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

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Transarterial Chemoembolization (TACE); Drug: Lenvatinib; Drug: Durvalumab; Drug: Tremelimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05301842

D910VC00001

2021-003822-54 (EudraCT Number)

Details and patient eligibility

About

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

Full 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).

Enrollment: 725 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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725 participants in 3 patient groups

Arm A

Experimental group

Description:

Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)

Treatment:

Drug: Tremelimumab

Drug: Lenvatinib

Drug: Durvalumab

Procedure: Transarterial Chemoembolization (TACE)

Arm B

Experimental group

Description:

Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)

Treatment:

Drug: Tremelimumab

Drug: Durvalumab

Procedure: Transarterial Chemoembolization (TACE)

Arm C

Active Comparator group

Description:

Transarterial Chemoembolization (TACE)

Treatment:

Procedure: Transarterial Chemoembolization (TACE)