Clinical Trials

Title   A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response following Surgery and Primary Chemotherapy (VITAL) - (CL-PT
Description   This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study of maintenance Vigil Ovarian (gemogenovatucel-T) in women with Stages IIIb, IIIc or IV high-grade papillary serous/clear cell/endometrioid ovarian, fallopian tube or primary peritoneal cancer. Subjects will have had a minimum of 4 and a maximum of 12 doses of Vigil prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking or initial diagnostic/evaluative laparoscopy (tissue for immunotherapy manufacture must be procured prior to initiation of neoadjuvant chemotherapy). An equal number of placebo doses will manufactured. Subjects will have achieved a clinically defined complete response following primary surgery and adjuvant chemotherapy.
IRB Number   15-138
Treatment   Oncology - Ovarian Cancer
Status   Active
Principal Name   Rodney Rocconi, M.D.
Contact Name   Kathleen Ollis

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