Name of Protocol

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

Purpose

This is a 10-patient open label Phase Ib study to look at the combination of an antibody immunization vaccine strategy using oregovomab and an investigational stage immune booster (poly ICLC / Hiltonol). Each has been used alone and in combination with other cancer treatments demonstrating activity in advanced cancer, but they have not previously been used together. This study will assess whether these two drugs can safely improve the response seen with either drug alone, at doses that are based on the prior studies.

Trial Design

Patients will receive 4 cycles of oregovomab/Hiltonol immunization every three weeks (weeks 0, 3, 6, and 9). Blood will be obtained to evaluate CA-125 specific T-cell response. At week 16, the subjects will receive a final dose of the combination of oregovomab/Hiltonol and at week 17 will have an additional blood draw for analysis of T-cell response.

Timeline

Completion of enrollment is expected in August 2018 and the study is expected to be completed in September 2021.

Participating Centers

Dr. Robert Holloway


Dr. William P. McGuire