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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT05479045
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 and willing to sign a consent form before any study-related procedures begin.
- Women aged 18 or older who have been diagnosed with stage III or IV ovarian cancer (adenocarcinoma type) that has stopped responding to platinum-based treatment within 6 months, and whose cancer can be measured using standard imaging guidelines, and who have already received standard treatment.
- People who have had a physical examination within 28 days before joining the study.
- People who have had imaging of their tumour(s) taken within 28 days before joining the study.
- People who have recovered from the effects of any recent surgery, radiation therapy, or chemotherapy.
- People who do not have an active infection currently requiring antibiotic treatment (a simple urinary tract infection is an exception).
- People who have stopped any hormone therapy aimed at the cancer at least one week before joining the study.
- People who have stopped any other previous cancer treatments — including chemotherapy, targeted therapy, biological therapy, immunotherapy, or experimental treatments — at least 4 weeks before joining (or 6 weeks for certain specific chemotherapy drugs called nitrosoureas or mitomycin C).
- People who completed any prior radiation therapy at least 4 weeks before joining the study.
- People for whom at least 4 weeks have passed since any major surgery.
- People whose cancer has progressed on, stopped responding to, or who could not tolerate standard platinum-based therapy, and who have received no more than 2 previous courses of systemic treatment for recurring or metastatic disease.
- People who have at least one tumour that can be measured using standard imaging guidelines (RECIST v1.1).
- People who have a previously treated (irradiated) tumour site that is clearly defined, measurable, and has visibly grown may have that site counted as a target lesion.
- People who are having a fresh tumour biopsy taken must have at least one additional tumour site that can be safely biopsied, as judged by the study doctor (this is optional).
- People who agree to provide stored tumour tissue samples for research purposes; if stored tissue is not available or suitable, people must agree to have a fresh biopsy taken.
- All participants are encouraged to agree to provide tumour tissue samples both before and during treatment (the on-treatment sample is optional).
- People with a physical functioning score (ECOG) of 2 or less, meaning they are reasonably mobile and capable of self-care.
- People who, in the study doctor's opinion, are likely to continue treatment for at least 8 weeks.
- People whose blood, kidney, and liver test results meet the required levels of healthy function as determined by specific laboratory measurements (confirm with trial site for exact values).
- Women who could become pregnant and are sexually active with a male partner must use at least one highly effective form of contraception from the screening period and for 180 days after the last dose of the study drug; their male partner must also use a condom throughout this period.
- Women who are considered able to become pregnant are those who have not had their tubes tied, both ovaries removed, or a full hysterectomy, and who have not gone through menopause (defined as no periods for 12 months without another medical explanation).
- People who are not breastfeeding during the study and for 180 days after the last dose of the study drug.
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 have previously been treated with nivolumab, CTLA-4 blockers, PD-1, PD-L1, or PD-L2 blockers, or any other drug designed to target immune checkpoint pathways.
- People who have any condition that, in the study doctor's opinion, would interfere with assessing the study drug or interpreting safety results.
- People who have a history of severe allergic reactions (such as a life-threatening anaphylactic reaction that took more than 6 hours to recover from) to unknown substances or to any ingredient in the study drugs.
- People who have had an active or documented autoimmune disease (such as inflammatory bowel disease, coeliac disease, or Wegener's granulomatosis) within the past 2 years (certain stable or mild autoimmune conditions may not be excluded — confirm with trial site).
- People who are currently enrolled in another interventional clinical trial (participation in an observational study or follow-up phase of a previous trial may be acceptable).
- People who have received any standard or experimental cancer treatment within 28 days before the first study dose (or within 28 days or 5 half-lives, whichever is shorter, for monoclonal antibody treatments).
- People who are currently receiving any chemotherapy, immunotherapy, biological therapy, or hormonal therapy for cancer (use of hormones for non-cancer conditions such as insulin or hormone replacement therapy is acceptable).
- People who still have unresolved side effects from previous cancer treatments that have not returned to mild or absent levels, with the exception of hair loss and certain lab values (some permanent side effects that are not expected to worsen may be considered — confirm with trial site).
- People who have used immunosuppressive medications within 14 days before starting treatment (certain low-dose or localised steroid uses are exceptions — confirm with trial site).
- People who have a history of a primary immune system deficiency, have received a solid organ transplant, or have a history of tuberculosis.
- People whose test results show an active hepatitis B or C infection, or who have a known HIV infection.
- People who have received a live or live-attenuated vaccine within 28 days before the first dose of the study drug.
- People who are pregnant or breastfeeding.
- People who have had major surgery within 4 weeks before the first dose, or who are still recovering from prior surgery (minor local surgery for symptom relief may be acceptable).
- People who have had another invasive cancer diagnosed within the past 2 years (certain non-invasive cancers that have been surgically removed may be exceptions — confirm with trial site).
- People with serious uncontrolled health conditions, including active infections, unstable chest pain (angina), a history of heart muscle inflammation (myocarditis), a heart attack within the past 6 months, severe heart failure, serious heart rhythm problems requiring ongoing treatment, or mental health or social circumstances that would make it difficult to follow the study requirements — also people whose heart pumping function (LVEF) is below 50% on an echocardiogram.
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
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Georgetown University
Registry
ClinicalTrials.gov
Start date
1 September 2026
Est. completion
1 November 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Median Progression Free Survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 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.