OncoMatch/Clinical Trials/NCT06915025
Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer
Is NCT06915025 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for epithelial ovarian cancer.
Treatment: IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) · Paclitaxel · Carboplatin · Olaparib · Niraparib — This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Disease stage
Required: Stage IIIB, IIC, IV (FIGO)
Grade: high-grade
Stage IIIB/C or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: IMNN-001 (IMNN-001)
prior treatment with IMNN-001
Cannot have received: immunotherapy
Prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., immunotherapy, anticancer therapy, surgery, radiation therapy)
Cannot have received: anticancer therapy
Prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., immunotherapy, anticancer therapy, surgery, radiation therapy)
Cannot have received: surgery
Prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., immunotherapy, anticancer therapy, surgery, radiation therapy)
Cannot have received: radiation therapy
Prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., immunotherapy, anticancer therapy, surgery, radiation therapy)
Cannot have received: chemotherapy
prior chemotherapy for any abdominal or pelvic tumor
Cannot have received: radiation therapy
Exception: Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed at least 3 years prior to registration, and the participant remains free of recurrent or metastatic disease.
prior radiotherapy to any portion of the abdominal cavity or pelvis is excluded
Cannot have received: chemotherapy
Exception: Prior adjuvant chemotherapy for localized breast cancer, if it was completed at least three years prior to registration, and that the participant remains free of recurrent or metastatic disease.
prior chemotherapy for any abdominal or pelvic tumor is excluded
Cannot have received: bevacizumab (bevacizumab)
will receive bevacizumab with the neoadjuvant or adjuvant treatment, or as maintenance will be excluded
Lab requirements
Blood counts
ANC ≥ 1,500/µl (exceptions for benign ethnic neutropenia >800/ul with approval; not induced/supported by G-CSF). Platelets ≥ 100,000/µl.
Kidney function
eGFR > 60 ml/min/1.73m2
Liver function
Bilirubin ≤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN. Exceptions due to hepatic metastases can be considered in consultation with medical monitor.
adequate: Bone marrow function: ANC ≥ 1,500/µl ... Platelets ≥ 100,000/µl. Renal function: eGFR > 60 ml/min/1.73m2. Hepatic function: Bilirubin ≤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN. Exceptions due to hepatic metastases can be considered in consultation with medical monitor.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Advent Health · Orlando, Florida
- Washington University School of Medicine in St. Louis · St Louis, Missouri
- Providence Cancer Institute · Portland, Oregon
- Sanford Health · Sioux Falls, South Dakota
- Erlanger Health · Chattanooga, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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