Clinical Trial: Study of Intratumoral CAVATAK™ (Coxsackievirus A21) and Ipilimumab in Patients With Advanced Melanoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase Ib Study of Intratumoral CAVATAK™ (Coxsackievirus A21) and Ipilimumab in Patients With Advanced Melanoma

Brief Summary: The study will use the established dose of CAVATAK with ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. Treatment with CAVATAK will be on days 1, 3, 5 and 8 and then both agents will be co-administered on days 22, 43, 64 and 85. Patients with clinical benefit can continue CAVATAK every 3 weeks for up to one year,

Detailed Summary:
Sponsor: Viralytics

Current Primary Outcome: Safety/ tolerance of multiple intratumoral injections of CAVATAK when given in conjunction with ipilimumab as assessed by incidence of dose-limiting toxicities (DLT). [ Time Frame: Up to 106 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Estimate the objective response rate to CAVATAK and ipilimumab in patients with metastatic melanoma using irRC-WHO criteria [ Time Frame: Up to 106 days ]

Original Secondary Outcome: Same as current

Information By: Viralytics

Dates:
Date Received: November 26, 2014
Date Started: February 2015
Date Completion: September 2017
Last Updated: April 20, 2017
Last Verified: April 2017