A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects With Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy

⁃ Subjects will be eligible for tissue procurement for the Vigil manufacturing process if they meet all of the following criteria:

• Presumptive Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal cancer.

• No chemotherapy prior or investigational agents prior to tissue acquisition for Vigil manufacture.

• No other malignancy (excluding surgically cured nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.

• Anticipated availability of a cumulative mass of \

⁃ 30 grams tissue (golf-ball size or approximately 3cm disease on CT scan) at time of diagnostic laparoscopy or primary surgical debulking. Infiltrating lumen (bowel, fallopian tube, urethra) tissue should not be used as Vigil immunotherapy material to minimize risk of bacterial contamination.

• ECOG performance status (PS) 0-2 prior to diagnostic laparoscopy or debulking laparotomy.

• No prior history of hypersensitivity reactions (HSR) with taxanes or platinums.

• No prior history of allergies or sensitivities to gentamicin.

• Female, 18 years of age or older.

• Ability to understand and the willingness to sign a written informed consent document for tissue harvest.

⁃ Subjects will be registered in this study if they meet all of the following inclusion criteria:

• Histologically confirmed Stage IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal.

• Completion of primary surgical debulking including hysterectomy and bilateral salpingo oophorectomy, and at least 5 but no more than 8 cycles of platinum / taxane adjuvant chemotherapy or chemotherapy as per Category 1 recommendations of the NCCN guidelines, including 5-8 cycles adjuvant intraperitoneal + intravenous (IP/IV) chemotherapy, or 5-8 cycles of intravenous chemotherapy divided and administered as neoadjuvant and adjuvant therapy flanking primary debulking surgery.

• Clinically defined complete response (cCR) following completion of primary surgical debulking and eligible chemotherapy. cCR defined as no evidence of malignancy on chest x-ray (CT scan is acceptable) and CT scan or MRI of the abdomen and pelvis, normal physical examination, CA-125 antigen level ≤ 35 U/ml (assessed ≥ 2 weeks following removal of catheter in subjects receiving intraperitoneal/intravenous chemotherapy) and no findings on physical examination or symptoms suggestive of active cancer.

• Subjects must have initiated adjuvant chemotherapy no more than 8 weeks following primary debulking surgery.

• Successful manufacturing of at least 4 doses (vials) of Vigil and placebo.

• Recovered from all clinically relevant toxicities related to prior therapy (including neuropathy ≤Grade 2).

• ECOG performance status (PS) 0-1.

• Normal organ and marrow function as defined below: Absolute granulocyte count ≥ 1,500/mm\^3, Absolute lymphocyte count ≥ 500/mm\^3, Platelets ≥ 75,000/mm\^3, Total bilirubin ≤ 2 mg/dL, AST(SGOT)/ALT(SGPT)≤ 2x institutional upper limit of normal, Creatinine \< 1.5 mg/dL

• Ability to understand and the willingness to sign a written informed protocol specific consent.