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

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Transarterial Chemoembolization (TACE); Drug: Bevacizumab; Drug: Durvalumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03778957

2023-509053-32-00 (Registry Identifier)

2018-002134-20 (EudraCT Number)

D933GC00001

Details and patient eligibility

About

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

Full 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

Enrollment: 724 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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724 participants in 3 patient groups, including a placebo group

Arm A

Experimental group

Description:

Transarterial Chemoembolization (TACE) in combination with Durvalumab

Treatment:

Other: Placebo

Drug: Durvalumab

Procedure: Transarterial Chemoembolization (TACE)

Arm B

Experimental group

Description:

Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab

Treatment:

Drug: Durvalumab

Procedure: Transarterial Chemoembolization (TACE)

Drug: Bevacizumab

Arm C

Placebo Comparator group

Description:

Transarterial Chemoembolization (TACE) in combination with Placebos

Treatment:

Other: Placebo

Procedure: Transarterial Chemoembolization (TACE)