Phase 1 Ovarian Cancer Trial, Not Yet Recruiting
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
- Women aged between 18 and 75 years (inclusive) at the time of signing the consent form.
- People who have been diagnosed with epithelial ovarian cancer (a specific type of ovarian cancer confirmed by laboratory testing of tissue), at Stage II or Stage III according to an internationally recognised staging system (FIGO 2014).
- People who have had cytoreductive surgery (an operation to remove as much of the tumour as possible), where laboratory testing of the removed tissue confirmed a very small amount of microscopic tumour remaining at the surgical edge (1 mm or less).
- People for whom suitable tumour tissue collected during surgery is available for specialised genetic screening — either a fresh tissue sample of at least 100 mg, or at least 5 preserved tissue slices meeting specific quality requirements (confirm with trial site).
- People whose tumour tissue, when tested using advanced genetic analysis, shows at least 5 usable targets called "neoantigens" that meet specific technical thresholds (confirm with trial site).
- People whose post-surgery scan (contrast-enhanced pelvic MRI or CT) shows no visible remaining tumour, and no signs of cancer spread to the lungs, liver, or bones.
- People who are generally well enough to carry out light daily activities, with a performance score of 0 or 1 on a standard medical scale, and who are expected to live for at least one year.
- People whose blood tests taken within 14 days before joining the trial show that the heart, liver, kidneys, thyroid, and blood-clotting system are all functioning within acceptable ranges — without needing blood transfusions, growth factor injections, or albumin during that period (confirm specific values with trial site).
- Women who could potentially become pregnant must have a negative pregnancy blood test before joining, and must agree to use effective contraception (such as condoms or an intrauterine device) from the first dose until 6 months after the last dose.
- People who are willing and able to follow the trial schedule and attend all required follow-up visits, with the support of their family members.
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 whose ovarian cancer has been confirmed by laboratory testing to be a non-epithelial type, such as germ cell tumours (e.g., teratoma, yolk sac tumour), sex cord-stromal tumours (e.g., granulosa cell tumour), or cancer that has spread to the ovary from another part of the body (e.g., from the gastrointestinal tract).
- People who had visible tumour remaining after surgery (known as R2 resection), or whose post-surgery scans show cancer has spread to distant parts of the body such as the lungs, liver, or brain, or who have Stage IV disease.
- People who have previously received any cancer vaccine (such as a peptide, DNA, or mRNA vaccine for cancer), or who have used certain immune-boosting drugs called checkpoint inhibitors (e.g., anti-PD-1/PD-L1 or anti-CTLA-4 antibodies) within 30 days before joining the trial.
- People who have had serious complications from surgery within the 4 weeks after the operation, including severe abdominal infection requiring intravenous antibiotics for 7 or more days, a bowel leak needing surgical repair, major bleeding requiring a large blood transfusion, or a severe bowel blockage requiring tube decompression for 3 or more days.
- People who have an active autoimmune disease (where the immune system attacks the body), or a history of one that currently requires long-term immune-suppressing medication for 2 weeks or more — including conditions such as rheumatoid arthritis, lupus, ulcerative colitis with a flare-up in the past year, multiple sclerosis with a relapse in the past 2 years, or autoimmune thyroid disease requiring high doses of thyroid hormone.
- People who have had an active infection in the month before joining, including serious bacterial infections (such as pneumonia or kidney infection), certain viral infections (such as active hepatitis B with a high viral load, untreated hepatitis C, HIV, or active chickenpox or cytomegalovirus with fever or organ involvement), or certain fungal infections confirmed by imaging and laboratory testing.
- People with serious heart, lung, liver, or kidney problems, including a heart attack or unstable chest pain in the past 6 months, heart failure, poorly controlled high blood pressure despite medication, severe lung disease, active tuberculosis, liver cirrhosis, active hepatitis, gastrointestinal bleeding in the past year, or kidney failure requiring dialysis or significant loss of protein through the urine.
- People with poorly controlled diabetes (high blood sugar despite medication), or thyroid problems where hormone levels remain outside the normal range despite treatment.
- People who have a known allergy or severe reaction to any component of the trial treatments, including the ingredients in the mRNA vaccine (such as lipid nanoparticles or the adjuvant poly-ICLC) or anti-PD-1 antibodies — or who have previously had a severe allergic reaction (such as anaphylactic shock, throat swelling, or severe breathing difficulty) to similar treatments such as COVID-19 mRNA vaccines or other monoclonal antibody therapies.
- People who have used immune-suppressing medications within 2 weeks before joining the trial (such as corticosteroids at certain doses, cyclosporine, tacrolimus, methotrexate, or azathioprine), or who plan to use such medications during the trial.
- People who have been diagnosed with another cancer in the past 5 years, except for certain fully treated skin cancers, cervical carcinoma in situ, or early-stage breast cancer in the milk ducts — all of which must have been treated with curative surgery and shown no signs of return.
- People who are pregnant (positive pregnancy blood test) or currently breastfeeding, or women who could become pregnant but are unwilling to use effective contraception throughout the required period.
- People with psychiatric conditions (such as dementia, severe depression, or schizophrenia) or cognitive difficulties that would prevent them from understanding or following the trial procedures.
- People who have taken part in another interventional clinical trial (receiving an experimental drug, device, or other study treatment) within the 30 days before joining, or who are still completing the follow-up requirements of another trial.
- People who are unable or unwilling to sign a written consent form or to follow the requirements of the trial.
- People who the trial doctor considers unsuitable for any other reason.
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.
GP referral letter
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Trial details
Primary endpoints
Incidence of Treatment-Emergent Adverse Events Assessed by CTCAE Version 5.0
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.