REO 024 is an open-label Phase Ib trial to determine the safety and dose-limiting toxicity of REOLYSIN® in combination with pembrolizumab (KEYTRUDA®) and chemotherapy in patients with histologically confirmed, advanced or metastatic pancreatic adenocarcinoma who have failed, or did not tolerate, first-line treatment. Following an initial six to nine patient safety run-in, up to an additional fifteen patients may be enrolled. Patients will receive chemotherapy – either gemcitabine, irinotecan or leucovorin, based on the treating physician’s preference – on day one of each twenty-one day treatment cycle, in addition to REOLYSIN® on days one and two, and pembrolizumab on day 8. The primary objectives are safety and dose-limiting toxicity. Secondary objectives include overall response rate and progression-free survival by immune-related response criteria, overall survival, and the effects of the treatment combination as determined by analysis of pre- and post-treatment biopsies and blood-based immune markers.
REO 024 is the first clinical study examining the effects of REOLYSIN® in combination with a checkpoint inhibitor.