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

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03778957
Collaborator
(none)
724
Enrollment
183
Locations
3
Arms
68.6
Anticipated Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
724 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Nov 30, 2018
Anticipated Primary Completion Date :
Sep 19, 2022
Anticipated Study Completion Date :
Aug 19, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Transarterial Chemoembolization (TACE) in combination with Durvalumab

Drug: Durvalumab
Durvalumab IV (intravenous)
Other Names:
  • MEDI4736

    • Other: Placebo
    Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)

    Procedure: Transarterial Chemoembolization (TACE)
    TACE (chemo and embolic agent injection into the hepatic artery)
    Experimental: Arm B

    Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab

    Drug: Durvalumab
    Durvalumab IV (intravenous)
    Other Names:
  • MEDI4736

    • Drug: Bevacizumab
    Bevacizumab IV (intravenous)
    Other Names:
  • AVASTIN

    • Procedure: Transarterial Chemoembolization (TACE)
    TACE (chemo and embolic agent injection into the hepatic artery)
    Placebo Comparator: Arm C

    Transarterial Chemoembolization (TACE) in combination with Placebos

    Other: Placebo
    Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)

    Procedure: Transarterial Chemoembolization (TACE)
    TACE (chemo and embolic agent injection into the hepatic artery)

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) for Arm B vs Arm C [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

    Secondary Outcome Measures

    1. Progression Free Survival (PFS) for Arm A vs Arm C [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

    2. Overall Survival (OS) [Approximately 5 years]

      OS is defined as the time from the date of randomization until death due to any cause

    3. 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) [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

    4. 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) [Approximately 5 years]

      Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms

    Other Outcome Measures

    1. Safety of Durvalumab and Bevacizumab as evaluated by summary of adverse events by treatment arm and CTCAE grade [Approximately 5 years]

    2. Immunogenicity of Durvalumab and Bevacizumab as measured by presence of anti-drug antibodies (ADAs) [Approximately 5 years]

    3. Pharmacokinetics (PK) of Durvalumab and Bevacizumab as determined by peak serum concentrations [Approximately 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Mobile Alabama United States 36604
    2 Research Site Phoenix Arizona United States 85054
    3 Research Site Tucson Arizona United States 85724
    4 Research Site Costa Mesa California United States 92627
    5 Research Site La Jolla California United States 92093-0698
    6 Research Site Orange California United States 92868
    7 Research Site Aurora Colorado United States 80045
    8 Research Site Washington District of Columbia United States 20007
    9 Research Site Jacksonville Florida United States 32224
    10 Research Site Miami Florida United States 33136
    11 Research Site Miami Florida United States 33176
    12 Research Site Honolulu Hawaii United States 96819
    13 Research Site Chicago Illinois United States 60612
    14 Research Site Indianapolis Indiana United States 46202
    15 Research Site Westwood Kansas United States 66205
    16 Research Site Shreveport Louisiana United States 71103
    17 Research Site Boston Massachusetts United States 02114
    18 Research Site Boston Massachusetts United States 02215
    19 Research Site Detroit Michigan United States 48201
    20 Research Site Rochester Minnesota United States 55905-0001
    21 Research Site Saint Louis Missouri United States 63110
    22 Research Site Omaha Nebraska United States 68198
    23 Research Site Stony Brook New York United States 11794
    24 Research Site Charlotte North Carolina United States 28204
    25 Research Site Durham North Carolina United States 27710
    26 Research Site Winston-Salem North Carolina United States 27157
    27 Research Site Cleveland Ohio United States 44106
    28 Research Site Portland Oregon United States 97213
    29 Research Site Philadelphia Pennsylvania United States 19104
    30 Research Site Pittsburgh Pennsylvania United States 15212
    31 Research Site Sioux Falls South Dakota United States 57105
    32 Research Site Knoxville Tennessee United States 37920
    33 Research Site Memphis Tennessee United States 38104
    34 Research Site Dallas Texas United States 75216
    35 Research Site Dallas Texas United States 75235
    36 Research Site Dallas Texas United States 75390
    37 Research Site Houston Texas United States 77030
    38 Research Site Houston Texas United States 77090
    39 Research Site Morgantown West Virginia United States 26506
    40 Research Site Milwaukee Wisconsin United States 53226
    41 Research Site Benowa Australia 4217
    42 Research Site Box Hill Australia 3128
    43 Research Site Camperdown Australia 2050
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    45 Research Site Herston Australia 4029
    46 Research Site Liverpool Australia 2170
    47 Research Site Melbourne Australia 3004
    48 Research Site Barretos Brazil 14784-400
    49 Research Site Florianópolis Brazil 88034-000
    50 Research Site Porto Alegre Brazil 90020-090
    51 Research Site Porto Alegre Brazil 90035-003
    52 Research Site Porto Alegre Brazil 91350-200
    53 Research Site Rio de Janeiro Brazil 20231-050
    54 Research Site Santa Maria Brazil 97015-450
    55 Research Site Sao Paulo Brazil 01323-903
    56 Research Site São José do Rio Preto Brazil 15090-000
    57 Research Site Vitória Brazil 29043-272
    58 Research Site Ottawa Ontario Canada K1H 8L6
    59 Research Site Toronto Ontario Canada M4N 3M5
    60 Research Site Toronto Ontario Canada M5G 2M9
    61 Research Site Montreal Quebec Canada H2X 3E4
    62 Research Site Montreal Quebec Canada H4A 3J1
    63 Research Site Beijing China 100021
    64 Research Site Beijing China 100036
    65 Research Site Beijing China 100069
    66 Research Site Beijing China 100730
    67 Research Site Changchun China 130021
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    69 Research Site Chengdu China 610041
    70 Research Site Fuzhou China 350005
    71 Research Site Fuzhou China 350025
    72 Research Site Guangzhou China 510060
    73 Research Site Guangzhou China 510080
    74 Research Site Guangzhou China 510515
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    76 Research Site Harbin China 150081
    77 Research Site Hefei China 230001
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    79 Research Site Nanjing China 210002
    80 Research Site Nanjing China 210009
    81 Research Site Nantong China 226361
    82 Research Site Neijiang China 641100
    83 Research Site Shanghai China 200032
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    87 Research Site Tianjin China 300170
    88 Research Site Wuhan China 430010
    89 Research Site Wuhan China 430079
    90 Research Site Xi'an China 710061
    91 Research Site Zhengzhou China 450008
    92 Research Site Zhuhai China 519000
    93 Research Site Bobigny France 93000
    94 Research Site Clichy France 92210
    95 Research Site Grenoble cedex 9 France 38043
    96 Research Site Montpellier CEDEX 5 France 34295
    97 Research Site Nice Cedex 3 France 06202
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    99 Research Site Pessac France 33604
    100 Research Site Toulouse Cedex 9 France 31059
    101 Research Site Vandoeuvre Les Nancy France 54511
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    103 Research Site Shatin Hong Kong 00000
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    105 Research Site Bengaluru India 560076
    106 Research Site Hyderabad India 500004
    107 Research Site Kolkata India 700054
    108 Research Site Kolkata India 700160
    109 Research Site Madurai India 625107
    110 Research Site Mumbai India 400 012
    111 Research Site Nashik India 422002
    112 Research Site Pune India 411004
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    114 Research Site Vijayawada India 520002
    115 Research Site Vishakhapatnam India 530017
    116 Research Site Arezzo Italy 52100
    117 Research Site Brescia Italy 25100
    118 Research Site Milano Italy 20132
    119 Research Site Milano Italy 20133
    120 Research Site Pisa Italy 56124
    121 Research Site Bunkyo-ku Japan 113-8655
    122 Research Site Chiba-shi Japan 260-8677
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    125 Research Site Hiroshima-shi Japan 734-8551
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    129 Research Site Okayama Japan 700-8558
    130 Research Site Osaka-shi Japan 534-0021
    131 Research Site Osaka-shi Japan 545-8586
    132 Research Site Osakasayama-shi Japan 589-8511
    133 Research Site Sapporo-shi Japan 006-8555
    134 Research Site Shiwa-gun Japan 028-3695
    135 Research Site Tsu-shi Japan 514-8507
    136 Research Site Yokohama-shi Japan 241-8515
    137 Research Site Busan Korea, Republic of 49241
    138 Research Site Daegu Korea, Republic of 41944
    139 Research Site Goyang-si Korea, Republic of 10408
    140 Research Site Seoul Korea, Republic of 03080
    141 Research Site Seoul Korea, Republic of 03722
    142 Research Site Seoul Korea, Republic of 05505
    143 Research Site Seoul Korea, Republic of 06351
    144 Research Site Alc. Cuauhtémoc Mexico 06100
    145 Research Site Culiacan Mexico 80230
    146 Research Site Guadalajara Mexico 44280
    147 Research Site Mexico Mexico 14080
    148 Research Site Monterrey Mexico 64460
    149 Research Site Monterrey Mexico 64710
    150 Research Site Mérida Mexico 97134
    151 Research Site Tuxtla Gutierrez Mexico 29090
    152 Research Site Barnaul Russian Federation 656049
    153 Research Site Ekaterinburg Russian Federation 620905
    154 Research Site Kazan Russian Federation 420029
    155 Research Site Moscow Russian Federation 115478
    156 Research Site Novosibirsk Russian Federation 630007
    157 Research Site Obninsk Russian Federation 249031
    158 Research Site Sankt-Peterburg Russian Federation 197758
    159 Research Site St. Petersburg Russian Federation 197758
    160 Research Site Bukit Merah Singapore 169610
    161 Research Site Córdoba Spain 14004
    162 Research Site Madrid Spain 28007
    163 Research Site Pamplona Spain 31008
    164 Research Site San Sebastián(Guipuzcoa) Spain 20014
    165 Research Site Kaohsiung Taiwan 833
    166 Research Site Liou Ying Township Taiwan 736
    167 Research Site Taichung Taiwan 404
    168 Research Site Taichung Taiwan 40705
    169 Research Site Tainan City Taiwan 704
    170 Research Site Taipei Taiwan 10002
    171 Research Site Taipei Taiwan 11217
    172 Research Site Taoyuan City Taiwan 333
    173 Research Site Bangkok Thailand 10210
    174 Research Site Bangkok Thailand 10300
    175 Research Site Bangkok Thailand 10400
    176 Research Site Chiang Mai Thailand 50200
    177 Research Site Hat Yai Thailand 90110
    178 Research Site Khon Kaen Thailand 40002
    179 Research Site Phisanulok Thailand 65000
    180 Research Site Hanoi Vietnam 100000
    181 Research Site Hanoi Vietnam 123
    182 Research Site Ho Chi Minh City Vietnam 70000
    183 Research Site Ho Chi Minh Vietnam 700000

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03778957
    Other Study ID Numbers:
    • D933GC00001
    • 2018-002134-20
    First Posted:
    Dec 19, 2018
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    Hepatocellular Carcinoma
    TACE
    Durvalumab
    Bevacizumab
    Liver Cancer
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Bevacizumab
    Durvalumab

    Study Results

    No Results Posted as of Aug 25, 2022