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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: July 5, 2012
Last updated: July 23, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Biological: Coxsackievirus A21
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Dosing for up to 48 Weeks Total

Resource links provided by NLM:

Further study details as provided by Viralytics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 67
Study Start Date: June 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAVATAK extension
Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
Biological: Coxsackievirus A21


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1. Patients must have reached Week 24 of the core protocol in immune-related complete response (irCR), immune-related partial response (irPR), immune-related stable disease (irSD), or immune-related progressive disease (irPD) (unconfirmed) with evidence of tumor inflammatory reaction.
  • 2. If patient is in irPD (unconfirmed) status, they must not have had a decrease in their Karnofsky Performances Scale (KPS) score > 10 points and to be judged to not have "rapid clinical deterioration" by the investigator since the subject's last tumor measurement leading to irPD assessment.
  • 3. Patients must start treatment in the extension protocol within 8 weeks of their last injection administered in the core protocol.
  • 4. Patient is able and willing to provide written informed consent to participate in the study.
  • 5. Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males.

Exclusion Criteria:

  • 1. Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.
  • 2. If lesions are too small to be visualized or palpable for accurate injection.
  • 3. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of tumor inflammatory response, or with rapid clinical deterioration, or with a decrease of 10 points or more on their KPS score since their last assessment before irPD (unconfirmed) assessment.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01636882

United States, Illinois
Oncology Specialists
Park Ridge, Illinois, United States
United States, Oregon
Providence Medical Centre
Portland, Oregon, United States
United States, Texas
Mary Crowley Medical Center
Dallas, Texas, United States
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Principal Investigator: Jose Lutzky, MD Icahn School of Medicine at Mount Sinai
  More Information

No publications provided

Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT01636882     History of Changes
Other Study ID Numbers: VLA 008
Study First Received: July 5, 2012
Last Updated: July 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 25, 2015