Intratumoral CAVATAK (CVA21) and Pembrolizumab in Patients With Advanced Melanoma (VLA-011 CAPRA)

Inclusion criteria

• Subjects with metastatic or unresectable stage IIIb/c of IV melanoma for whom treatment with pembrolizumab is indicated and who have at least one cutaneous, subcutaneous tumor or palpable lymph node amenable to intratumoral injection.
• At least one tumor must qualify to be an index lesion for modified WHO criteria.
• Subjects must have adequate hematologic, hepatic and renal function.
• ECOG performance status of 0 or 1.
• Anticipated lifespan greater than 12 weeks

Exclusion criteria

• Ocular primary tumors.
• Presence of any central nervous system tumor that has not been stable for at least 4 weeks off corticosteroids.
• Tumors lying in mucosal regions or close to an airway, major blood vessel or spinal cord.
• Subjects with active, known or suspected autoimmune or immunosuppressive disease.
• Subjects previously treated with CVA21.
• Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days prior to the first treatment.
• Subject has received chemotherapy within the last 4 weeks prior to first treatment.
• Clinically significant cardiovascular disease.
• Females of childbearing potential must have negative serum or urine pregnancy test.
• Subjects requiring or using other investigational agents while on treatment in this trial.
• History of other malignancy within the last 3 years (with exceptions).
• Active infection requiring systemic therapy.
• Known history of HIV disease, active hepatitis B or hepatitis C.
• History or evidence of other clinically significant disorders that would pose a risk to subject safety.
• Inability to give informed consent and comply with the protocol.