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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT07637851
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 have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer confirmed by laboratory tissue analysis — including high-grade serous, endometrioid, or carcinosarcoma (with at least 30% epithelial tumour component) types.
- People aged 18 years or older.
- People whose cancer is at an advanced stage (stage III or IV).
- People who have received 3 or 4 standard pre-surgery chemotherapy cycles (carboplatin and paclitaxel, given every 3 weeks), and whose cancer showed two specific unfavourable signs: a poor response to chemotherapy based on a blood marker calculation (CA-125 KELIM score below 1.0), and cancer that could not be fully removed by surgery or that surgeons determined cannot be fully removed.
- People whose cancer can be measured and tracked using standard imaging scans (such as CT scan, PET scan, or MRI).
- People who can provide a tumour tissue sample (either stored from a previous procedure or from a new biopsy or surgery) for research purposes.
- People with a good general level of physical functioning, as assessed by a standard medical scale (ECOG score of 0 or 1).
- People whose BRCA gene mutation and HRD (tumour repair ability) status is known or will be tested before the maintenance phase of the trial.
- People with adequate bone marrow function, meaning blood counts meet minimum levels: haemoglobin at least 8 g/dL (without a recent blood transfusion in the past 3 weeks), white blood cell count (neutrophils) at least 1,500 cells/mm³, and platelets at least 100,000/mm³.
- People with adequate kidney and liver function, including specific blood test results within acceptable ranges for liver enzymes, bilirubin, albumin, and kidney filtration rate (confirm with trial site for exact values).
- People with adequate heart function, specifically a heart pumping strength (LVEF) of at least 50% on an echocardiogram, and troponin levels within or near the normal range (borderline cases may be assessed by a heart specialist before a decision is made).
- People with a life expectancy of at least 3 months.
- People who have given written consent to participate in the study.
- People who are covered by a social insurance scheme.
- People who are willing and able to attend scheduled visits, treatments, and follow-up appointments for the full duration of the trial.
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 cancer is a low-grade, clear cell, mucinous, or sarcomatous type, or a mixed tumour containing any of these types, or a low-grade or borderline ovarian tumour.
- People whose cancer continued to grow and spread during pre-surgery chemotherapy (platinum-refractory disease).
- People who have a medical reason that prevents them from receiving ubamatamab (the study drug).
- People who have a medical reason that prevents them from receiving carboplatin, paclitaxel, or bevacizumab.
- People who received bevacizumab during their initial pre-surgery chemotherapy.
- People who have previously been treated with anti-PD-1 therapies, T-cell therapies, or any other experimental anti-cancer treatment.
- People with a second cancer diagnosis, unless it is a non-melanoma skin cancer that has been adequately treated, a cervical cancer fully treated and in remission, or another solid cancer that was fully treated with no signs of return for at least 2 years.
- People with brain metastases, unless all of the following apply: the brain metastases have been treated locally and have caused no symptoms for at least 4 weeks before enrolment; there are no ongoing neurological symptoms related to the brain disease; and the person is either not on steroids or is on a stable or reducing low dose (less than 10 mg daily of prednisone or equivalent).
- People who have had brain inflammation (encephalitis), meningitis, or uncontrolled seizures in the year before giving consent.
- People who have received systemic chemotherapy or radiotherapy (other than for symptom relief) within 3 weeks before the first dose of the study drug.
- People with ongoing significant side effects (grade 3 or above on a standard toxicity scale) from previous cancer treatment.
- People currently receiving other experimental treatments.
- People with bowel blockage, inflammatory bowel disease, immune-related bowel inflammation, or other gut conditions that prevent them from taking oral medication or absorbing it properly.
- People with serious active heart conditions, including: a heart attack within the past 6 months; any history of heart muscle inflammation (myocarditis); significant heart rhythm problems; signs of active chest pain (angina) or heart failure; heart pumping strength below 50%; certain abnormal heart electrical readings (QTc interval above 470 milliseconds on repeated testing); specific types of heart conduction block (second-degree Mobitz type II or complete heart block); or elevated troponin levels above normal (borderline cases may be reviewed by a heart specialist).
- People with untreated blood clots in the lungs (pulmonary embolism) or legs (deep vein thrombosis) that are not being managed with blood-thinning medication.
- People with ongoing or recent (within the past 5 years) significant autoimmune disease that required treatment with immune-suppressing medication — though some conditions such as vitiligo, resolved childhood asthma, thyroid conditions requiring only hormone replacement, type 1 diabetes, or psoriasis not needing systemic treatment are not excluded.
- People with uncontrolled HIV, hepatitis B, or hepatitis C infection, or a known immune deficiency condition, or known latent tuberculosis — though people with well-controlled HIV, hepatitis B, or hepatitis C (meeting specific viral load and treatment criteria) may still be eligible (confirm with trial site).
- People with other active infections that required hospitalisation or intravenous antibiotics within 2 weeks before starting the study treatment.
- People who have received a live vaccine within 30 days before the planned start of treatment.
- People who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
- Women of childbearing potential who are not willing to use highly effective contraception before, during, and for at least 6 months after the last dose of study treatment (acceptable methods include certain hormonal contraceptives, intrauterine devices, surgical sterilisation, or a vasectomised sole partner — confirm with trial site for full details).
- People with a known psychiatric condition that would make it difficult to follow the trial requirements.
- People who are deprived of their liberty, or who are under legal guardianship or curatorship.
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.
Contact this trial
Principal Investigator: Benoit YOU, HCL - Centre Hospitalier Lyon Sud
Phone: 01 84 85 20 09
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
ARCAGY/ GINECO GROUP
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 September 2028
Where this trial is recruiting
🇫🇷 France
Primary endpoints
Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period; Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period; Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period; Efficacy phase II part
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 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.