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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center,, Duarte, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
The Angeles Clinic & Research Institute, Los Angeles, California, United States
John Wayne Cancer Institute, Santa Monica, California, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Advocate Health, SC, Park Ridge, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Atlantic Melanoma Center, Morristown, New Jersey, United States
Providence Portland Medical Center, Portland, Oregon, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Name: Brendan Curti, MD
Affiliation: Providence Health & Services
Role: PRINCIPAL_INVESTIGATOR