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.