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HALOZYME HALO -110-101 for Liver and Biliary Cancers - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the two study drugs PEGPH20 and Atezolizumab given with the current standard of care medications Cisplatin and Gemcitabine are safe and to find out what dose will work in patients with liver or biliary cancers.

What is the Condition Being Studied?

Liver and biliary cancers

Who Can Participate in the Study?

Adults who:
-Have previously untreated, locally advanced or metastatic ICC, ECC, and gallbladder adenocarcinoma

Age Group
Adults

What is Involved?

you choose to join this study, you will:
-Be randomized (like drawing numbers out of a hat) to get either:
-- The combination of PEGPH20, cisplatin and gemcitabine
-- PEGPH20, atezolizumab, cisplatin and gemcitabine,
-- The standard of care for your cancer, which is cisplatin and gemcitabine
- Have tests, exams, and procedures that are part of your standard care and for study purposes.
-- Each clinic visit will last 4-5 hours

Study Details

Full Title
A Phase 1b, Randomized, Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Cisplatin Plus Gemcitabine and PEGPH20 in Combination With Atezolizumab and Cisplatin Plus Gemcitabine Compared With Cisplatin Plus Gemcitabine in Subjects with Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Principal Investigator
Protocol Number
IRB:PRO00089907
NCT:NCT03267940
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698