Printed from Voxsanity (voxsanity.com.au) — NCT07634094 — 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
NCT07634094
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 advanced stage (Stage III or IV) ovarian, fallopian tube, or peritoneal cancer of a specific type (epithelial carcinoma or carcinosarcoma).
- A pathology report confirming the diagnosis of the original tumour is required.
- People whose cancer treatment plan includes chemotherapy given before surgery (called neoadjuvant chemotherapy) as the main treatment approach.
- People who have not yet received any chemotherapy and are starting treatment for the first time in the neoadjuvant (pre-surgery) setting.
- People who are in good general health and able to carry out daily activities with little or no limitation, as measured by a standard medical scoring tool (ECOG score of 0 or 1).
- People who are considered suitable candidates for surgery to remove as much tumour as possible (interval debulking surgery) and for a specific type of chemotherapy delivered directly into the abdomen, with no significant history of abdominal scarring, active abdominal wall infections, serious kidney disease, or bowel blockage.
- People who have at least one tumour area large enough to be biopsied and removed to provide more than 2 grams of tumour tissue for use in the study, as determined by the treating doctor or surgeon.
- People who have cancer that can be measured using a specific set of imaging guidelines (iRECIST criteria).
- People who are sexually active and able to have children, along with their partners, must agree to use highly effective contraception before, during, and for a set period after the last dose of treatment, plus an additional barrier method (such as a condom); men must also agree not to donate sperm and women must agree not to donate eggs during these same periods.
- Women who could potentially become pregnant must not be pregnant or breastfeeding at the time of screening; women are considered to be in this category unless they have had a permanent sterilisation procedure (such as removal of the uterus, both fallopian tubes, or both ovaries) or have documented menopause (no menstrual period for 12 months in a woman over 45 years old, with no other medical explanation).
- People who are willing to undergo a procedure called leukapheresis, where white blood cells are collected from the blood.
- People who are willing and able to follow all requirements of the study protocol.
- People whose blood, kidney, and liver are functioning well enough to meet the following specific test result thresholds (confirm exact values with trial site):
- Adequate bone marrow function, including sufficient white blood cell counts, platelet levels, and haemoglobin levels.
- Adequate kidney function based on a blood test (creatinine level).
- Adequate liver function based on blood tests (bilirubin, liver enzyme levels).
- People who have signed a consent form agreeing to participate and allowing their personal health information to be used.
- People who are 18 years of age or older.
- People who are able to swallow oral medication and have no concerns about absorbing it, as determined by the treating doctor.
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 classified as a sarcoma.
- People who have an active autoimmune disease, such as rheumatoid arthritis, lupus, ulcerative colitis, Crohn's disease, multiple sclerosis, or ankylosing spondylitis.
- People who have a known allergy to cisplatin or taxane chemotherapy drugs (people with a carboplatin allergy may still be considered if they tolerate a test dose of cisplatin given under monitored conditions; people allergic to paclitaxel may be considered for an alternative drug — confirm with trial site).
- People who are currently taking immunosuppressive medications on an ongoing basis, such as cyclosporin, ACTH, or regular steroid tablets (people who received a short, low-dose course of steroids, such as for a contrast dye allergy, may still be considered after confirmation by the principal investigator).
- People who have a known immune system deficiency condition, whether acquired, inherited, or present from birth, including conditions that affect the immune cells or the body's ability to produce normal antibodies.
- People who have other serious medical conditions that are not well controlled (aside from their cancer).
- People who have medical reasons why they cannot take anti-inflammatory medications (NSAIDs), such as chronic kidney failure, coronary artery disease, or bleeding stomach ulcers.
- People who have medical reasons why they cannot receive a medication called interferon α-2b, including a known allergy to interferon-alpha, autoimmune hepatitis, or severe liver disease.
- People whose tumours are classified as low malignant potential (borderline), except in specific circumstances involving ovarian pseudomyxoma or peritoneal disease (confirm with trial site).
- People who have had another type of invasive cancer (other than certain non-melanoma skin cancers) within the past five years, or whose previous cancer treatment would conflict with this study's treatment plan.
- People who have previously received radiation therapy to the pelvic area.
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: Robert Edwards, MD, UPMC Magee Womens Hospital
Phone: 4126412357
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
Kalinski, Pawel, MD, PhD
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 August 2028
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Dose Limiting Toxicities (DLT); Complete Pathologic Response (pCR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.