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New treatment option for Cholangiocarcinoma
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)
ClinicalTrials.gov ID: NCT06441747
What this study is testing
What is Durvalumab?
Durvalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cholangiocarcinoma.
Also referred to as Imfinzi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Known symptomatic or progressive CNS metastases or leptomeningeal disease. Patients with treated brain metastases are eligible for inclusion in the...
- Patients with severe chronic or active infections requiring systemic antibiotics or antifungals in the two weeks prior to starting trial treatment.
- Any of the following cardiovascular risk factors:
- Acute myocardial infarction (MI) ≤6 months prior to study registration
See the full eligibility criteria
Who can join
- 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)
- Neutrophils ≥ 1.0 x 109/L (without the use of G-CSF in the 4 weeks prior to first dose)
- ALT/AST \<3x ULN irrespective of presence of liver metastases
- Serum bilirubin ≤ 1.5x ULN except in cases of known Gilbert's Syndrome where total bilirubin must be \<4x ULN
- Albumin ≥ 25 g/L
- Serum Creatinine ≤1.5 x ULN or eGFR ≥ 30mL/min/1.73m2 as calculated by Cockcroft Gault Equation
- Able to swallow oral medications without any difficulties or medical history associated with malabsorption or any conditions that may impact on compliance or absorption of the study treatment.
- Women of Childbearing potential must be either totally abstinent or agree to use at least one highly effective method of birth control (e.g., oral contraceptive pill, barrier method) for the duration of the study and...
- Non-sterile males and their female partners must also either be totally abstinent or agree to use at least one highly effective method of birth control (e.g., oral contraceptive pill, barrier method) for the duration of...
- Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations including follow up.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally...
What rules you out
- 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. i...
- 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...
- Patients with severe chronic or active infections requiring systemic antibiotics or antifungals in the two weeks prior to starting trial treatment.
- Any of the following cardiovascular risk factors:
- Acute myocardial infarction (MI) ≤6 months prior to study registration
- New York Heart Association (NYHA) Heart Failure Class III-IV within ≤6 months of registration
- History of cerebral vascular accident (CVA) within 6 months of first dose
- Concurrent enrolment in another clinical study, unless it is an observational (non-treatment) clinical study, or during the follow-up period of an treatment study.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus...
- Patients with vitiligo or alopecia.
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
- Any chronic skin condition that does not require systemic therapy.
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
- Patients with celiac disease controlled by diet alone.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
- History of active primary immunodeficiency.
- Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV...
- Participants co-infected with HBV and HCV, or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and/or anti HBcAb with detectable HBV DNA); AND
- HCV positive (presence of anti-HCV antibodies); OR
- HDV positive (presence of anti-HDV antibodies).
- Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and...
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)
- Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisolone or its equivalent.
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90days after the last dose of IP.19. Female...
The study team makes the final eligibility decision.
Where it's taking place
- Camperdown, New South Wales, Australia
- Clayton, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Westmead, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Bedford Park, South Australia, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camperdown, New South Wales, Australia; Clayton, New South Wales, Australia; St Leonards, New South Wales, Australia; Westmead, New South Wales, Australia; Wollongong, New South Wales, Australia; Woolloongabba, Queensland, Australia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.