NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study (NCT06650709) | Clinical Trial Compass
Not Yet RecruitingPhase 2
NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study
40 participantsStarted 2024-11-01
Plain-language summary
The goal of this phase 2 clinical trial is to learn if the three treatments olaparib, durvalumab and bevacizumab can treat participants with a diagnosis of stage 4 high grade serous ovarian cancer that is too advanced to undergo upfront surgery.
The main questions it aims to answer are:
Is the treatment able to shrink the cancer sufficiently for participants to undergo surgery? Is the combination of treatments safe in this neoadjuvant (before surgery) setting? This is a single arm study with no comparator arm.
Participants will receive the treatment up to 3 cycles with each drug given as follows in a 28-day cycle:
Olaparib orally on a twice daily continuous dosing schedule Durvalumab given intravenously on day 1 Bevacizumab given intravenously on day 1 and 15 (Day 15 omitted in C3)
Participants will be assessed throughout the study for safety and efficacy endpoints
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
. Histologically proven high grade serous ovarian/ fallopian tube or primary peritoneal cancer.
. Chemotherapy naïve for high grade serous ovarian/ fallopian tube or primary peritoneal cancer.
. FIGO Stage IVA/B disease not suitable for primary debulking surgery but must have the intention of proceeding to interval surgical debulking if treatment response is demonstrated
. Patients must have disease amenable to pre-operative screening biopsies for additional translational endpoints or availability of sufficient archival tissue for additional translational endpoints including HRR pathway testing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the efficacy of the triplet combination Olaparib-Durvalumab-Bevacizumab in the neoadjuvant setting in subjects with FIGO Stage IV high grade serous ovarian cancer.
Timeframe: Approximately 3 years, including 1 year of recruitment, 6 months treatment period, and 1 year of follow-up
. At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (or magnetic resonance imaging \[MRI\] where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.1. The baseline scan must be obtained within 28 days prior to the first dose of study treatment.
. Age ≥18 years.
. Body weight \>30 kg
Exclusion criteria
. Known germline BRCA1/2 mutation carriers or known somatic BRCA1/2 mutation associated HGSOC (prior to screening)
. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the Triplet Combination (olaparib, durvalumab, bevacizumab).
. Use of any other anti-cancer therapy including systemic, targeted, immunotherapy, hormonal, biological, chemotherapy, other novel agents or investigational agents within 4 weeks of registration.
. Participation in another clinical trial with an investigational product within 4 weeks of registration
. Previous treatment with an immune checkpoint inhibitor, including durvalumab study regardless of treatment arm assignment
. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
. Previously received a PARP/VEGF/PD/L-1/CTLA4 targeted therapy for this cancer diagnosis or any other cancer diagnosis in the last 5 years.
. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4: