IRB #

STUDY00015737

Title

(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

Principal Investigator

Tanja Pejovic

Study Purpose

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.

Medical Condition(s)

Ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer

Eligibility Criteria

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

Age Range

18 - 99

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

Yukie Tarumi Bean, CCRP
Gyn/Onc Study Coordinator
503-418-4522

Sponsor

ImmunoVaccine Technologies Inc.
(Supported by: Incyte Corp., provider of epacadostat)

Recruitment End

02/19/2018

Compensation Provided

No


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