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Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment (EMERALD-2)

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ClinicalTrials.gov Identifier: NCT03847428
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Durvalumab Drug: Bevacizumab Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 888 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, 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
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : June 29, 2022
Estimated Study Completion Date : June 16, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
Drug: Durvalumab
Durvalumab IV (intravenous)
Other Name: IMFINZI

Drug: Bevacizumab
Bevacizumab IV (intravenous)
Other Name: AVASTIN

Experimental: Arm B
Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
Drug: Durvalumab
Durvalumab IV (intravenous)
Other Name: IMFINZI

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

Placebo Comparator: Arm C
Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)
Other: Placebo
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)




Primary Outcome Measures :
  1. Recurrence-free survival (RFS) for Arm B vs Arm C [ Time Frame: Up to 38 months after first patient randomized ]
    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 :
  1. Recurrence-free survival (RFS) Arm A vs Arm C [ Time Frame: Up to 38 months after first patient randomized ]
    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.

  2. Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: Up to 48 months (OS48) after first patient randomized ]
    OS is defined as the time from the date of randomization until death due to any cause

  3. Recurrence-free survival at 24 months (RFS24) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: Up to 24 months ]
    Proportion of RFS at 24 months

  4. Recurrence-free survival at 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: Up to 36 months ]
    Proportion of RFS at 36 months

  5. Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: Up to 38 months after first patient randomized ]
    TTR is defined as the time from the date of randomization until the date of disease recurrence

  6. Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: Up to 38 months after first patient randomized ]
    Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)



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Ages Eligible for Study:   18 Years to 150 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically 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

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
  • Evidence of portal vein thrombosis
  • Receipt of prior systemic anticancer therapy for HCC
  • Those on a waiting list for liver transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847428


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

  Show 160 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Jia Fan, PhD Liver Cancer Institute Zhongshan Hospital, Fudan University
Principal Investigator: Jennifer Knox, MD Solid Tumor Medical Oncology Princess Margaret Cancer Centre

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03847428     History of Changes
Other Study ID Numbers: D910DC00001
2018-004105-85 ( EudraCT Number )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AstraZeneca:
Early stage HCC
Durvalumab
Bevacizumab
Liver Cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Bevacizumab
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors