MC220601, Folate Receptor Alpha Dendritic Cells (FRαDCs) Plus Pembrolizumab for Patients With Advanced Stage Ovarian Cancer (FRAPPE)
This phase I/II trial tests the safety, side effects, best dose, and effectiveness of multi-epitope folate receptor alpha-loaded dendritic cell vaccine (FRalphaDC) with pembrolizumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer (collectively known as ovarian cancer) that that has come back (after a period of improvement) (recurrent). Ovarian cancer is the most lethal gynecologic malignancy in the United States. While the majority of patients achieve a remission from ovarian cancer with the combination of aggressive cytoreductive surgery and cytotoxic chemotherapy, over 80% of patients develop recurrence within 3 years of completion of treatment. Additional treatments are needed for recurrence, but the standard treatment modalities are non-curative in nature due to the development of drug resistance. As such, there is a great unmet need for treatment strategies that utilize new mechanisms to which drug resistance does not develop. FRalphaDC is a dendritic cell vaccine that is made from the white blood cells collected from a procedure call apheresis. The white blood cells are treated to make dendritic cells, which will then be incubated with peptides, which are pieces of a protein known as folate receptor alpha (FRalpha), a protein that is found in high levels on ovarian cancer cells. Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the tumor cells by targeting the FRalpha protein. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving FRalphaDC vaccine with pembrolizumab may be a safe and effective treatment for recurrent ovarian cancer.
• Age \>= 18 years
• Histologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer NOTE: Histologic confirmation of the primary tumor or recurrent tumor per pathology report is required. Eligible histotypes include high grade serous; endometrioid; and clear cell carcinoma, as these histotypes have high expression of FRalpha. Mixed carcinomas, including carcinosarcomas, with \>= 50% of the tumor comprised of high grade serous; and/or endometrioid; and/or clear cell carcinoma are eligible
• Ovarian cancer (OC) recurrence - Platinum sensitivity/resistance
‣ Platinum-refractory (defined as recurrence or progression of OC =\< 30 days of the last dose of platinum-based chemotherapy)
⁃ Platinum-resistant (defined as recurrence or progression of OC between 31-180 days of the last dose of platinum-based chemotherapy)
⁃ Platinum-sensitive (defined as recurrence or progression \>=181 days after the last dose of platinum-based chemotherapy).
∙ NOTE: Any number of prior therapies or maintenance regimens for OC are allowed
• At least one of the following:
‣ Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria AND/OR
⁃ CA-125-evaluable disease, as defined by the Gynecologic Cancer InterGroup (GCIG)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Hemoglobin \>= 8.5 g/dL (obtained =\< 15 days prior to registration)
• Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 15 days prior to registration)
• Platelet count \>= 75,000/mm\^3 (obtained =\< 15 days prior to registration)
• Lymphocytes \>= 0.3 x 10\^9/L (obtained =\< 15 days prior to registration)
• Monocytes \>= 0.25 x 10\^9/L (obtained =\< 15 days prior to registration)
• Total bilirubin =\< 1.5 x upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin must be =\< ULN (obtained =\< 15 days prior to registration)
• Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 15 days prior to registration)
• Creatinine clearance \>= 30 mL/min per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (obtained =\< 15 days prior to registration)
• Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
• Provide written informed consent
• Willing to provide mandatory blood and tissue specimens for correlative research
• Willing to provide archival tissue specimen for correlative research
• Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)
• Willing to undergo a tetanus vaccination (if not performed =\< 365 days prior to registration)
• Willing to have a temporary central access line placed for apheresis, if needed