Phase III Study of Folate Receptor Alpha Dendritic Cell Vaccine with Pembrolizumab for Women With Recurrent Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

What this Trial Is About

Researchers are evaluating a combination of a multi-epitope folate receptor alpha-loaded dendritic cell vaccine FRalphaDC with pembrolizumab in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. This phase III trial aims to assess the safety, side effects, best dose, and effectiveness of this immunotherapy approach. Ovarian cancer often returns after initial treatment, and new treatments are needed to overcome drug resistance and improve outcomes. Participants will undergo apheresis to collect white blood cells used to create the FRalphaDC vaccine. They will receive the vaccine by intradermal injection and pembrolizumab by intravenous infusion in cycles every 21 days for up to eight cycles, followed by cycles every 42 days for up to 22 cycles if there is no disease progression or unacceptable toxicity. Imaging scans such as CT or MRI, blood samples, and biopsies will be performed throughout the study to monitor the cancer and immune response. Participants will be followed for safety and treatment response, with assessments including objective response rate, disease control, duration of response, progression-free survival, overall survival, and adverse event monitoring. Follow-up visits occur 90 days after the last dose, then every three months for two years, and every six months up to five years. Blood and tissue samples will be collected for research to study immune changes related to treatment.

Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer