MC1963 Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for Patients With Advanced Stage Ovarian Cancer: A Phase II Double-Blind Randomized Clinical Trial (FAROUT)
This phase II trial compares the effect of folate receptor alpha dendritic cells (FRαDCs) to placebo in treating patients with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. FRαDCs, a dendritic cell vaccine, is made from a person's white blood cells. The white blood cells are treated in the laboratory to make dendritic cells (a type of immune cell) mixed with folate receptor alpha (FRalpha), a protein found in high levels on ovarian tumor cells. FRαDCs work by boosting the immune system to recognize and destroy the tumor cells by targeting the FRalpha protein on the tumor cell. Placebo is an inactive substance that looks the same as, and is given the same way as, the active drug or treatment being tested. The effects of the active drug are compared to the effects of the placebo. Giving FRαDCs may work better in preventing or delaying recurrence compared to placebo in patients with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.
• Age ≥ 18 years
• Histological confirmation of Federation of Gynecology and Obstetrics (FIGO) stage III or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. NOTE: Histologic confirmation of the primary tumor is required. Eligible histotypes include high grade serous; endometrioid; and clear cell carcinoma, as these histotypes have high expression of FRα (Kalli, Oberg, Keeney, \& et al., 2008). Mixed carcinomas, including carcinosarcomas, with ≥ 50% of the tumor comprised of high grade serous; and/or endometrioid; and/or clear cell carcinoma are eligible
• Completion of cytoreductive surgery and one (and only one) course of platinum-based chemotherapy (5-9 cycles) ≥ 4 but ≤ 12 weeks prior to registration
‣ NOTE: Cytoreductive surgery may have been prior to or after one or more cycles of chemotherapy and must include hysterectomy and bilateral salpingo-oophorectomy (if the uterus and/or ovaries were not previously removed)
⁃ NOTE: Patients may have had more than one chemotherapy regimen (examples: paclitaxel/carboplatin switched to docetaxel/carboplatin due to allergy; or weekly treatment switched to every 3-weekly treatment due to intolerance), but may not have received a separate course of treatment for recurrent OC
⁃ NOTE: Patients may receive both neoadjuvant and adjuvant chemotherapy provided both regimens are platinum-based and total nine (9) or fewer chemotherapy cycles
• Germline and somatic genetic testing have been completed
‣ NOTE: No pathogenic mutations of BRCA1/BRCA2 are allowed
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
• Expected survival ≥ 6 months
• Hemoglobin ≥ 8.5 g/dL (≤ 15 days prior to registration)
• Absolute neutrophil count (ANC) ≥ 1000/mm\^3 (≤ 15 days prior to registration)
• Platelet count ≥ 75,000/mm\^3 (≤ 15 days prior to registration)
• Lymphocytes ≥ 0.3 x 10\^9/L (≤ 15 days prior to registration)
• Monocytes ≥ 0.25 x 10\^9/L (≤ 15 days prior to registration)
• Total bilirubin ≤ upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin ≤ ULN (≤ 15 days prior to registration)
• Aspartate transaminase (AST) ≤ 3 x ULN (≤ 15 days prior to registration)
• Creatinine clearance ≥ 30 mL/min per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (≤ 15 days prior to registration)
• Provide written informed consent
• Willing to provide mandatory blood specimens for correlative research
• Willing to provide archival tissue specimen for correlative research
• Willing to return a participating institution 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 central access line placed, if needed (as determined during venous access assessment)