Primary Objective:~To evaluate the safety and efficacy of CAVATAK (CVA21) administered intratumorally in combination with the approved dose and schedule of ipilimumab. Of particular interest is to estimate the overall response rate (ORR) in the subgroup of subjects with unresectable or metastatic stage III B/C or IV melanoma who have progressed on a single prior anti-PD-1 therapy.~Secondary Objectives:~Assess the clinical efficacy of ipilimumab in combination with intratumoral CVA21 in terms of:~Immune-related progression-free survival (irPFS) at 6 and 12 months,~Durable response rate (DRR),~1-year survival,~Overall survival (OS), and~Quality of life.~Assess the response of injected and non-injected melanoma lesions after CVA21 and ipilimumab.~Assess the time to initial response.
Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma patients.