Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC (EMERALD-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05301842
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Tremelimumab Drug: Durvalumab Procedure: Transarterial Chemoembolization (TACE) Drug: Lenvatinib Phase 3

Detailed Description:
This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Open-label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination With Tremelimumab ± Lenvatinib Given Concurrently With TACE Compared to TACE Alone in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-3)
Actual Study Start Date : March 28, 2022
Estimated Primary Completion Date : October 30, 2025
Estimated Study Completion Date : January 29, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Arm A
Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
 Drug: Tremelimumab
Tremelimumab IV (intravenous)
Other Name: MEDI1123

Drug: Durvalumab
Durvalumab IV (intravenous)
Other Name: MEDI4736

Procedure: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Other Name: DEB-TACE and cTACE

Drug: Lenvatinib
Lenvatinib (oral)
Other Name: Lenvima
Experimental: Arm B
Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
 Drug: Tremelimumab
Tremelimumab IV (intravenous)
Other Name: MEDI1123

Drug: Durvalumab
Durvalumab IV (intravenous)
Other Name: MEDI4736

Procedure: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Other Name: DEB-TACE and cTACE
Active Comparator: Arm C
Transarterial Chemoembolization (TACE)
 Procedure: Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)
Other Name: DEB-TACE and cTACE


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression Free Survival (PFS) for Arm A vs Arm C [ Time Frame: Approximately 5 years ]
    PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) for Arm B vs Arm C [ Time Frame: Approximately 5 years ]
    PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause

  2. Overall Survival (OS) for Arm A vs Arm C [ Time Frame: Approximately 5 years ]
    OS is defined as the time from the date of randomization until death due to any cause

  3. Overall Survival (OS) for Arm B vs Arm C [ Time Frame: Approximately 5 years ]
    OS is defined as the time from the date of randomization until death due to any cause


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Exclusion Criteria:

  • History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia
  • History of hepatic encephalopathy
  • Major portal vein thrombosis visible on baseline imaging
  • Uncontrolled arterial hypertension
  • Co-infection with HBV and HDV
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05301842


Contacts
Layout table for location contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Show Show 183 study locations
Sponsors and Collaborators
AstraZeneca
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05301842    
Other Study ID Numbers: D910VC00001
2021-003822-54 ( EudraCT Number )
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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 refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Hepatocellular Carcinoma
Locoregional HCC
Durvalumab
Tremelimumab
 Lenvatinib
TACE
Liver Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Durvalumab
Lenvatinib
Tremelimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action