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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.

Phase 3RecruitingImunonNCT06915025Data as of May 2026

Treatment: IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) · Paclitaxel · Carboplatin · Olaparib · NiraparibThis 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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