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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT06650709
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are able to give written consent and are willing to follow the study procedures as outlined in the consent form.
- People who have been diagnosed with high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by tissue testing.
- People who have not yet received chemotherapy for this cancer.
- People with Stage IVA or IVB disease who are not suitable for upfront surgery but who are expected to proceed to surgery if the cancer responds to treatment.
- People who either have cancer tissue available for biopsy before surgery, or have enough stored tissue samples available for additional research testing, including genetic pathway testing.
- People who have at least one area of cancer that can be measured by CT scan (or MRI if CT is not suitable) taken within 28 days before the first treatment dose.
- People aged 18 years or older.
- People who weigh more than 30 kg.
- People who are assessed as reasonably active and able to carry out daily activities (rated 0 or 1 on a standard scale), assessed within 7 days of joining the study.
- People with a life expectancy of more than 4 months.
- People whose blood, liver, and kidney function results are within acceptable ranges, tested within 14 days before the first dose, including: platelet count of at least 100×10⁹/L; haemoglobin of at least 10 g/dL without a blood transfusion in the past 28 days; neutrophil count of at least 1.5×10⁹/L; total bilirubin no more than 1.5 times the upper limit of normal (unless due to a condition called Gilbert's syndrome); liver enzyme levels (AST and ALT) no more than 2.5 times the upper limit of normal, or up to 5 times if liver metastases are present; and kidney function showing an estimated clearance rate of at least 51 mL/min.
- Women who could become pregnant and are sexually active with a male partner who has not been sterilised must agree to use at least one acceptable form of contraception from the time of signing consent, throughout treatment, and for at least 6 months after the last dose of olaparib or bevacizumab, and at least 90 days after the last dose of durvalumab — or must completely abstain from sexual activity during these periods.
- Male partners of women in the trial who have not been sterilised must use a condom plus spermicide throughout the relevant period.
- Contraception decisions after the required period should be discussed with a doctor; complete abstinence is acceptable, but periodic abstinence, the rhythm method, and the withdrawal method are not accepted as sufficient.
- Women must either be postmenopausal or have a negative pregnancy test (urine or blood) within 28 days before treatment and confirmed again on the first day of treatment. Postmenopausal is defined as: no periods for 1 or more years after stopping hormone treatments; hormone levels (LH and FSH) in the postmenopausal range for women under 50; ovaries removed by radiation with last period more than 1 year ago; menopause caused by chemotherapy with more than 1 year since last period; or surgical removal of both ovaries or the uterus.
- People who are willing and able to attend scheduled visits, follow treatment plans, undergo biopsies during the study, and complete required tests and procedures.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who are already known to carry a BRCA1 or BRCA2 gene mutation (inherited or in the tumour) before the screening process begins.
- People who have had an allergic reaction to any medicine that is chemically similar to olaparib, durvalumab, or bevacizumab.
- People who have received any other anti-cancer treatment — including chemotherapy, immunotherapy, hormonal therapy, or experimental treatments — within 4 weeks before joining the study.
- People who have taken part in another clinical trial using an experimental medicine within 4 weeks before joining.
- People who have previously been treated with an immune checkpoint inhibitor, including durvalumab, regardless of which treatment arm they were assigned to.
- People who are currently enrolled in another clinical trial involving an active treatment (observational studies or follow-up periods from a previous interventional trial are exceptions).
- People who have previously received a PARP inhibitor, VEGF-targeted therapy, or PD-1/PD-L1/CTLA-4 targeted therapy for this cancer or any other cancer in the last 5 years.
- People who previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy and experienced a side effect that permanently stopped that treatment, or who had a severe immune-related side effect (grade 3 or higher, or any grade affecting the nervous system or eyes), or whose side effects have not fully resolved, or who needed immunosuppressant medicines (beyond corticosteroids) to manage side effects, or who currently require more than 10 mg per day of prednisone or equivalent.
- People who have had another cancer in the last 5 years, except for certain treated and resolved cancers such as non-melanoma skin cancer, cervical cancer in situ, ductal breast carcinoma in situ, early-stage low-grade endometrial cancer, or other solid tumours that were treated with curative intent and have shown no evidence of disease for 5 or more years.
- People who are considered medically high risk due to serious uncontrolled medical conditions, such as uncontrolled irregular heartbeat, a heart attack within the last 3 months, uncontrolled seizures, unstable spinal cord compression, superior vena cava syndrome, extensive lung disease on imaging, or a psychiatric condition that prevents giving informed consent.
- People who are unable to swallow tablets or capsules, or who have digestive conditions likely to affect how the study medicines are absorbed.
- People with heart rhythm abnormalities or other uncontrolled heart conditions identified on a resting ECG, or with a condition called congenital long QT syndrome.
- People with a corrected heart interval measurement (QTcF) of 470 ms or more, averaged across 3 ECG readings taken 5 minutes apart.
- People with unresolved side effects (grade 2 or higher) from previous cancer treatment, except for hair loss, skin pigment changes (vitiligo), or blood results already covered in the inclusion criteria; nerve-related side effects of grade 2 or higher will be reviewed individually; people with permanent side effects not expected to worsen with study treatment may be considered after discussion with the study sponsor.
- People with a blood or bone marrow disorder called myelodysplastic syndrome or acute myeloid leukaemia, or signs suggesting these conditions.
- People who have had major surgery within 2 weeks before starting treatment, or who have not yet fully recovered from a recent major surgery.
- People who have previously had an allogeneic bone marrow transplant or double umbilical cord blood transplantation.
- People with uncontrolled ongoing illness including active infections, uncontrolled high blood pressure, unstable chest pain, heart rhythm problems, lung inflammation, serious ongoing bowel conditions causing diarrhoea, or mental health or social circumstances that would make it difficult to follow study requirements or that would significantly increase health risks.
- People with a history of cancer spread to the lining of the brain and spinal cord (leptomeningeal carcinomatosis).
- People for whom bevacizumab is not medically appropriate, including those at risk of bowel perforation, with uncontrolled bleeding or clotting disorders, or with signs or symptoms of bowel obstruction currently or within 28 days before enrolment.
- People currently taking certain medicines that strongly or moderately affect how the body processes olaparib (specific CYP3A inhibitors or inducers), unless a sufficient washout period has passed (2 weeks for inhibitors; 5 weeks for enzalutamide or phenobarbital; 3 weeks for other inducers) (confirm with trial site).
- People with brain metastases causing symptoms that are not controlled; people with spinal cord compression unless they have had definitive treatment and have been clinically stable for 28 days (a brain scan is not required to confirm absence of brain metastases; stable corticosteroid use started at least 4 weeks before treatment is permitted).
- People with active primary immunodeficiency; people who are HIV-positive must have an undetectable viral load to be considered; people with active tuberculosis are not eligible.
- People with known active hepatitis B or C infection; people with past resolved hepatitis B may be eligible; people with hepatitis C antibodies may be eligible only if a specific RNA test is negative (confirm with trial site).
- Women who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception from screening until 90 days after the last dose of durvalumab.
- People who have received a live attenuated vaccine within 30 days before enrolment.
- People with active or previously documented autoimmune or inflammatory conditions — such as inflammatory bowel disease, lupus, sarcoidosis, rheumatoid arthritis, and others — within the past 3 years, with exceptions including: people with vitiligo or hair loss; people with a stable thyroid condition managed with hormone replacement; people with a chronic skin condition not requiring systemic treatment; people whose condition has been inactive for 5 or more years (only after consultation with the study sponsor); and people with coeliac disease managed by diet alone.
- People who have used immunosuppressive medicines within 14 days before the first dose, with exceptions for: nasal, inhaled, topical, or local steroid injections; low-dose systemic steroids at no more than 10 mg/day of prednisone or equivalent; and steroids used as pre-medication for allergic reactions (such as before a CT scan).
- People with any other serious medical, psychiatric, or laboratory condition that the treating doctor believes would make participation unsafe or affect the reliability of study results.
- People whom the treating doctor considers unsuitable for the study or unlikely to be able to follow study requirements.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
British Columbia Cancer Agency
Registry
ClinicalTrials.gov
Start date
1 November 2024
Est. completion
1 May 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
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.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.