A Phase II randomized trial to evaluate the safety, efficacy and immunogenicity of vaccination with Folate Receptor Alpha peptides admixed with GM-CSF as a vaccine adjuvant versus GM-CSF alone in patients with Platinum Sensitive Ovarian Cancer and a response or stable disease to platinum therapy (Tapimmune FRV-004)
This is a double-blind, randomized, parallel groups Phase II trial. Patients with platinum-sensitive advanced ovarian cancer, defined as a lack of progression by RECIST v1.1 criteria following completion of standard-of-care chemotherapy, including a minimum of 4 cycles of a platinum-containing regimen. Patients will be randomized to either the vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy within one year of the last administration of platinum, targeting the first remission.