolization (TACE) in combination with Durvalumab
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
Arm Title
Arm C
Arm Type
Placebo Comparator
Arm Description
Transarterial Chemoembolization (TACE) in combination with Placebos
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab IV (intravenous)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
AVASTIN
Intervention Description
Bevacizumab IV (intravenous)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
Intervention Type
Procedure
Intervention Name(s)
Transarterial Chemoembolization (TACE)
Intervention Description
TACE (chemo and embolic agent injection into the hepatic artery)
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) for Arm B vs Arm C
Description
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
Time Frame
Approximately 5 years
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) for Arm A vs Arm C
Description
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
Time Frame
Approximately 5 years
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization until death due to any cause
Time Frame
Approximately 5 years
Title
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)
Description
Collection of patient reported outcome (PRO) measures to assess time to deterioration in global health status/quality of life (QoL), functioning (physical) and symptoms
Time Frame
Approximately 5 years
Title
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)
Description
Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms
Time Frame
Approximately 5 years
Other Pre-specified Outcome Measures:
Title
Safety of Durvalumab and Bevacizumab as evaluated by summary of adverse events by treatment arm and CTCAE grade
Time Frame
Approximately 5 years
Title
Immunogenicity of Durvalumab and Bevacizumab as measured by presence of anti-drug antibodies (ADAs)
Time Frame
Approximately 5 years
Title
Pharmacokinetics (PK) of Durvalumab and Bevacizumab as determined by peak serum concentrations
Time Frame
Approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Sangro, MD
Organizational Affiliation
Clinica Universidad de Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Riccardo Lencioni, MD FSIR EBIR
Organizational Affiliation
University of Pisa / Miami Cancer Institute
Official's Role
Principal Investigator
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Mobile
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United States
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Phoenix
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Dallas
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Houston
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Houston
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4217
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3128
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Camperdown
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Clayton
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Herston
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Liverpool
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Melbourne
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3004
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Florianópolis
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Porto Alegre
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90020-090
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Porto Alegre
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90035-003
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Porto Alegre
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Rio de Janeiro
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Toronto
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Ontario
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Montreal
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Montreal
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Beijing
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100021
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Beijing
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Beijing
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100069
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China
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Beijing
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Changchun
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Fuzhou
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350005
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Fuzhou
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350025
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China
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Guangzhou
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Guangzhou
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510080
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Guangzhou
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Hangzhou
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Harbin
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150081
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Hefei
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Nanchang
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Nanjing
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Wuhan
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Wuhan
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Zhengzhou
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Zhuhai
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Bobigny
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93000
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France
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Grenoble cedex 9
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38043
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France
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Montpellier CEDEX 5
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France
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Nice Cedex 3
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France
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Paris Cedex 13
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France
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Pessac
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33604
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France
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Toulouse Cedex 9
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France
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Vandoeuvre Les Nancy
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France
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Hong Kong
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Hong Kong
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Shatin
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Hong Kong
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Bangalore
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India
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Bengaluru
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560076
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India
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Hyderabad
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500004
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India
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Kolkata
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India
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Kolkata
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India
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Madurai
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India
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Pune
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Surat
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India
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India
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India
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Arezzo
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Italy
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Brescia
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Italy
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Milano
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City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Research Site
City
Chiba-shi
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Research Site
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Research Site
City
Musashino-shi
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Research Site
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Research Site
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
006-8555
Country
Japan
Facility Name
Research Site
City
Shiwa-gun
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Research Site
City
Tsu-shi
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Alc. Cuauhtémoc
ZIP/Postal Code
06100
Country
Mexico
Facility Name
Research Site
City
Culiacan
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Research Site
City
Mérida
ZIP/Postal Code
97134
Country
Mexico
Facility Name
Research Site
City
Tuxtla Gutierrez
ZIP/Postal Code
29090
Country
Mexico
Facility Name
Research Site
City
Barnaul
ZIP/Postal Code
656049
Country
Russian Federation
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620905
Country
Russian Federation
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249031
Country
Russian Federation
Facility Name
Research Site
City
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Bukit Merah
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
San Sebastián(Guipuzcoa)
ZIP/Postal Code
20014
Country
Spain
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Research Site
City
Liou Ying Township
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10210
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Research Site
City
Phisanulok
ZIP/Postal Code
65000
Country
Thailand
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
123
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh City
ZIP/Postal Code
70000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
32557715
Citation
Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. No abstract available.
Results Reference
derived
Learn more about this trial
A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
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