Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP In… (NCT06441747) | Clinical Trial Compass
RecruitingPhase 2
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)
Australia40 participantsStarted 2024-09-23
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years, and life expectancy\>12 weeks
✓. Weight: \>30kg
✓. Histologically proven locally advanced or metastatic/unresectable cholangiocarcinoma
✓. Documentation of RECISTv1.1 measurable disease
✓. Must not have had radiologic progression after 6-8 cycles of gemcitabine and cisplatin and durvalumab
✓. Adequate haematological and end-organ function as defined by the following parameters:
✓. Haemoglobin ≥ 90g/L (without a transfusion in the past two weeks)
✓. Platelets ≥100 x 109/L (without a transfusion in the past two weeks)
Exclusion criteria
✕. 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.
What they're measuring
1
Primary Objective
Timeframe: 12 months post randomisation
2
Evaluate benefit
Timeframe: 12 months post randomisation
Trial details
NCT IDNCT06441747
SponsorAustralasian Gastro-Intestinal Trials Group