PT  - JOURNAL ARTICLE
AU  - Thaker, Premal
AU  - Richardson, Debra
AU  - Bradley, William
AU  - Kuroki, Lindsay
AU  - Holloway, Robert
AU  - Depasquale, Stephen
AU  - Reed, Mark
AU  - Bregar, Amy
AU  - Scalici, Jennifer
AU  - Bergman, Melanie
AU  - Iii, Charles Leath
AU  - Bell, Maria
AU  - Darus, Christopher
AU  - Finkelstein, Karen
AU  - Pothuri, Bhavana
AU  - Warshal, David
AU  - Borys, Nicholas
TI  - 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
AID  - 10.1136/ijgc-2022-igcs.531
DP  - 2022 Dec 01
TA  - International Journal of Gynecologic Cancer
PG  - A234--A234
VI  - 32
IP  - Suppl 3
4099  - http://ijgc.bmj.com/content/32/Suppl_3/A234.1.short
4100  - http://ijgc.bmj.com/content/32/Suppl_3/A234.1.full
SO  - Int J Gynecol Cancer2022 Dec 01; 32
AB  - 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.