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.
Single group
Durvalumab
DrugDurvalumab will be administered at a dose of 1500mg intravenously every 4 weeks.
Olaparib
DrugOlaparib is administered at a dose of 300mg bd in a continuous 28-day cycle. On day 1 of each cycle, the morning dose of Olaparib should be taken no more than 1 hour prior to infusion of durvalumab. It is expected that patients will receive up to 24 months of a combination of olaparib and durvalumab, or until disease progression, unacceptable toxicities, or withdrawal of consent.
Primary Objective
To describe the efficacy of PARPi and PDL1 inhibition in the maintenance setting of metastatic cholangiocarcinomas.
Evaluate benefit
To refine selection of the patient population who are most likely to benefit from the combination of PDL1 (durvalumab) and PARP (olaparib) inhibition in the maintenance setting following initial chemotherapy (cisplatin + gemcitabine + durvalumab) (post hoc translational analysis).
Evaluate toxicity
To evaluate toxicity of the combination of durvalumab and olaparib.
Progression free survival
To evaluate progression-free survival with the combination of durvalumab and olaparib (PFS).
Overall survival
To evaluate overall survival with the combination of durvalumab and olaparib (OS).
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Australasian Gastro-Intestinal Trials Group
Lead sponsor
Wayne Elphinstone Research Fund
Collaborator
AstraZeneca
Collaborator
