Back to resultsAssess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment (EMERALD-2)
Primary Purpose
Hepatocellular Carcinoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Bevacizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Early stage HCC, Durvalumab, Bevacizumab, Liver Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
- Imaging to confirm disease-free status within 28 days prior to randomization
- ECOG 0-1 at enrolment
- Child-Pugh score of 5 or 6
- Adequate organ and marrow function.
Exclusion Criteria:
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
- History of hepatic encephalopathy within 12 months prior to randomization
- Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
- Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
- Active co-infection with HBV and HDV.
- Receipt of prior systemic anticancer therapy for HCC
- Those on a waiting list for liver transplantation
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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
Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)
Outcomes
Primary Outcome Measures
Recurrence-free survival (RFS) for Arm A vs Arm C
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Secondary Outcome Measures
Recurrence-free survival (RFS) Arm B vs Arm C
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C
OS is defined as the time from the date of randomization until death due to any cause
Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C
Proportion of RFS at 24 months and at 36 months
Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C
TTR is defined as the time from the date of randomization until the date of disease recurrence
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03847428
Brief Title
Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
Acronym
EMERALD-2
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (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 assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
Detailed Description
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Early stage HCC, 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
908 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
Arm Title
Arm C
Arm Type
Placebo Comparator
Arm Description
Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
IMFINZI
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) or Dextrose for Durvalumab masking
Primary Outcome Measure Information:
Title
Recurrence-free survival (RFS) for Arm A vs Arm C
Description
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Time Frame
Up to 49 months after first patient randomized
Secondary Outcome Measure Information:
Title
Recurrence-free survival (RFS) Arm B vs Arm C
Description
RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Time Frame
Up to 49 months after first patient randomized
Title
Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C
Description
OS is defined as the time from the date of randomization until death due to any cause
Time Frame
No timeframe
Title
Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C
Description
Proportion of RFS at 24 months and at 36 months
Time Frame
At 24 and at 36 months
Title
Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C
Description
TTR is defined as the time from the date of randomization until the date of disease recurrence
Time Frame
Up to 49 months after first patient randomized
Title
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C
Description
Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)
Time Frame
Up to 49 months after first patient randomized
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
150 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
Imaging to confirm disease-free status within 28 days prior to randomization
ECOG 0-1 at enrolment
Child-Pugh score of 5 or 6
Adequate organ and marrow function.
Exclusion Criteria:
Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
History of hepatic encephalopathy within 12 months prior to randomization
Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
Active co-infection with HBV and HDV.
Receipt of prior systemic anticancer therapy for HCC
Those on a waiting list for liver transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Fan, PhD
Organizational Affiliation
Liver Cancer Institute Zhongshan Hospital, Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Knox, MD
Organizational Affiliation
Solid Tumor Medical Oncology Princess Margaret Cancer Centre
Official's Role
Principal Investigator
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City
Birmingham
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Alabama
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35233
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United States
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Mobile
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United States
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Phoenix
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La Jolla
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Louisville
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3100
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Florianópolis
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88034-000
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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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Rio de Janeiro
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20231-050
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Santa Maria
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09060-870
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São José do Rio Preto
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Toronto
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Quebec
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Beijing
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100021
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China
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Beijing
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100142
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China
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Beijing
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100730
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Bengbu
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Changchun
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Changsha
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Chengdu
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Guangzhou
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Guangzhou
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Hangzhou
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Hangzhou
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Hangzhou
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Harbin
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010017
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Nanjing
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Alexandria
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Assiut
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Cairo
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Cairo
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11588
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Cairo
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New Cairo
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32511
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Amiens Cedex 1
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88054
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France
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ANGERS Cedex 9
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49933
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France
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Besançon
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25000
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France
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Clichy
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21079
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Nantes
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44093
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France
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Nice
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06200
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France
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PARIS Cedex 12
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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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31059
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France
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TOURS Cedex 9
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37049
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France
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Berlin
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13353
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Germany
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Bonn
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53105
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Germany
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Chemnitz
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09116
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Germany
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Freiburg
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Germany
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Heidelberg
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69120
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Germany
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Köln
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Germany
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Leipzig
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Germany
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Lübeck
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Germany
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München
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Germany
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Tuebingen
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Hong Kong
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Hong Kong
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Hong Kong
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HongKong
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Hong Kong
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Bangalore
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560027
Country
India
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560092
Country
India
Facility Name
Research Site
City
Hyderabad
ZIP/Postal Code
500032
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700160
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Tricase, Lecce
ZIP/Postal Code
73039
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Research Site
City
Gifu-shi
ZIP/Postal Code
500-8513
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Kumamoto-shi
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Research Site
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Research Site
City
Matsuyama-shi
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
Research Site
City
Mitaka-shi
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Research Site
City
Musashino-shi
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Research Site
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
467-0001
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
541-8567
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
543-8555
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
Sapporo-shi
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-0872
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Research Site
City
Shiwa-gun
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Research Site
City
Takasaki-shi
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
Research Site
City
Tsu-shi
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Research Site
City
Wakayama-shi
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
245-8575
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
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
Lima
ZIP/Postal Code
LIMA 31
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 41
Country
Peru
Facility Name
Research Site
City
San Isidro
ZIP/Postal Code
27
Country
Peru
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Research Site
City
Muntinlupa City
ZIP/Postal Code
1780
Country
Philippines
Facility Name
Research Site
City
Pasig City
ZIP/Postal Code
1605
Country
Philippines
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Research Site
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
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
Moscow
ZIP/Postal Code
119421
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249031
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197044
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
329563
Country
Singapore
Facility Name
Research Site
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
710
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
Yunlin
ZIP/Postal Code
640
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
10330
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
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
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
6200
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Malatya
ZIP/Postal Code
44100
Country
Turkey
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
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Research Site
City
Hochiminh
ZIP/Postal Code
70000
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 rerefer 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
Learn more about this trial
Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
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