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

Exclusion Criteria18

• Participant who has received prior treatment with IMNN-001.
• Participant who has received oral or parenteral corticosteroids (\>10 mg prednisone) within 2 weeks of first dose of IMNN-001 (if applicable) or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.
• Participant has mucinous, germ cell, transitional cell, clear cell, undifferentiated, or non-epithelial ovarian cancer.
• Participant has low-grade or Grade 1 epithelial ovarian cancer.
• Participant of childbearing potential, not practicing adequate contraception, participant who is pregnant, or participant who is breastfeeding are not eligible for this trial.
• Participant has a bowel obstruction by clinical symptoms or computed tomography (CT) scan, sub-occlusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess.
• Participant has been diagnosed and/or treated with any therapy for invasive cancer \<3 years from study enrollment, completed adjuvant chemotherapy and/or targeted therapy at least 3 years from enrollment, or completed adjuvant hormonal therapy less than 4 weeks from enrollment.
• Participant with definitively treated non-invasive malignancies such as cervical carcinoma in situ, ductal carcinoma in situ, grade 1 or 2 Stage IA endometrioid endometrial cancer, or non-melanomatous skin cancer are allowed.
• Participant with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the participant to extreme risk or decreased life expectancy.
• Participant has known active hepatitis or HIV with detectable viral load.
• Participant has a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, IMNN-001, or their excipients.
• Prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., immunotherapy, anticancer therapy, surgery, radiation therapy).
• Participant is receiving treatment for active autoimmune disease. "Active" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.
• Participant who has received prior radiotherapy to any portion of the abdominal cavity or pelvis is excluded. 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.
• Participant who has received prior chemotherapy for any abdominal or pelvic tumor is excluded. Participant may have received 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.
• Participant with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
• Participant who will receive bevacizumab with the neoadjuvant or adjuvant treatment, or as maintenance will be excluded.
• Participant with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including abdominal surgery within 4 weeks of study entry (for reason other than IP port placement or laparoscopic diagnosis of epithelial ovarian cancer), intestinal dysfunction as defined in #6 above.