CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
Coxsackievirus A21 (CVA21)biological
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.

Search/NCT01227551
NCT01227551Phase 2Completed
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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 (VLA-007 CALM )

Viralytics·interventional·Posted Oct 25, 2010·Updated Jul 5, 2019

In Brief

A Phase 2 clinical trial evaluating Coxsackievirus A21 (CVA21) for Malignant Melanoma. Completed, enrolled 57 participants across 10 sites.

Detailed Summary

The purpose of this study is to assess the clinical efficacy of Intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months as monitored via immune-related Response Criteria \[irRECIST 1.1\] (revised Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2010
Enrollment StartDec 29, 2011
Primary CompletionApr 6, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.7 years ago

Interventions

Coxsackievirus A21 (CVA21)biological

CVA21 is a live oncolytic virus preparation derived from the non-genetically altered prototype Kuykendall strain of Coxsackievirus A21.