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MedImmune HCC D4190C00022 for Liver Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn whether the study drugs Durvalumab and Tremelimumab are safe for patients, and whether the study drug regimen can reduce or slow the growth of your cancer.

Additionally, we want to learn what effects, good or bad, the study drugs may have on your body.

What is the Condition Being Studied?

Hepatocellular carcinoma

Who Can Participate in the Study?

Adults who:
- Have never had treatment with drugs similar to durvalumab, tremelimumab, or bevacizumab
- Have a body weight of at least 66 pounds
- Have hepatocellular carcinoma

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomly assigned (like drawing numbers out of a hat) to one of following 3 study regimens by random chance:
-- Durvalumab given alone at a dose of 1500 mg every 4 weeks.
-- Tremelimumab given alone at a dose of 750 mg every 4 weeks 7 times then every 12 weeks
-- A combination of durvalumab at a dose of 1500 mg and tremelimumab at a dose of 300 mg together 1 time followed by durvalumab alone at a dose of 1500 mg given every 4 weeks

Study Details

Full Title
A Study of Safety, Tolerability, and Clinical Activity of Durvalumab and Tremelimumab Administered as Monotherapy, or Durvalumab in Combination with Tremelimumab or Bevacizumab in Subjects with Advanced Hepatocellular Carcinoma
Principal Investigator
Protocol Number
IRB:PRO00066636
NCT:NCT02519348
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698