BIL-PPP

Protocol Title

Phase II study of the combination of durvalumab (MEDI4736) (PDL1 inhibitor) and olaparib (PARP inhibitor) in advanced cholangiocarcinoma after initial chemotherapy and durvalumab (BIL-PPP)

Purpose of the Study

Cholangiocarcinomas are a rare and aggressive form of cancer that forms in the bile ducts. They are typically diagnosed in advanced stages and associated with poor prognosis. Globally, cholangiocarcinoma accounts for 10-20% of all deaths attributable to cancers in the hepatobiliary system (liver, gallbladder, and bile duct).  In the first line setting, for over a decade doublet chemotherapy of cisplatin-gemcitabine has been considered the standard of care. Adding durvalumab to first-line treatment and maintenance treatment has shown improvement in both progression-free survival and overall survival. The addition of durvalumab in the maintenance setting in metastatic or locally advanced cholangiocarcinoma is now largely considered standard of care.

The combination of durvalumab and olaparib has been observed to improve overall survival in patients with ovarian cancer. This study aims to investigate whether the combination of durvalumab and olaparib in the maintenance setting after initial chemotherapy and durvalumab will benefit patients with locally advanced or metastatic cholangiocarcinoma.

Contact email

bil.ppp@onjcri.org.au

Study Chairs

Professor Niall Tebbutt
Dr Laura Tam

Detailed information available

More detailed information available online at ClinicalTrials.gov please click here.

funding

Supported by a grant from the Wayne Elphinstone Research Fund, AstraZeneca and GI Cancer Trials (formerly AGITG).

Patients Recruited

Click here to access the table and view recruitment data on all open trials:

Open Trial Recruitment Table