Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Previously Untreated, Unresectable, Stage IIIb-IV Melanoma

Inclusion Criteria:

- Histologically confirmed diagnosis of malignant melanoma.

- Stage IIIb, IIIc, IVM1a, IVM1b, or IVM1c disease that is not suitable for surgical
resection

- Treatment naïve: Must not have received any prior systemic anticancer treatment
consisting of chemotherapy, immunotherapy, or targeted therapy for unresectable stage
IIIb to IV melanoma.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate hematologic, hepatic, renal, and coagulation functions

Exclusion Criteria:

- Primary uveal or mucosal melanoma

- History or evidence of melanoma associated with immunodeficiency states (eg,
hereditary immune deficiency, organ transplant, or leukemia)

- History or evidence of central nervous system (CNS) metastases

- History or evidence of gastrointestinal inflammatory bowel disease (ulcerative
colitis or Crohn disease) or other symptomatic autoimmune disease

- History of or plan for splenectomy or splenic irradiation

- Active herpetic skin lesions

- Requires intermittent or chronic systemic (intravenous or oral) treatment with an
antiherpetic drug (eg, acyclovir), other than intermittent topical use

- Known human immunodeficiency virus (HIV) disease

- Known acute or chronic hepatitis B or hepatitis C infection