Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment (EMERALD-2)

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Durvalumab; Drug: Bevacizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03847428

2018-004105-85 (EudraCT Number)

D910DC00001

2023-507689-26-00 (Registry Identifier)

Details and patient eligibility

About

A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

Full description

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation.

Enrollment: 908 patients

Sex: All

Ages: 18 to 150 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
• Imaging to confirm disease-free status within 28 days prior to randomization
• ECOG 0-1 at enrolment
• Child-Pugh score of 5 or 6
• Adequate organ and marrow function.

Exclusion criteria

• Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
• Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
• History of hepatic encephalopathy within 12 months prior to randomization
• Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
• Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
• Active co-infection with HBV and HDV.
• Receipt of prior systemic anticancer therapy for HCC
• Those on a waiting list for liver transplantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

908 participants in 3 patient groups, including a placebo group

Arm A

Experimental group

Description:

Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)

Treatment:

Drug: Bevacizumab

Drug: Durvalumab

Arm B

Experimental group

Description:

Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)

Treatment:

Other: Placebo

Drug: Durvalumab

Arm C

Placebo Comparator group

Description:

Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)

Treatment:

Other: Placebo