Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Inclusion criteria

• ✓. Subjects with ovarian, fallopian tube, or primary peritoneal carcinoma with high grade serous adenocarcinoma histology are eligible. Poorly differentiated carcinomas consistent with high grade serous histology are eligible. Pathologic diagnosis may be via frozen section or permanent pathology from diagnostic laparoscopy during the screening phase or via pre-enrollment core biopsy (but not cytology).
• ✓. Subjects must have an International Federation of Gynecology and Obstetrics (FIGO) stage of III or IV who based on standard of care clinical considerations have been recommended to undergo neoadjuvant therapy per standard clinical determination by their oncology provider.
• ✓. Subjects must have adequate: bone marrow function, renal function, hepatic function, and neurologic function.
• ✓. Subjects should be free of active infection requiring isolation, parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry. Subjects with diagnosis of COVID-19 infection must be 14 days after positive test or onset of symptoms.
• ✓. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.
• ✓. Subjects must have a performance status score of 0-1 by Eastern Cooperative Group (ECOG) criteria.
• ✓. Subjects of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and agree to practice an effective form of contraception. If applicable, subjects must discontinue breastfeeding prior to study entry.
• ✓. Subjects must have signed an IRB-approved informed consent.

Exclusion criteria