The aim of this study is 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.
Age ≥18 years, and life expectancy>12 weeks
Weight: >30kg
Histologically proven locally advanced or metastatic/unresectable cholangiocarcinoma
Documentation of RECISTv1.1 measurable disease
Previous use of a PARP inhibitor.
All prior treatment-related AEs must have resolved to a CTCAE v5 Grade 1 or less prior to commencement of study medication, with the exception of alopecia and peripheral neuropathy which can be grade 2 or less.
Known symptomatic or progressive CNS metastases or leptomeningeal disease. Patients with treated brain metastases are eligible for inclusion in the study if they had received treatment >4 weeks prior to commencement of study medication, and have a repeat MRI scan demonstrating stability in disease.
Patients with severe chronic or active infections requiring systemic antibiotics or antifungals in the two weeks prior to starting trial treatment.
Australasian Gastro-Intestinal Trials Group
Lead sponsor
Wayne Elphinstone Research Fund
Collaborator
AstraZeneca
Collaborator