A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (EMERALD-2)

Purpose

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. 888 patients will be enrolled globally.

Criteria

Confirmed HCC and successfully completed curative therapy (resection or ablation).

Underwent a hepatic resection

Ablation (radiofrequency or microwave, cryoablation, or PEI per institutional standard)

You Cannot :

Have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism

Have a history of significant bleeding disorders, vasculitis, or a significant bleeding from the GI tract w/in 3 months ·

Have a history of GI perforation and/or fistulae within 6 months prior to randomization.

Have uncontrolled hypertension ·

Evidence of portal vein thrombosis

Clinically meaningful ascites

Receipt of prior systemic anticancer therapy for HCC. ·         History of allogeneic organ transplantation or those who are on a waiting list for liver transplantation.

Details

This study will enroll patients with Hepatic Cellular Cancer who are at high risk of recurrence after curative hepatic resection or ablation.

Arm A: Durvalumab + bevacizumab 15 mg/kg (every 3 weeks) Arm B: Durvalumab + bevacizumab placebo (every 3 weeks) Arm C: Durvalumab placebo + bevacizumab placebo (every 3 weeks)

Interested in more information on clinical research? Contact WK Physician Network Clinical Research at 318-212-8613



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Hematology Oncology Associates

IRB: WIRB
IRB Number:
Trial Type: Drug
Sponsor: Astra Zenca