Durvalumab alone or in combination with bevacizumab for HCC after curative resection or ablation - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drug durvalumab, either alone or with bevacizumab, can be used to prevent the return of hepatocellular carcinoma.

What is the Condition Being Studied?

Hepatocellular Carcinoma

Who Can Participate in the Study?

Adults with hepatocellular carcinoma who:
-Had their hepatocellular carcinoma recently treated with surgery or ablation; and
-Are considered to be at a high risk of recurrence.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Be randomly assigned (like drawing names from a hat) to 1 of 3 groups:
---Group A will get the study drugs durvalumab and bevacizumab
---Group B will get durvalumab and a placebo (harmless saline)
---Group C will get placebos instead of both drugs

Both Groups will:
-Get their treatment through an I.V. once every 3 weeks for 1 year.
-Give blood and urine samples during their clinic visits
-Have regular CT or MRI scans done to see if their cancer has returned

Study Details

Full Title
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)
Principal Investigator
Protocol Number
IRB: PRO00102932
NCT: NCT03847428
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698