Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec

Key Inclusion Criteria:

Male or female age ≥ 18 years with histologically confirmed diagnosis of melanoma and
unresected stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c regardless of prior line of therapy.
Subject is candidate for intralesional therapy administration into cutaneous, subcutaneous,
or nodal disease and must also have measurable disease, serum lactate dehydrogenase ≤ 1.5 x
upper limit of normal, and Eastern Cooperative Oncology Group (ECOG) performance status of
0 or 1, and adequate hematologic, hepatic, and renal organ function.

Key Exclusion Criteria:

Subject must not have clinically active cerebral metastases, greater than 3 visceral
metastases (this does not include lung metastases or any nodal metastases associated with
visceral organs) or any bone metastases melanoma, primary ocular or mucosal melanoma,
history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis,
or symptomatic autoimmune disease, or evidence of immunosuppression for any reason. Subject
known to have acute or chronic active hepatitis B or hepatitis C infection, or human
immunodeficiency virus infection will also be excluded. Subject who has active herpetic
skin lesions or prior complications of herpes simplex virus type 1 ( HSV-1) infection (eg,
herpetic keratitis or encephalitis), and/or requires intermittent or chronic systemic
(intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than
intermittent topical use will also be excuded. Subject must not have received previous
treatment with talimogene laherparepvec.