Clinical Trial: Phase I Study of Intratumoral CAVATAK™ and Pembrolizumab in Subjects With Advanced Melanoma

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

Official Title: Phase I Study of Intratumoral CAVATAK™ (Coxsackievirus A21) and Pembrolizumab in Subjects With Advanced Melanoma

Brief Summary: This study will employ a phase Ib design using the established dose of CAVATAK with pembrolizumab in subjects with advanced melanoma for whom pembrolizumab would be considered standard of care. Our hypothesis is that oncolysis of melanoma cells by CAVATAK will be important in amplifying the T-cell potentiating effects of pembrolizumab.

Detailed Summary:
Sponsor: Viralytics

Current Primary Outcome: The incidence of dose-limiting toxicities (DLT) of intravenous pembrolizumab in combination with intratumoral CAVATAK will be assessed using CTCAE v. 4.0. [ Time Frame: Up to 2 years ]

Original Primary Outcome: To assess the safety and tolerability of intravenous pembrolizumab in combination with intratumoral CAVATAK by incidence of dose-limiting toxicities. [ Time Frame: Up to 2 years ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Viralytics

Dates:
Date Received: September 30, 2015
Date Started: October 2015
Date Completion: January 2019
Last Updated: April 11, 2017
Last Verified: April 2017