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

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ClinicalTrials.gov Identifier: NCT03778957
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 28, 2018
First Posted Date  ICMJE December 19, 2018
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE November 30, 2018
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03778957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • 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
  • 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
  • Health status/quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-30) [ 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
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: December 17, 2018)
  • Safety of Durvalumab and Bevacizumab as evaluated by summary of adverse events by treatment arm and CTCAE grade [ Time Frame: Approximately 5 years ]
  • Immunogenicity of Durvalumab and Bevacizumab as measured by presence of anti-drug antibodies (ADAs) [ Time Frame: Approximately 5 years ]
  • Pharmacokinetics (PK) of Durvalumab and Bevacizumab as determined by peak serum concentrations [ Time Frame: Approximately 5 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
Official Title  ICMJE 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)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: Durvalumab
    Durvalumab IV (intravenous)
    Other Name: MEDI4736
  • Drug: Bevacizumab
    Bevacizumab IV (intravenous)
    Other Name: AVASTIN
  • 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)
Study Arms  ICMJE
  • Experimental: Arm A
    Transarterial Chemoembolization (TACE) in combination with Durvalumab
    Interventions:
    • Drug: Durvalumab
    • Other: Placebo
    • Procedure: Transarterial Chemoembolization (TACE)
  • Experimental: Arm B
    Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
    Interventions:
    • Drug: Durvalumab
    • Drug: Bevacizumab
    • Procedure: Transarterial Chemoembolization (TACE)
  • Placebo Comparator: Arm C
    Transarterial Chemoembolization (TACE) in combination with Placebos
    Interventions:
    • Other: Placebo
    • Procedure: Transarterial Chemoembolization (TACE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 29, 2023
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Canada,   Mexico,   Australia,   Brazil,   China,   France,   Hong Kong,   India,   Italy,   Japan,   Korea, Republic of,   Russian Federation,   Spain,   Taiwan,   Thailand,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03778957
Other Study ID Numbers  ICMJE D933GC00001
2018-002134-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruno Sangro, MD Clinica Universidad de Navarra
Principal Investigator: Riccardo Lencioni, MD FSIR EBIR University of Pisa / Miami Cancer Institute
PRS Account AstraZeneca
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP