Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Advanced Melanoma

Key inclusion criteria: * Japanese patients with histologic diagnosis of malignant melanoma * Previously untreated Stage III with N3 (unresectable) or Stage IV melanoma * Prior adjuvant melanoma therapy permitted * Eastern Cooperative Oncology Group performance status of 0 or 1 * Life expectancy of at least 16 weeks in this study * Adequate bone marrow and renal and hepatic function, specifically: * white blood cell count ≥2500/uL, absolute neutrophil count ≥1000/uL, platelet count ≥75,000/uL, hemoglobin level ≥9.0 g/dL, creatinine level ≤2.5\*upper limit of normal (ULN), aspartate transaminase/alanine transaminase level \<2.5\*ULN for patients without liver metastasis and \<5\*ULN for patients with liver metastasis, total bilirubin level \<1.5\*ULN (for those with Gilbert's Syndrome, lower than 3.0 mg/dL) Key exclusion criteria: * Evidence of brain metastases on brain imaging * Active brain metastases with symptoms or requiring corticosteroid treatment; patients with any other malignancy from which they have been disease-free for fewer than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix * Primary ocular or mucosal melanoma * History of or current active autoimmune disease * History or concurrent disease of gastrointestinal perforations * HIV infection; active Hepatitis B or C or human T-lymphotropic virus type1 infection, based on testing performed during the screening period of this study * Prior or concomitant therapy with any anticancer agent for melanoma, or other investigational anticancer therapies * Prior adjuvant therapy \<4 weeks prior to the start of study drug administration * Concomitant therapy with immunosuppressive agents, surgery, or radiotherapy * Prior treatment with CTLA-4 inhibitors/agonists or other experimental immunotherapy drugs * Treatment with other investigational products within 4 weeks prior to initial treatment of study drug