Preliminary results from phase II study of combination treatment with HF10, a replication-competent HSV-1 oncolytic virus, and ipilimumab in patients with stage IIIb, IIIc, or IV unresectable or metastatic melanoma.

Abstract

9543Background: HF10 is a replication-competent oncolytic virus derived from HSV-1. We report on preliminary safety data and antitumor activity of HF10 + ipilimumab (ipi) combination in an ongoing Phase 2 trial in melanoma. Methods: Key entry criteria: age ≥ 18 yrs, ECOG ≤ 2, Stage IIIB, IIIC or IV unresectable/unresected melanoma, ipi naive (IV administration) and measurable non-visceral lesion(s) suitable for injection. HF10 injected into single or multiple tumors (1 x 107 TCID50/mL/dose, up to 5mL depending on tumor size and number); 4 injections q1wk; then up to 15 injections q3wk. Four ipi IV infusions (3 mg/kg; concurrent with HF10) are administered at q3wk. AEs assessed per CTCAE 4.0. Tumor responses assessed per mWHO and irRC at 12, 18 and 24 wks and at 36 and 48 wks, for patients (pts) continuing on HF10 monotherapy. Primary endpoint is Best Overall Response Rate (BORR) at 24 wks. Dose limiting toxicity defined as ≥ G3 nonhematologic/hematologic toxicity, ≥ G2 neurologic toxicity or allergic even...