Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma

Inclusion Criteria:

Provided informed consent prior to initiation of any study-specific activities/procedures
Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended
Candidate for intralesional therapy
Measurable disease with greatest diameter ≥ 10 mm
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function

Other Inclusion Criteria May Apply

Exclusion Criteria:

Clinically active cerebral metastases.
Bone metastases
Primary ocular or mucosal melanoma
Active herpetic skin lesions or prior complications of herpes simplex virus type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis)
Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use
Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception

Other Exclusion Criteria May Apply