Clinical Trial: Efficacy and Safety of Intratumoral CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2 Study of the Efficacy and Safety of Intratumoral CAVATAK™ (Coxsackievirus A21, CVA21) in Patients With Stage IIIc and Stage IV Malignant Melanoma to Extend

Brief Summary: This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA 007 trial. There may be patients who have benefitted from the study drug and who might benefit from further treatment. In order to accommodate those patients further treatment to complete 48 weeks of CVA21 intratumoral injections will be made available.

Detailed Summary:
Sponsor: Viralytics

Current Primary Outcome: To assess the clinical efficacy of intratumoral (IT) CVA21 when given beyond 18 weeks using immune-related Progression-Free Survival (irPFS) [ Time Frame: Up to 48 weeks ]

Original Primary Outcome: To assess the clinical efficacy of intratumoral (IT) CVA21 when given beyond 18 weeks using immune-related Progression-Free Survival (irPFS)

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Viralytics

Dates:
Date Received: July 5, 2012
Date Started: June 2012
Date Completion:
Last Updated: May 9, 2017
Last Verified: May 2017