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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 18, 2018
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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
Hepatocellular Carcinoma Drug: Durvalumab Drug: Bevacizumab Other: Placebo Procedure: Transarterial Chemoembolization (TACE) Phase 3

Detailed Description:
This is a randomized, double-blind, placebo-controlled, multi-center, 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : November 29, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
Transarterial Chemoembolization (TACE) in combination with Durvalumab
Drug: Durvalumab
Durvalumab IV (intravenous)
Other Name: 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 Name: MEDI4736

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  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-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

  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) [ Time Frame: 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 [ Time Frame: Approximately 5 years ]
  2. Immunogenicity of Durvalumab and Bevacizumab as measured by presence of anti-drug antibodies (ADAs) [ Time Frame: Approximately 5 years ]
  3. Pharmacokinetics (PK) of Durvalumab and Bevacizumab as determined by peak serum concentrations [ Time Frame: Approximately 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • No evidence of extrahepatic disease on baseline imaging
  • 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
  • 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

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): NCT03778957


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

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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Bruno Sangro, MD Clinica Universidad de Navarra
Principal Investigator: Riccardo Lencioni, MD FSIR EBIR University of Pisa / Miami Cancer Institute

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03778957     History of Changes
Other Study ID Numbers: D933GC00001
2018-002134-20 ( EudraCT Number )
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

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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:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Bevacizumab
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors