Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

Hepatocellular Carcinoma Clinical Trial

— EMERALD-3  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05301842
• Other study ID #: D910VC00001
• Secondary ID: 2021-003822-54
• Status: Recruiting
• Phase: Phase 3
• Start date: March 28, 2022
• Est. completion date: February 26, 2027

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 725
• Est. completion date: February 26, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Tremelimumab
Tremelimumab IV (intravenous)
• Durvalumab
Durvalumab IV (intravenous)

Procedure:
• Transarterial Chemoembolization (TACE)
TACE (chemo and embolic agent injection into the hepatic artery)

Drug:
• Lenvatinib
Lenvatinib (oral)

Locations

Country	Name	City	State
Belgium	Research Site	Brussels
Belgium	Research Site	Gent
Brazil	Research Site	Barretos
Brazil	Research Site	Brasilia
Brazil	Research Site	Niterói
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Santa Maria
Brazil	Research Site	Santo Andre
Brazil	Research Site	São Paulo
Brazil	Research Site	Vitória
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Changchun
China	Research Site	Changsha
China	Research Site	Chengdu
China	Research Site	Fuzhou
China	Research Site	Fuzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Haikou
China	Research Site	Hangzhou
China	Research Site	Harbin
China	Research Site	Hefei
China	Research Site	Lanzhou
China	Research Site	Lishui
China	Research Site	Nanchang
China	Research Site	Nanjing
China	Research Site	Nantong
China	Research Site	Neijiang
China	Research Site	Shanghai
China	Research Site	Suzhou
China	Research Site	Tianjin
China	Research Site	Urumqi
China	Research Site	Wenzhou
China	Research Site	Wuhan
China	Research Site	Wuhan
China	Research Site	Wuhan
China	Research Site	Xi'an
China	Research Site	Zhengzhou
China	Research Site	Zhengzhou
China	Research Site	Zhuhai
Egypt	Research Site	Alexandria
Egypt	Research Site	Cairo
Egypt	Research Site	Luxor
Egypt	Research Site	Mansoura
Egypt	Research Site	New Cairo
Egypt	Research Site	Shebeen El Kom
France	Research Site	Angers
France	Research Site	Clichy
France	Research Site	Creteil
France	Research Site	MONTPELLIER Cedex 5
France	Research Site	Nantes cedex 1
France	Research Site	Nice
France	Research Site	Paris
France	Research Site	Rennes
France	Research Site	Strasbourg
France	Research Site	Toulouse
France	Research Site	Vandoeuvre Les Nancy
Germany	Research Site	Bonn
Germany	Research Site	Chemnitz
Germany	Research Site	Dresden
Germany	Research Site	Düsseldorf
Germany	Research Site	Frankfurt
Germany	Research Site	Göttingen
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Heidelberg
Germany	Research Site	Kiel
Germany	Research Site	Leipzig
Germany	Research Site	Magdeburg
Germany	Research Site	Ulm
India	Research Site	Ahmedabad
India	Research Site	Ahmedabad
India	Research Site	Ahmedabad
India	Research Site	Bangalore
India	Research Site	Bangalore
India	Research Site	Delhi
India	Research Site	Gurgaon
India	Research Site	Gurugram
India	Research Site	Hyderabad
India	Research Site	JAipur
India	Research Site	Kolkata
India	Research Site	Ludhiana
India	Research Site	Mumbai
India	Research Site	Nagpur
India	Research Site	New Delhi
India	Research Site	New Delhi
India	Research Site	Rishikesh
Italy	Research Site	Arezzo
Italy	Research Site	Firenze
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Roma
Italy	Research Site	Rozzano
Italy	Research Site	Tricase
Japan	Research Site	Chuo-ku
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Hiroshima-shi
Japan	Research Site	Kashihara-shi
Japan	Research Site	Kashiwa
Japan	Research Site	Kumamoto-shi
Japan	Research Site	Mitaka-shi
Japan	Research Site	Morioka-shi
Japan	Research Site	Musashino-shi
Japan	Research Site	Okayama-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osakasayama-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Sunto-gun
Japan	Research Site	Tokushima-shi
Japan	Research Site	Tsu-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Goyang-si
Korea, Republic of	Research Site	Jung-gu
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Malaysia	Research Site	George Town
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Kuching
Malaysia	Research Site	Puncak Alam
Malaysia	Research Site	Selangor
Mexico	Research Site	Guadalajara, Jalisco
Mexico	Research Site	México
Mexico	Research Site	San Luis Potosí
Mexico	Research Site	Tuxtla Gutierrez
Philippines	Research Site	Davao City
Philippines	Research Site	Makati
Philippines	Research Site	Manila
Philippines	Research Site	Pasig City
Philippines	Research Site	Quezon City
Portugal	Research Site	Lisboa
Portugal	Research Site	Vila Real
Puerto Rico	Research Site	Hato Rey Central
Puerto Rico	Research Site	San Juan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Saudi Arabia	Research Site	Ar Riya?
Saudi Arabia	Research Site	Dammam
Saudi Arabia	Research Site	Jeddah
Saudi Arabia	Research Site	Riyadh
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Cordoba
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	San Sebastian
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan City
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Chiang Mai
Thailand	Research Site	Hat Yai
Thailand	Research Site	Khon Kaen
Thailand	Research Site	Phisanulok
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Commack	New York
United States	Research Site	Dallas	Texas
United States	Research Site	Glendale	California
United States	Research Site	Houston	Texas
United States	Research Site	Memphis	Tennessee
United States	Research Site	Mobile	Alabama
United States	Research Site	New York	New York
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Portland	Oregon
United States	Research Site	Santa Fe	New Mexico
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Weston	Florida
United States	Research Site	Yuma	Arizona
Vietnam	Research Site	Ha Noi
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Hcmc
Vietnam	Research Site	Hcmc
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Belgium,  Brazil,  Canada,  China,  Egypt,  France,  Germany,  India,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Philippines,  Portugal,  Puerto Rico,  Russian Federation,  Saudi Arabia,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) for Arm A vs Arm C	PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause	Approximately 5 years
Secondary	Overall Survival (OS) for Arm A vs Arm C	OS is defined as the time from the date of randomization until death due to any cause	Approximately 5 years
Secondary	Progression Free Survival (PFS) for Arm B vs Arm C	PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause	Approximately 5 years
Secondary	Overall Survival (OS) for Arm B vs Arm C	OS is defined as the time from the date of randomization until death due to any cause	Approximately 5 years