A Randomized Phase III Trial Evaluating the Safety and Efficacy of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Standard Neoadjuvant and Adjuvant Chemotherapy in Newly Diagn

Protocol No

IMUNON-IMNN-001-OVATION-3

Staff Member

William Bradley

Phase

III

Summary

The purpose of this study is to test the safety and effectiveness of IMNN-001 when given in combination with the standard of care (SOC) chemotherapy. Currently, the SOC for ovarian cancer includes chemotherapy (carboplatin and paclitaxel every 3 weeks for a total of 3 administrations), then surgery to remove cancerous tissue, followed by additional chemotherapy (carboplatin and paclitaxel every 3 weeks for a total of 3 administrations). In this study, we are comparing this standard of care protocol to the same standard of care with the addition of IMNN-001.

Objective

Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer (OVATION-3)

Status

OPEN TO ACCRUAL