Spots Global Cancer Trial Database for Intratumoral CAVATAK (CVA21) and Ipilimumab in Patients With Advanced Melanoma (VLA-013 MITCI)

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Trial Identification

Brief Title: Intratumoral CAVATAK (CVA21) and Ipilimumab in Patients With Advanced Melanoma (VLA-013 MITCI)

Official Title: A PHASE 1b STUDY OF INTRATUMORAL CAVATAK® (COXSACKIEVIRUS A21, CVA21) AND IPILIMUMAB IN PATIENTS WITH ADVANCED MELANOMA (VLA-013 MITCI)

Study ID: NCT02307149

Conditions

Melanoma

Interventions

CAVATAK

Ipilimumab

Study Description

Brief Summary: Open label, single arm study of intratumoral CVA21 and ipilimumab in advanced melanoma patients.

Detailed Description: 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: 1. 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. 2. Assess the response of injected and non-injected melanoma lesions after CVA21 and ipilimumab. 3. Assess the time to initial response.