At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
CVA21biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Dosing for up to 48 Weeks Total (VLA-008 CALM Ext)
In Brief
A Phase 2 clinical trial evaluating CVA21 for Melanoma. Completed, enrolled 16 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionApr 2016
TodayJul 2026
First PostedJul 10, 2012
Enrollment StartJul 3, 2012
Primary CompletionApr 6, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.0 years ago
Interventions
CVA21biological