Printed from Voxsanity (voxsanity.com.au) — NCT07591831 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT07591831
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 between 18 and 75 years of age at the time of signing consent.
- People who have been diagnosed through laboratory testing with a specific type of cancer affecting the ovaries, fallopian tubes, or the lining of the abdomen (peritoneum), at an advanced stage (FIGO stage II–IV).
- People whose cancer came back and stopped responding to platinum-based chemotherapy, meaning the cancer progressed within 6 months after finishing that treatment — but not people whose cancer progressed within 4 weeks of starting platinum chemotherapy for the first time; people may have received up to two prior rounds of non-platinum treatment, with certain maintenance therapies not counted as a treatment round.
- People who are able to provide tumour tissue samples (preserved in a specific way called formalin-fixed paraffin-embedded) for a specific lab test; people who cannot provide tissue slides for certain reasons may still be considered at the trial doctor's discretion.
- People who have at least one tumour that can be measured on scans according to standard criteria (RECIST version 1.1), where that tumour has not previously been treated with radiation — or, if it was in a previously treated area, where the cancer has been confirmed to have grown back.
- People whose general health and ability to carry out daily activities meets a standard medical rating of 0 or 1 (meaning fully active or able to carry out light work).
- People who are expected to live for at least 3 months.
- People whose blood and organ function meet all of the following levels in tests taken within 14 days before the first dose, without recent blood transfusions, blood-boosting injections, or medications to correct blood counts: a type of white blood cell count at or above a certain level; platelet count at or above a certain level; haemoglobin (red blood cell measure) at or above a certain level; kidney function within an acceptable range; liver function measures within acceptable ranges (with slightly higher limits allowed for people with a specific liver condition called Gilbert's syndrome or with liver involvement from cancer); and blood clotting measures within an acceptable range, without use of blood-thinning medications in the 14 days before the first dose, except for people who need long-term blood thinners for an existing condition.
- People whose side effects from previous cancer treatments have largely resolved to a mild or absent level before joining, with the exception of hair loss and tiredness.
- People who understand the study and are willing to sign a written consent form before taking part.
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 with a history of a severe allergic reaction to treatments in the monoclonal antibody class of medicines, or who have uncontrolled allergic asthma.
- People with cancer that has spread to the brain or nervous system that has not been treated, or that has been treated but is still causing symptoms; people with remaining mild signs related to brain treatment may still be considered if those symptoms have been stable or improving for at least 2 weeks before screening.
- People with a known history of a primary immune system deficiency condition.
- People with an active autoimmune disease or a history of autoimmune disease; people with well-controlled type 1 diabetes, well-controlled low thyroid requiring only hormone replacement, certain skin conditions not needing systemic treatment (such as vitiligo, psoriasis, or hair loss), or conditions not expected to return without an external trigger may still be considered for further screening.
- People who have had a serious blood clot or blood vessel event in the 3 months before screening, such as a mini-stroke, brain bleed, stroke, deep vein clot, or a clot in the lungs.
- People with a history of a lung condition called interstitial lung disease, except for a localised type caused by radiation, or a non-infectious type of lung inflammation that required steroid treatment.
- People who have previously received any medicine that works by targeting certain immune system pathways (including treatments targeting PD-1, PD-L1, PD-L2, CTLA-4, OX40, or CD137).
- People who previously had a serious immune-related side effect (rated Grade 3 or higher) from immunotherapy.
- People who have had major surgery or intensive radiotherapy within 28 days before the first dose; palliative radiotherapy within 14 days before the first dose; or certain radioactive medicines within 56 days before the first dose.
- People who have received systemic cancer treatments within 28 days before the first dose (including chemotherapy, immunotherapy, large-molecule targeted therapies, or biological treatments such as cancer vaccines or growth factors); or small-molecule targeted therapies or certain oral chemotherapy within 14 days or 5 half-lives (whichever is longer); or specific chemotherapy agents (mitomycin C or nitrosoureas) within 6 weeks before the first dose.
- People who have received a live attenuated vaccine (a type of vaccine made from a weakened live virus or bacteria) within 28 days before the first dose, or who plan to receive one during the study.
- People who have had an active infection requiring antibiotic or antiviral treatment given through a drip (intravenous infusion) within 28 days before the first dose.
- People who have taken certain traditional Chinese patent medicines approved by a Chinese regulatory body (the NMPA) that are listed as having anti-cancer uses, or Chinese herbal medicines recorded as being used for anti-cancer purposes, within 14 days before the first dose.
- People who have had a whole blood or blood component transfusion within 14 days before the first dose.
- People who have taken steroid medicines (at a dose equivalent to more than 10 mg per day of prednisone) or other medicines that suppress the immune system within 14 days before the first dose.
- People who have taken part in another clinical trial and received an experimental treatment within 28 days before the first dose, based on the date of the last treatment in that previous trial — except for people who are only being followed up for survival in a previous study.
- People who test positive for HIV or syphilis; people who test positive for hepatitis B with virus levels above the laboratory's normal range; or people who test positive for hepatitis C with virus levels above the laboratory's normal range.
- People with a history of active tuberculosis.
- People who are pregnant or breastfeeding.
- People who have had another cancer that was active or being treated within the 5 years before screening — except for certain skin cancers, a superficial type of bladder cancer, or cancers that were fully treated and considered cured (such as breast carcinoma in situ).
- People with any other condition that the trial doctor believes may increase risks, affect how results are interpreted, affect ability to follow the study requirements, or otherwise make participation unsuitable.
- People with a clinically significant digestive system condition, including liver disease, bleeding, inflammation, blockage, or significant diarrhoea.
- People who are currently using or have used certain medicines in the past 2 weeks that strongly affect the way the body processes drugs (called strong CYP3A enzyme inducers or inhibitors, and/or strong UGT1A inhibitors) (confirm with trial site).
- People who have previously been treated with liposomal irinotecan or irinotecan (specific chemotherapy medicines).
- People who, in the trial doctor's judgement, are not suitable for this study for any 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.
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
30 May 2026
Est. completion
30 May 2027
Primary endpoints
Objective Response Rate
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.
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.