The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer

This is a Phase Ib evaluation of the combination of an antibody immunization vaccine strategy using oregovomab and an investigational stage immune adjuvant (poly ICLC / Hiltonol), both of which have previously been used in combination with other cancer treatments and demonstrated to be bioactive in advanced cancer, but which have not previously been combined together. The doses selected for each agent have been selected previously through human clinical study for use in immunization protocols as a well-tolerated and bioactive immune stimulatory dose. For immunization purposes a maximum tolerated dose is not a relevant pharmacologic objective. Rather this is an exercise in efficiently assessing a preliminary immunization protocol as a cost effective product development strategy assessing the ability of the combination to safely augment the immune signals measurable with either agent alone, both of which have been titrated to the current dose based on the principle of bell shaped dose response in immunization in prior studies. Subjects with stable disease for whom a 12 week break from cytotoxic therapy for their persistent and progressive advanced ovarian cancer is appropriate, who have signed informed consent and for whom baseline clinical information including laboratory, radiologic and physical documentation of their status is completed, will receive 4 cycles of oregovomab/Hiltonol immunization every three weeks (weeks 0, 3, 6, and 9). Blood will be obtained for the measurement of CA125 specific T cell immunity at 12 weeks before initiating continuing salvage therapy according to the best clinical judgment of the investigator. At week 16 the subjects will receive a final immunization with oregovomab/Hiltonol and at week 17 an additional blood draw for analysis of T-cell immunity.