(ONC-DPX-Survivac-06): A Phase 1b Study of an Immunotherapeutic Vaccine, DPX-Survivac with Low Dose Cyclophosphamide and Epacadostat (INCB024360) in Patients with Recurrent Ovarian Cancer
To determine the safety of combining an investigational cancer vaccine, DPX-Survivac, with FDA-approved low-dose cyclophosphamide and an investigational oral immune enhancing drug, epacadostat, in women with recurrent ovarian cancer.
Fallopian tube cancer
Primary peritoneal cancer
1. Confirmed diagnosis of Stage IIc-IV epithelial ovarian, fallopian tube, or peritoneal cancer and completion of first-line treatment.
2. Evidence of progressive disease-- either by rising CA-125 and/or radiologic imaging-- at least 3 months after completion of first-line platinum-based chemotherapy (other therapies after first-line are allowed).
3. Must be willing to have a pre-treatment tumor biopsy performed, and be willing to undergo tumor biopsy during treatment as well.
4. Other criteria will apply
18 - 99
Healthy Volunteers Needed
Duration of Participation
Treatment can continue for one year, or until subjects experience disease progression or develop intolerable side effects, whichever occurs first. After treatment, subjects will be followed every 6 months for 5 years.
Yukie Tarumi Bean, CCRP
Gyn/Onc Study Coordinator
ImmunoVaccine Technologies Inc.
(Supported by: Incyte Corp., provider of epacadostat)