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

Hepatocellular Carcinoma Clinical Trial

— EMERALD-1  

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 (EMERALD-1)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03778957
• Other study ID #: D933GC00001
• Secondary ID: 2018-002134-20
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 30, 2018
• Est. completion date: August 31, 2026

Study information

• Verified date: February 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 724
• Est. completion date: August 31, 2026
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

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)

Locations

Country	Name	City	State
Australia	Research Site	Benowa
Australia	Research Site	Box Hill
Australia	Research Site	Camperdown
Australia	Research Site	Clayton
Australia	Research Site	Herston
Australia	Research Site	Liverpool
Australia	Research Site	Melbourne
Brazil	Research Site	Barretos
Brazil	Research Site	Florianópolis
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Santa Maria
Brazil	Research Site	São José do Rio Preto
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Vitória
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	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	Guangzhou
China	Research Site	Hangzhou
China	Research Site	Harbin
China	Research Site	Hefei
China	Research Site	Nanchang
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Nantong
China	Research Site	Neijiang
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Shenzhen
China	Research Site	Tianjin
China	Research Site	Wuhan
China	Research Site	Wuhan
China	Research Site	Xi'an
China	Research Site	Zhengzhou
China	Research Site	Zhuhai
France	Research Site	Bobigny
France	Research Site	Clichy
France	Research Site	Grenoble cedex 9
France	Research Site	Montpellier CEDEX 5
France	Research Site	Nice Cedex 3
France	Research Site	Paris Cedex 13
France	Research Site	Pessac
France	Research Site	Toulouse Cedex 9
France	Research Site	Vandoeuvre Les Nancy
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	Shatin
India	Research Site	Bangalore
India	Research Site	Bengaluru
India	Research Site	Hyderabad
India	Research Site	Kolkata
India	Research Site	Kolkata
India	Research Site	Madurai
India	Research Site	Mumbai
India	Research Site	Nashik
India	Research Site	Pune
India	Research Site	Surat
India	Research Site	Vijayawada
India	Research Site	Vishakhapatnam
Italy	Research Site	Arezzo
Italy	Research Site	Brescia
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Pisa
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Chiba-shi
Japan	Research Site	Chuo-ku
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Hiroshima-shi
Japan	Research Site	Kurume-shi
Japan	Research Site	Musashino-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Okayama
Japan	Research Site	Osaka-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osakasayama-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Shiwa-gun
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	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Mexico	Research Site	Alc. Cuauhtémoc
Mexico	Research Site	Culiacan
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mérida
Mexico	Research Site	Mexico
Mexico	Research Site	Monterrey
Mexico	Research Site	Monterrey
Mexico	Research Site	Tuxtla Gutierrez
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Obninsk
Russian Federation	Research Site	Sankt-Peterburg
Russian Federation	Research Site	St. Petersburg
Singapore	Research Site	Bukit Merah
Spain	Research Site	Córdoba
Spain	Research Site	Madrid
Spain	Research Site	Pamplona
Spain	Research Site	San Sebastián(Guipuzcoa)
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Liou Ying Township
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 City
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	Aurora	Colorado
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boston	Massachusetts
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Cleveland	Ohio
United States	Research Site	Costa Mesa	California
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Detroit	Michigan
United States	Research Site	Durham	North Carolina
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Knoxville	Tennessee
United States	Research Site	La Jolla	California
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Mobile	Alabama
United States	Research Site	Morgantown	West Virginia
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orange	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Rochester	Minnesota
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Sioux Falls	South Dakota
United States	Research Site	Stony Brook	New York
United States	Research Site	Tucson	Arizona
United States	Research Site	Washington	District of Columbia
United States	Research Site	Westwood	Kansas
United States	Research Site	Winston-Salem	North Carolina
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Australia,  Brazil,  Canada,  China,  France,  Hong Kong,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Russian Federation,  Singapore,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of Durvalumab and Bevacizumab as evaluated by summary of adverse events by treatment arm and CTCAE grade		Approximately 5 years
Other	Immunogenicity of Durvalumab and Bevacizumab as measured by presence of anti-drug antibodies (ADAs)		Approximately 5 years
Other	Pharmacokinetics (PK) of Durvalumab and Bevacizumab as determined by peak serum concentrations		Approximately 5 years
Primary	Progression Free Survival (PFS) for Arm B vs Arm C	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	Approximately 5 years
Secondary	Progression Free Survival (PFS) for Arm A vs Arm C	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	Approximately 5 years
Secondary	Overall Survival (OS)	OS is defined as the time from the date of randomization until death due to any cause	Approximately 5 years
Secondary	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)	Collection of patient reported outcome (PRO) measures to assess time to deterioration in global health status/quality of life (QoL), functioning (physical) and symptoms	Approximately 5 years
Secondary	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)	Collection of patient reported outcome (PRO) measures to assess time to deterioration in symptoms	Approximately 5 years