Phase 3 Ovarian Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are female and aged 18 or older, able to understand the study procedures, and willing to give written consent to participate.
• People who have been diagnosed through a tissue biopsy with a specific type of high-grade ovarian, fallopian tube, or peritoneal cancer (types include serous, endometrioid, carcinosarcoma, or mixed epithelial), at an advanced stage (Stage IIIB, IIIC, or IV).
• People whose doctors consider them suitable to receive chemotherapy before surgery (called neoadjuvant chemotherapy).
• People who are able to provide a tumor tissue sample before or at the start of the study, collected through keyhole surgery or a needle biopsy, to test for a specific biological marker.
• People of childbearing potential who have a negative pregnancy blood test within 14 days before starting treatment, are using effective contraception, and are not breastfeeding at the time of joining.
• People whose blood counts, kidney function, liver function, and nerve function all meet the minimum levels required by the trial (confirm specific values with the trial site).
• People with a general health/activity score of 0, 1, or 2 on a standard scale used in cancer trials (called the ECOG scale), meaning they are fully active to somewhat limited in strenuous activity (confirm with trial site).
• People who have not had an active infection requiring intravenous antibiotics or a serious uncontrolled illness in the 4 weeks before joining.
• People who have stopped any hormone therapy aimed at treating the cancer at least one week before starting treatment — though general hormone replacement therapy is allowed to continue.

Who may not be able to join:

• People who have previously been treated with the study drug IMNN-001.
• People who have taken steroid medications (such as prednisone at more than 10 mg) in the 2 weeks before the first dose, or who need ongoing steroid or immune-suppressing treatment for a long-term condition unrelated to chemotherapy.
• People whose ovarian cancer is of the mucinous, germ cell, transitional cell, clear cell, undifferentiated, or non-epithelial type.
• People who have low-grade or Grade 1 epithelial ovarian cancer.
• People who are pregnant, breastfeeding, or not using adequate contraception.
• People who have a bowel blockage, certain bowel or abdominal conditions such as a fistula, perforation, or internal abscess, as identified by symptoms or a CT scan.
• People who have been diagnosed with or treated for another invasive cancer within the past 3 years, or who finished adjuvant chemotherapy or targeted therapy less than 3 years ago, or finished adjuvant hormonal therapy less than 4 weeks ago.
• People with serious ongoing medical conditions unrelated to their cancer that could limit their ability to fully take part in the study or put them at significant risk.
• People with known active hepatitis or HIV with a detectable viral load.
• People with a known allergy or serious sensitivity to paclitaxel, carboplatin, IMNN-001, or any of their ingredients.
• People who have already received any treatment for their high-grade ovarian, fallopian tube, or peritoneal cancer, including immunotherapy, other cancer treatments, surgery, or radiation.
• People currently receiving treatment for an active autoimmune disease (such as lupus, multiple sclerosis, inflammatory bowel disease, or rheumatoid arthritis).
• People who have previously had radiation therapy to any part of the abdomen or pelvis — though prior radiation to the breast, head and neck, or skin may be allowed if it was completed at least 3 years ago and the cancer has not returned (confirm with trial site).
• People who have previously received chemotherapy for any abdominal or pelvic cancer — though prior chemotherapy for early breast cancer may be allowed if completed at least 3 years ago and the cancer has not returned (confirm with trial site).
• People with a history of brain tumours, brain metastases, uncontrolled seizures, stroke, mini-stroke (TIA), or bleeding around the brain within 6 months of starting the trial.
• People who will be receiving the drug bevacizumab as part of their neoadjuvant or adjuvant treatment, or as maintenance therapy.
• People with any physical condition or recent abdominal surgery (within 4 weeks) that would prevent the correct placement of the tube used to deliver the study drug directly into the abdomen.

Important: Always verify eligibility with the trial site directly before applying.