Actively Recruiting
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)
Led by Australasian Gastro-Intestinal Trials Group · Updated on 2026-05-06
40
Participants Needed
8
Research Sites
201 weeks
Total Duration
On this page
Sponsors
A
Australasian Gastro-Intestinal Trials Group
Lead Sponsor
W
Wayne Elphinstone Research Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with life expectancy greater than 12 weeks
- Weight over 30 kg
- Histologically confirmed locally advanced or metastatic/unresectable cholangiocarcinoma
- Measurable disease according to RECIST v1.1 criteria
- No radiologic progression after 6-8 cycles of gemcitabine, cisplatin, and durvalumab
- Adequate blood counts and organ function as defined by specific laboratory parameters
- Ability to swallow oral medications without issues
- Women of childbearing potential must agree to effective birth control and have a negative pregnancy test before starting treatment
- Non-sterile males and their female partners must agree to effective birth control during and for 6 months after treatment
- Willingness and ability to comply with the study protocol and visits
- Able to provide signed informed consent
You will not qualify if you...
- Previous treatment with a PARP inhibitor
- Any prior treatment-related adverse events above specified severity except alopecia and mild peripheral neuropathy
- Symptomatic or progressive brain metastases or leptomeningeal disease unless stable after treatment
- Severe infections requiring systemic antibiotics or antifungals within 2 weeks prior to treatment
- Recent serious cardiovascular events or conditions within 6 months
- Participation in another interventional clinical trial
- Extensive radiotherapy to bone marrow or recent major surgery within specified timeframes
- History of allogeneic organ transplantation
- Active or prior autoimmune or inflammatory disorders, with some exceptions
- Uncontrolled illnesses or psychiatric/social issues affecting compliance
- History of other primary cancers with some exceptions
- Prolonged QT interval on ECG
- Active primary immunodeficiency
- Active hepatitis or certain viral infections unless controlled
- Known HIV infection that is not well controlled
- Use of immunosuppressive medication shortly before treatment except specific exceptions
- Recent live vaccine administration
- Pregnancy or breastfeeding or unwillingness to use effective birth control
- Allergy or hypersensitivity to study drugs or their ingredients
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
2
Monash Medical Centre
Clayton, New South Wales, Australia, 3168
Actively Recruiting
3
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
4
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
5
Wollongong and Shoalhaven District Memorial Hospital
Wollongong, New South Wales, Australia, 2500
Not Yet Recruiting
6
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
7
Flinders Medical Centre
Bedford Park, South Australia, Australia
Actively Recruiting
8
Austin Health
Melbourne, Victoria, Australia, 3084
Actively Recruiting
Research Team
C
Clinical Project Manager
CONTACT
S
Sandra Bahamad
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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