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
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.
• 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.
• If patient is in irPD (unconfirmed) status, they must not have had a decrease in their Karnofsky Performances Scale (KPS) score greater than 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.
• Patients must start treatment in the extension protocol within 8 weeks of their last injection administered in the core protocol.
Brendan Curti, M.D.
- Oncology and Hematology Care Eastside