Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer

Inclusion Criteria

• •1. Patients must have advanced stage (III-IV) epithelial carcinoma or carcinosarcoma of ovarian, tubal or peritoneal origin.
• •a. Histologic documentation of the original primary tumor is required via a pathology report.
• •2. Patients must be eligible for cancer-related definitive therapy with neoadjuvant chemotherapy.
• •3. Patients must be chemo-naive and receiving therapy in primary first-line neoadjuvant setting.
• •4. Patients must have ECOG performance of 0-1.
• •5. Patients must be reasonable candidate for interval debulking surgery as well as for IP platinum-based combination chemotherapy regimen, with no prior evidence of clinically significant intra-abdominal adhesions, persistent abdominal wall infections, renal disease or bowel obstruction.
• •6. At least one lesion must be considered to be large enough for biopsy and resection to yield greater than 2 grams of tumor for tumor loading of αDC1's and immunoassays at the discretion of the treating investigator and/or surgeon.
• •7. Patients must have measurable disease per iRECIST criteria.
• •8. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.
• •9. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:
• •a. Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
• •10. Patients must be willing to undergo leukapheresis.
• •11. Patients must be willing to adhere to protocol requirements.
• •12. Patients must have adequate:
• •1. Bone marrow function:
• •* Absolute neutrophil count (ANC) greater than or equal to 1,500/μL
• •* Platelets greater than or equal to 100,000/μL
• •* Hemoglobin greater than or equal to 8.0 g/dL
• •2. Renal function:
• •\- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
• •3. Hepatic function:
• •* Bilirubin less than or equal to 1.5 x ULN
• •* SGOT and alkaline phosphatase less than or equal to 2.5 x ULN
• •13. Patients who have signed informed consent and authorization permitting release of personal health information.
• •14. Patients must be ≥ 18 years of age.
• •15. Patient must be able to swallow oral medication and have no absorption related medical concern as deemed by the investigator.