TP022/#1424 A phase I/II study evaluating intraperitoneal GEN-1 in combination with neoadjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer
Objectives GEN-1, an IL-12 DNA plasmid formulated with a synthetic carrier is being evaluated with neoadjuvant platinum-taxane chemotherapy (NACT) in patients with advanced epithelial ovarian cancer. OVATION 2 is a multi-center, randomized, open-label phase I/II study evaluating the safety, anti-tumor activity, and immunological response to GEN-1 at a dose of 100 mg/m2 intraperitoneal (IP) actively enrolling at 20 centers in USA and Canada. Methods Up to 130 patients will be randomized 1:1 to receive either NACT plus GEN-1 or NACT alone. The phase I portion will evaluate safety in at least 6 patients administered in 8 weekly infusions starting at cycle 1 week 2 in combination with three 21-day cycles of carboplatin AUC 6 with paclitaxel 175 mg/m2 (PC). Following interval cytoreductive surgery an additional 9 weekly GEN-1 IP infusions starting at cycle 4 week 1 with three 21-day cycles of PC. If no dose limiting toxicities are found, then the study will continue into the phase II portion. To evaluate biological activity a subgroup of patients will have tumor tissue at initial biopsy/laparoscopy collected and at interval cytoreductive surgery. Tissue will be analyzed for the density of CD8, FoxP3, IDO-1, PD-1, and PDL-1 cells. Blood, peritoneal fluid/wash will be collected before and after treatment in a subgroup of patients to quantify for levels of IFN-g. The primary endpoint is PFS. Results Trial in progress: there are no available results at the time of submission. Conclusions Trial in progress: there are no available conclusions at the time of submission.
Women & Children
Earle A. Chiles Research Institute
Obstetrics & Gynecology
Thaker, Premal; Bergman, Melanie; and See all authors in comments, "TP022/#1424 A phase I/II study evaluating intraperitoneal GEN-1 in combination with neoadjuvant chemotherapy in patients newly diagnosed with advanced epithelial ovarian cancer" (2022). Articles, Abstracts, and Reports. 6871.
Presented at the IGCS Annual Global Meeting; September 29-October 1; New York City, NY. International Journal of Gynecological Cancer Society. 2022;32(Suppl 3): 1424. doi: 10.1136/ijgc-2022-igcs.531. Authors: Premal Thaker1, Debra Richardson2, William Bradley3, Lindsay Kuroki1, Robert Holloway4, Stephen Depasquale5, Mark Reed6, Amy Bregar7, Jennifer Scalici8, Melanie Bergman9, Charles Leath Iii10, Maria Bell11, Christopher Darus12, Karen Finkelstein13, Bhavana Pothuri14, David Warshal15 and Nicholas Borys16