To distinct P2X7 Receptor Inhibitor Formulation tumors and antigens with out the want to manipulate the viral backbone. A phase I/II clinical trial is at present below preparation.P318 A phase II multicenter trial to evaluate efficacy and safety of HF10 oncolytic virus immunotherapy and ipilimumab in patients with unresectable or metastatic melanoma Robert HI Andtbacka1, Merrick Ross2, Sanjiv Agarwala3, Kenneth Grossmann1, Matthew Taylor4, John Vetto5, Rogerio Neves6, Adil Daud7, Hung Khong1, Stephanie M Meek8, Richard Ungerleider9, Scott Welden9, Maki Tanaka10, Matthew Williams11 1 University of Utah, Huntsman Cancer Institute, Salt Lake City, UT, USA; 2 Univesity of Texas MD Anderson Cancer Center, Houston, TX, USA; 3St. Luke’s Hospital, Easton, PA, USA; 4Oregon Wellness Science University, Portland, OR, USA; 5Knight Cancer Institute, Oregon Overall health and Science University, Portland, OR, USA; 6Pennsylvania State University, Hershey Cancer Institute, Hershey, PA, USA; 7UCSF Helen Diller Family Complete Cancer Center, San Francisco, CA, USA; 8University of Utah College of δ Opioid Receptor/DOR Inhibitor Molecular Weight Medicine, Salt Lake City, UT, USA; 9Theradex, Princeton, NJ, USA; 10Takara Bio, Inc., Otsu Shiga, Japan; 11University of Utah, Salt Lake City, UT, USA Correspondence: Scott Welden ([email protected]) Journal for ImmunoTherapy of Cancer 2016, four(Suppl 1):PJournal for ImmunoTherapy of Cancer 2016, 4(Suppl 1):Page 170 ofBackground HF10, an attenuated, replication-competent mutant strain of herpes simplex virus sort 1 (HSV1), is actually a promising new oncolytic viral immunotherapy. HF10 (intratumoral injection) shows activity in injected lesions and uninjected metastatic lesions. An ongoing phase II study in melanoma patients (pts) is assessing whether or not the mixture of HF10 as well as the immune checkpoint inhibitor ipilimumab (ipi) enhances the antitumor impact of HF10. Approaches Ipi na e pts with stage IIIB, IIIC or IV unresectable melanoma have been enrolled. HF10 was administered intratumorally into single or various tumors (1×107 TCID50/mL, as much as 5 mL/dose); 4 injections qwk; then up to 15 injections q3wk. Ipi was administered intravenously (three mg/kg), q3wk for four doses. Tumor responses (irRC) were assessed at 12, 18, 24, 36, and 48wks. Ideal Overall Response Price (BORR) was determined at 24wks. Serial peripheral blood and tumor biopsies were obtained and analyzed for adjustments in cytokines, immune profile and tumor microenvironment. Herein we present the security, efficacy, and preliminary correlative study results. Outcomes In total, 46 pts were enrolled, of which 20 have been stage IIIB, 43 stage IIIC, and 37 stage IV melanoma. Most HF10-related adverse events (AEs) had been G2, equivalent to HF10 monotherapy. No DLTs had been reported; three G4 AEs reported, all not therapy related. 30.4 had G3 AEs. HF10-related G3 AEs (n = three) had been left groin pain, thromboembolic occasion, lymphedema, hypoglycemia, and diarrhea. Of 44 efficacy evaluable pts, preliminary BORR at 24 wks was 42 and general study BORR which includes those just after 24 wks was 50 (20 CR, 30 PR) having a disease handle price of 68 . Of 15 evaluable stage IV pts, 8 (53 ) pts have been responders. In 24 remedy na e pts BORR was 58 (21 CR, 37 PR) and in 20 pts who had failed 1 therapies, BORR was 40 (20 CR, 20 PR). Preliminary serial peripheral blood analyses demonstrated in 75 of responders a sustained two fold induction with the Th1 cytokines IFN-gamma and/or TNF-alpha when compared with baseline at day 0. In contrast, 12 of non-responders demonstrated equivalent induction. F.