Immunde Design- ID-LV305-2013-001- A Phase 1, Open-Label Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of Intradermally Administered ID-LV305 in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1. Site-Specific Amendment: LV305 with anti-PD-1 antibody therapy for patients with melanoma who have inadequately responded to anti-PD-1 therapy

Primary: • To evaluate the safety and tolerability of multiple ascending doses of intradermally (ID) administered LV305 in patients with locally advanced, relapsed, or metastatic cancer expressing NY-ESO-1 up through seven days after the second injection of LV305 (Study Day 28) • Part 2, Site-Specific Amendment: Assess the safety and tolerability of LV305 and pembrolizumab therapy used as treatment in eligible melanoma patients who have had an inadequate response to prior anti-PD-1 therapy

July 11, 2016