Phase Ib Study of Intratumoral CAVATAK (Coxsackievirus A21) and Ipilimumab in Patients with Advanced Melanoma
This study will employ a phase Ib design using the established dose of CAVATAK with ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care.
• Patients with unresectable or metastatic stage IIIB/C or IV melanoma. Patients enrolled under this version of the protocol must also have progressed on only one prior anti PD-1 therapy, according to RECIST 1.1 criteria. Patients who progressed within 3 months of treatment start are excluded.
• Patients must have at least one cutaneous or subcutaneous tumor, measuring 0.5 to 5.0 cm in the longest diameter, or a palpable lymph node. At least one tumor must qualify as an index lesion that can be accurately and reproducibly measured in two dimensions for which the longest diameter is .10 mm (.15 mm in short axis diameter [SAD] for lymph nodes), and be amenable to intratumoral injection.
• Patients with ≤ 3 visceral metastases (excluding pulmonary lesions), with no lesions >3.0 cm. Patients with substantial tumor burden of non-measurable disease may not be good candidates for an immunotherapy and should be discussed with the Medical Monitor.
Brendan Curti, M.D.
- Oncology and Hematology Care Eastside