Study identifier:D910DC00001
ClinicalTrials.gov identifier:NCT03847428
EudraCT identifier:2018-004105-85
CTIS identifier:2023-507689-26-00
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
Hepatocellular Carcinoma
Phase 3
No
Durvalumab, Bevacizumab
All
908
Interventional
18 Years - 150 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm A Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W) | Drug: Durvalumab Durvalumab IV (intravenous) Other Name: IMFINZI Drug: Bevacizumab Bevacizumab IV (intravenous) Other Name: AVASTIN |
Experimental: Arm B Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W) | Drug: Durvalumab Durvalumab IV (intravenous) Other Name: IMFINZI Other: Placebo Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking |
Placebo Comparator: Arm C Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W) | Other: Placebo Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking |